Generics and Biosimilars: Barriers and Opportunities

Abstract

The affordability of prescription drugs continues to occupy a significant position in health policy debate, with most Americans believing that lowering their cost is a top health care priority.1Kirzinger A. DiJulio B. Sugarman E. Brodie M. Kaiser health tracking poll – late April 2017: the future of the ACA and health care & the budget. Kaiser Family Foundation website.http://www.kff.org/health-reform/report/kaiser-health-tracking-poll-late-april-2017-the-future-of-the-aca-and-health-care-the-budget/Google Scholar,2Kirzinger A. Wu B. Brodie M. Kaiser health tracking poll: September 2016. Kaiser Family Foundation website.http://www.kff.org/health-costs/report/kaiser-health-tracking-poll-september-2016/Google Scholar Prescription drugs account for 10% of overall health spending in the United States, with prescription sales in 2016 exceeding $448 billion.3Martin A.B. Hartman M. Washington B. Catlin A. National Health Expenditure Accounts TeamNational health spending: faster growth in 2015 as coverage expands and utilization increases.Health Aff (Millwood). 2017; 36: 166-176Crossref PubMed Scopus (89) Google Scholar The annual increase in pharmaceutical costs consistently outpaces inflation, and in this context, much attention has been devoted to various strategies to rein in pharmaceutical expenditures. New prescription drugs are relatively immune to free market competition on price because prolonged patent protections offered to them pose a significant barrier to the entry of competitors. Although this monopoly protection rewards innovation, when unduly prolonged it has a detrimental effect by allowing high unchecked prices to continue. One of the ways to bring prescription drugs into alignment with conventional free market principles is to encourage the entry of generics and biosimilars than can compete with the original innovator compound on price, once a reasonable period of protected status has elapsed. In this article, we explore the history and value of generics and biosimilars, barriers to full utilization, and the potential solutions that would help lower the cost of prescription drugs. The US patent system promotes the research and development of new pharmaceuticals by allowing patent holders (drug manufacturers) a period of market exclusivity during which they will ideally recoup their investment and enjoy profits that will fund future research.4Kewanee Oil Co v Bicron Corp, 416 US 470. 1974: 480Google Scholar,5US Const, art I, §8, cl 8.Google Scholar Generic drugs are the therapeutic equivalents of their brand-name counterparts. They are identical with regard to active ingredients, indication and use, dosage, route of administration, safety, and quality. The Drug Price Competition and Patent Term Restoration Act (commonly referred to as Hatch-Waxman) was signed into law in 1984 and substantially expanded the generic pharmaceutical industry.6Drug Price Competition and Patent Term Restoration Act, Pub L No. 98-417, §101, 98 Stat 1585. 1984Google Scholar Under Hatch-Waxman, a generic drug maker may use an abbreviated new drug application (ANDA) instead of the more complicated new drug application to gain US Food and Drug Administration (FDA) approval. With an ANDA, the generic drug maker must verify both the bioavailability and bioequivalence of their product in comparison to the brand-name agent but is not required to reproduce the stringent and expensive safety and clinical efficacy studies that yielded the original product approval. Biosimilars are nonoriginal biological medicines with an active ingredient that mirrors the reference biological and have no clinically meaningful difference in safety, potency, or efficacy. The Biologics Price Competition and Innovation Act of 2009, a part of the Affordable Care Act, paved the pathway for FDA approval of biosimilars.7The Patient Protection and Affordable Care Act, Pub L No. 111-148, Title VII, 124 Stat 199. 2010: 804-821Google Scholar Similar to generics, biosimilars are not required to reproduce the original clinical data and can instead file an abbreviated biologics license application. The abbreviated approval process and lower up-front costs of biosimilars entice the entry of additional drug manufacturers to the market after the loss of patent protection and ultimately should lower prices for consumers. Generic medicines have become an integral part of the pharmaceutical system, representing 9 out of every 10 US prescriptions,8IQVIA Institute for Human Data ScienceMedicine spending and affordability in the United States: understanding patients’ costs for medicines.https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicine-spending-and-affordability-in-the-united-states.pdf?_=1614710909057Google Scholar yet they only account for 20% of pharmaceutical spending. As generics are approved, they sell at lower prices than the brand-name drug, and the price of the generic typically declines as more generic manufacturers for the same drug enter the market. An FDA analysis of prescription drug invoice-based wholesale prices revealed that for drugs with initial generic competition entering the market between 2015 and 2017, invoice prices dropped on average by 31% with 1 generic competitor, 44% with 2 generic competitors, and 73% with 4 generic competitors.8IQVIA Institute for Human Data ScienceMedicine spending and affordability in the United States: understanding patients’ costs for medicines.https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicine-spending-and-affordability-in-the-united-states.pdf?_=1614710909057Google Scholar Another analysis found that within a year of the loss of brand exclusivity, generic drugs cost less than half as much as the brand-name drug, and within 3 years, generics are a third of the brand-name drug’s price.9Conrad R. Lutter R. Generic competition and drug prices: new evidence linking greater generic competition and lower generic drug prices. US Food and Drug Administration website.https://www.fda.gov/media/133509/downloadGoogle Scholar In 2019, generics saved American patients $313 billion, and they have resulted in almost $2.2 trillion in savings over the past decade.102020 Generic drug & biosimilars access & savings in the U.S. report. Association for Accessible Medicines website.https://accessiblemeds.org/sites/default/files/2020-09/AAM-2020-Generics-Biosimilars-Access-Savings-Report-US-Web.pdfDate accessed: March 17, 2021Google Scholar Biologicals represent a growing segment of the pharmaceutical market in the United States, representing $211 billion or 43% of invoice-level spending in 2019.11IQVIA Institute for Human Data ScienceBiosimilars in the United States 2020-2024: competition, savings, and sustainability.https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024Date accessed: March 16, 2021Google Scholar As of June 2020, there have been 33 biosimilar approvals across 13 molecules; however, biosimilars for only 11 molecules are currently marketed. These 11 molecules account for approximately $40 billion or 19% of the overall biological market that is now open to biosimilar competition. Biosimilars that are FDA-approved but have not been launched (2 molecules) represent an additional 17% of biological spending that will be exposed to biosimilar competition when they are launched. Currently, $67 billion or 32% of the biological market has biosimilars in development. The percentage of the market share penetration following biosimilar launch has been variable. For example, as of June 2020, the infliximab biosimilar had the lowest uptake at 6% since its launch in 2016, whereas bevacizumab had the highest biosimilar uptake with 2 competitors achieving 42% of the market within 1 year. The price decline between original and biosimilar average sales price has been variable, with savings ranging from 8.1% to 48.3%. From 2015, when the first biosimilar was launched, through the end of 2018, biosimilars saved the US health system $882 million.102020 Generic drug & biosimilars access & savings in the U.S. report. Association for Accessible Medicines website.https://accessiblemeds.org/sites/default/files/2020-09/AAM-2020-Generics-Biosimilars-Access-Savings-Report-US-Web.pdfDate accessed: March 17, 2021Google Scholar Next we explore the practices of 2 key stakeholders, payers and manufacturers, that may undermine the role of generics and biosimilars in achieving prescription drug savings and some potential solutions. Insurance companies negotiate prices with health care providers and drug companies, provide partial coverage or reimbursement for medical expenses, and collect premiums from plan members to fund these activities. Many insurers are private companies and seek to make a profit by having policy premiums exceed the costs of providing benefits. Tier switching and delays in generic/biosimilar switching are barriers to optimal market savings. Medicare beneficiaries have access to prescription drug benefits when enrolled in Part D. This insurance can be purchased either as a stand-alone plan or in conjunction with medical benefits through a Medicare Advantage plan. Prescription drug coverage and cost sharing were categorized through the placement of pharmaceuticals on 4 to 5 tiers, with lower cost sharing burden for drugs on lower tiers (tiers 1 and 2) and more cost sharing for those on higher tiers (tiers 3 through 5). Most recently, formularies have used 2 generic tiers (preferred and nonpreferred), 2 brand tiers (preferred and nonpreferred), and a specialty tier.12A study for the Medicare Payment Advisory Committee (MedPAC)Medicare Part D Formularies, 2006-2010: A Chartbook.2010http://67.59.137.244/documents/Oct10_PartDFormulariesChartBook_CONTRACTOR_RS.pdfDate accessed: March 17, 2021Google Scholar,13Hoadley J. Cubanski J. Neuman T. Medicare Part D in 2016 and trends over time. Kaiser Family Foundation website.https://www.kff.org/medicare/report/medicare-part-d-in-2016-and-trends-over-time/Google Scholar Prior to 2017, the Centers for Medicare and Medicaid Services (CMS) allowed plans flexibility in creation of their formularies as long as they met certain requirements: (1) tier labels (brand or generic) must correspond to the majority of drugs placed within the tier and (2) cost sharing for each tier could not exceed certain maximums. However, in 2017 the CMS issued a rule change that allowed plans the option of using either a nonpreferred drug or nonpreferred brand tier and flexibility in the proportion of brand-name drugs and generics that could go into this tier.14Centers for Medicare and Medicaid ServicesAdvance notice of methodological changes for calendar year (CY) 2017 for Medicare Advantage (MA) capitation rates, Part C and D payment policies and 2017 call letter.https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2017.pdfGoogle Scholar Adoption was swift, with 99% of stand-alone prescription drug plans and 89% of Medicare Advantage plans using the nonpreferred drug tier by 2019.15Brantley K. Donthi S. Sloan C. Young J. Effect of potential policy change to Part D generic tiering on patient cost sharing and Part D plan costs. Avalere Health website.https://avalere.com/insights/effect-of-potential-policy-change-to-part-d-generic-tiering-on-patient-cost-sharing-and-part-d-plan-costsGoogle Scholar In 2016 (prior to the rule change), plans placed generics in generic tiers 65% of the time (14% in tier 1 and 51% in tier 2). Generic distribution among brand-name drug tiers was 33% (15% in tier 3 and 18% in tier 4), and the remaining went into the specialty tier. In 2019, 53% of generics were in generic tiers (14% in tier 1 and 39% in tier 2) and generic placement in preferred brand, and the newly renamed nonpreferred drug tiers grew to 18% and 25%, respectively.16Alliance for Affordable MedicinesMedicare Part D generic drug tiering request for comment: implications for patient out-of-pocket spending and Part D plan costs.https://accessiblemeds.org/resources/reports/medicare-part-d-generic-tieringGoogle Scholar The movement of generics into higher tiers results in more cost sharing for patients, represented as higher copays or a higher percentage of the drug cost (coinsurance). Analysis by Avalere Health revealed that from 2016 to 2019, if generic drugs had only been placed on generic tiers, patient cost sharing would have been $15.7 billion lower.15Brantley K. Donthi S. Sloan C. Young J. Effect of potential policy change to Part D generic tiering on patient cost sharing and Part D plan costs. Avalere Health website.https://avalere.com/insights/effect-of-potential-policy-change-to-part-d-generic-tiering-on-patient-cost-sharing-and-part-d-plan-costsGoogle Scholar The implications of switching generics to higher tiers are real, as prior studies have documented that lower cost sharing results in increased medication initiation and adherence.17Bao Y. Ryan A.M. Shao H. Pincus H.A. Donohue J.M. Generic initiation and antidepressant therapy adherence under Medicare Part D.Am J Manag Care. 2013; 19: 989-998PubMed Google Scholar,18Hoadley J.F. Merrell K. Hargrave E. Summer L. In Medicare Part D plans, low or zero copays and other features to encourage the use of generic statins work, could save billions.Health Aff (Millwood). 2012; 31: 2266-2275Crossref PubMed Scopus (22) Google Scholar In response to concerns voiced about the evolution of generic allocation in tiers, the CMS has considered restricting generics being placed in brand tiers.19Centers for Medicare and Medicaid Services2020 Medicare Advantage and Part D advance notice Part II and 2020 draft call letter.https://www.cms.gov/newsroom/fact-sheets/2020-medicare-advantage-and-part-d-advance-notice-part-ii-and-draft-call-letter/Google Scholar Generics should be placed only in tiers designated for generics and not in tiers for branded or specialty drugs. Generic specialty drugs and biosimilars should have their own tier as a means of incentivizing beneficiaries to use them. In an effort to maintain stable insurance premiums, a plan may place generics in higher tiers, thus decreasing plan liability for drug costs by increasing patient cost sharing. This annual balance between preserving consistent access to benefits while keeping competitive premiums in relationship to other insurance plans is known as actuarial equivalence. Of note, the same analysis by Avalere Health revealed that plan liabilities for prescription drugs would have been 4.5% higher in 2019 if generics were included only in generic tiers.15Brantley K. Donthi S. Sloan C. Young J. Effect of potential policy change to Part D generic tiering on patient cost sharing and Part D plan costs. Avalere Health website.https://avalere.com/insights/effect-of-potential-policy-change-to-part-d-generic-tiering-on-patient-cost-sharing-and-part-d-plan-costsGoogle Scholar The magnitude of the downstream effects of higher out-of-pocket expenses due to tier switching, including prescription abandonment and nonadherence, are unknown. However, because cost sharing impacts medication compliance, we would recommend against the use of tier switching to preserve actuarial equivalence. Understanding that tier switching helps mitigate premium increases, other cost control strategies would be necessary to keep premiums stable if the aforementioned changes were implemented. As generics become available for specific drugs, the assumption is that plans would quickly include them in their formularies and substitute them for brand-name drugs to promote access to a lower cost alternative for their beneficiaries. Indeed, some plans incentivize their members to switch to generics by differing the out-of-pocket cost to consumer if they choose generic vs brand-name drugs. However, this substitution does not always happen. A 2018 study by the US Department of Health and Human Services found that Medicare Part D spent $9 billion on brand-name drugs for which generics were available.20US Department of Health and Human ServicesOffice of the Assistant Secretary for Planning and Evaluation. Savings available under full generic substitution of multiple source brand drugs in Medicare Part D.https://aspe.hhs.gov/system/files/pdf/259326/DP-Multisource-Brands-in-Part-D.pdfGoogle Scholar It is estimated that $3 billion could have been saved if those generics had been substituted. A 2020 study by Avalere Health revealed that in 2017, generic substitution rates among non–low-income subsidy Medicare Part D plans was 75% or less in 48% of plans.21Fix A. Sloan C. Young J. Donthi S. Meltzer R. Variation in generic substitution rates among Part D plans. Avalere Health website.https://avalere.com/insights/avalere-analysis-finds-variation-in-generic-substitution-rates-among-part-d-plansGoogle Scholar Because Medicare Part D beneficiaries are unevenly distributed across plans and substitution rates vary by plan operator, the weighted average of generic substitution in 2017 was 85%. This proportion contrasts with the average generic substitution rate of 98% in commercial plans.22US Office of Personnel Management, Healthcare and InsuranceFEHB program carrier letter.www.opm.gov/healthcare-insurance/healthcare/carriers/2019/2019-01.pdfGoogle Scholar,23Utilization Review Accreditation CommissionURAC pharmacy benefit management performance measurement: aggregate summary performance report.https://www.urac.org/wp-content/uploads/2020/12/URAC_PBM_Aggregate-Summary-Report_2018_FINAL_WebVersion_20190123.pdfGoogle Scholar Generic substitution rates also vary by the price of the brand-name drug. Avalere Health found that 91% of plans will substitute a generic for a brand-name drug at least 75% of the time when the brand-name drug costs less than $100. However, only 22% of plans do this when the price of the brand-name drug exceeds $10,000.21Fix A. Sloan C. Young J. Donthi S. Meltzer R. Variation in generic substitution rates among Part D plans. Avalere Health website.https://avalere.com/insights/avalere-analysis-finds-variation-in-generic-substitution-rates-among-part-d-plansGoogle Scholar Delays in generic substitution are especially pronounced when the first generic for a brand-name drug becomes available. Research by the Association for Accessible Medications revealed that in up to half of Part D plans, it takes 3 years before a first generic becomes available in the formulary.24Association for Accessible MedicationsAccess denied: why new generics are not reaching America’s seniors.https://accessiblemeds.org/sites/default/files/2019-09/AAM-White-Paper-Access-Denied-First-Generics-web_0.pdfGoogle Scholar These deficiencies in generic substitution can in part be attributed to the Medicare Coverage Gap Discount Program and how brand-name drug rebates work in the catastrophic phase of Part D coverage. Medicare Part D coverage and the cost sharing between patients, manufacturers, plans, and Medicare vary depending on which phase patients are in. The dollar thresholds for these limits change annually. After a patient meets their deductible, they are in the initial coverage phase in which beneficiaries pay 25% and the plan pays 75%. In the coverage gap phase, cost sharing differs between brand-name and generic drugs. For brand-name drugs, patients pay 25%, plans pay 5%, and the drug manufacturer must provide a 70% discount. The manufacturer discount is counted toward the patient’s catastrophic out-of-pocket spending threshold. For generics, patients pay 25% and plans pay 75%. Once in the catastrophic coverage phase, patients pay 5%, plans pay 15%, and Medicare pays 80%25Kaiser Family FoundationAn overview of the Medicare Part D prescription drug benefit.https://www.kff.org/medicare/fact-sheet/an-overview-of-the-medicare-part-d-prescription-drug-benefit/Google Scholar (Figure 1). Because of the difference in plan liability for brand-name vs generic drugs in the coverage cap (5% vs 75%), plans pay more for generics in the coverage gap even though the price of the generic is cheaper. Dusetzina et al26Dusetzina S.B. Jazowski S. Cole A. Nguyen J. Sending the wrong price signal: why do some brand-name drugs cost Medicare beneficiaries less than generics?.Health Aff (Millwood). 2019; 38: 1188-1194Crossref PubMed Scopus (15) Google Scholar found that patients may pay higher prices for generics vs brand-name drugs during the coverage gap. The preference for brand-name drugs during the coverage gap may exert negative market forces on generic competition, a necessity to bring down prices. When the more expensive brand-name drug is preferred, plan liability may be lower but patients move quickly into catastrophic coverage, in which Medicare takes on the bulk of financial liability and manufacturer rebate sharing between the plan and Medicare significantly favors the plan. These differences in rebate sharing may allow a plan to make money on a brand-name drug and incentivizes plan preference for the brand-name drug, even though the out-of-pocket cost for patients and the total cost to Medicare is higher. This is one example of the “rebate trap.” Figure 2 (part A) illustrates a simplistic example of a rebate trap for commercial plans. On entry of a biosimilar or generic, some brand-name drug manufacturers have threatened to remove rebates they provide to payors unless the competitor is effectively excluded from the formulary. Because prescribing patterns may be slow to change and adoption of a generic or biosimilar may take time, the adoption of the less expensive alternative and potential loss of the rebate may result in a higher cost to the plan. An insurer is thus incentivized to keep the lower-priced competitor off its formulary. Adapted from the Medicare Payment Advisory Commission 2017 Report to Congress, Figure 2 (part B) illustrates the more complex interplay between the sharing of drug rebate and Medicare coinsurance in determining plan liability.27Medicare Payment Advisory CommissionReport to Congress: Medicare payment policy.http://medpac.gov/docs/default-source/reports/mar17_entirereport.pdfGoogle Scholar At the coinsurance rate of 80%, plans are incentivized to keep the more expensive agent in formulary and beneficiaries carry a larger financial burden. A sample adjustment of the coinsurance rate to 20% realigns plan liability with the overall cost of the therapy. Require the adoption of generics and biosimilars into formularies on FDA approval. Proposals by the Trump administration to not allow manufacturer rebates to apply toward total beneficiary spending in the Coverage Gap Discount Program would discourage the preference for brand-name drugs, slow the progression into catastrophic coverage, and thus reduce Medicare liabilities.28Department of Health and Human ServicesPutting America’s health first: FY 2020 President’s budget for HHS.https://www.hhs.gov/sites/default/files/fy-2020-budget-in-brief.pdfDate accessed: March 17, 2021Google Scholar However, this step would also substantially increase patient out-of-pocket spending because patients are now in the coverage gap longer. Restructuring plan and Medicare liability in the catastrophic coverage phase such that plans have a greater degree of cost sharing would eliminate financial incentives for plans to quickly move patients into catastrophic coverage. Indeed, these were the recommendations by the Medicare Payment Advisory Commission in 2016 and were reaffirmed in 2020.29Medicare Payment Advisory CommissionImproving Medicare Part D. In: Report to the Congress: Medicare and the Health Care Delivery System. Chapter 6.http://www.medpac.gov/docs/default-source/reports/chapter-6-improving-medicare-part-d-june-2016-report-.pdfGoogle Scholar,30Medicare Payment Advisory CommissionRealigning incentives in Medicare Part D. In: Report to the Congress: Medicare and the Health Care Delivery System. Chapter 5. Published June 2020.http://www.medpac.gov/docs/default-source/reports/jun20_ch5_reporttocongress_sec.pdf?sfvrsn=0Date accessed: March 17, 2021Google Scholar Lastly, changing the calculation of rebate sharing and coinsurance rate between plan sponsor and Medicare would challenge incentives for using high–list price, high-rebate drugs when generics or biosimilars are available. Because it is unknown the degree to which rebates are used by plan sponsors to lower premiums vs increasing profit, such a change may result in higher premiums for beneficiaries. Drug manufacturers are private companies that either bring new index products to market or produce bioequivalent versions of established drugs. The board of directors and CEO of drug manufacturers have a fiduciary responsibility to maximize profits for shareholders. Executive compensation is dictated by the board of directors and is often tied directly to company profits, share price performance, and effective corporate governance. Pharmaceutical pricing, be it brand-name or generic, reflects these corporate interests. When a generic drug manufacturer files an ANDA, it includes a paragraph IV certification that states that the generic drug manufacturer believes the patent on the brand-name drug is invalid, not infringed, or unenforceable. Under Hatch-Waxman, the filing of a paragraph IV certification is treated as an act of patent infringement and requires that the generic drug maker provide notice to the owner of the patented drug the legal basis for its patent challenge. The brand-name drug owner then has the option of suing the generic manufacturer sponsor with 45 days. If the brand-name drug owner brings a suit within this 45-day period, then the FDA can’t approve the ANDA for 30 months or until a court determines that the patents at issue are invalid or not infringed by the generic manufacturer.6Drug Price Competition and Patent Term Restoration Act, Pub L No. 98-417, §101, 98 Stat 1585. 1984Google Scholar To incentivize initial entrants into the generic market for a compound, the Hatch-Waxman Act grants a 180-day period of exclusivity to the first generic company that successfully challenges the patent of a brand-name drug. This step provides a means by which generic companies can be the sole provider of a generic drug, charge a price premium, and recoup the financial burden required to contest patents. After the 180 days lapses, other generics filers are able to enter the market. Although the 180-day exclusivity is intended as an incentive, some manufacturers have undermined this process through generic “parking.” Under Hatch-Waxman, the 180-day exclusivity period begins once the generic manufacturer is granted final marketing authorization for their generic. This means the first applicant whose ANDA is otherwise approvable could deliberately delay seeking final approval of their drug and prevent the FDA from triggering the 180-day exclusivity. Other interested generic manufacturers would have their ANDAs blocked from moving forward because of a first applicant’s continuing eligibility for the exclusivity period. Why would a generic drug manufacturer delay entering into their exclusivity period? For some manufacturers, the promise of exclusivity and the control over when to exercise it can have strategic value. Former FDA commissioner Scott Gottlieb likens this to “a call option that the generic sponsor can hold onto.”31Gottlieb S. The HELP Committee’s fix for 180-day generic marketing exclusivity: does it solve the problem? Health Affairs blog.https://doi.org/10.1377/hblog20190529.223594Google Scholar Generic manufacturers may also reach business agreements with the brand-name drug manufacturer to not launch their generic competitor and split some of the profits from the brand-name drug. This ploy effectively extends the patent of the brand-name drug. Although these agreements are decreasing in frequency following the Supreme Court’s Fed Trade Comm’n vs Actavis, Inc decision, they still occur.32Fed Trade Comm’n vs Actavis, Inc, 570 US 136. 2013: 143-144Google Scholar In the past year, several pieces of legislation have been introduced to address this issue.33BLOCKING Act of 2019. HR 938, 116th Cong, 1st Sess. 2019Google Scholar, 34Expanding Access to Low-Cost Generics Act of 2019. S 3092, 116th Cong, 1st Sess. 2019Google Scholar, 35Lower Health Care Costs Act. S 1895, 116th Cong, 1st Sess. 2019Google Scholar These proposals offer differing solutions, including loss of exclusivity if the generic manufacturer does not move through the approval process quickly enough, awarding exclusivity to the first manufacturer to successfully challenge the brand-name patents regardless of which manufacturer filed their ANDA first, and triggering the exclusivity period when a subsequent filer receives tentative approval if the original applicant hasn’t received final approval within 30 months of submission. Legislative actions to address generic parking must address the abuse while not cheapening the exclusivity period. The latter 2 solutions are more likely to promote competition among generic manufacturers and reward those actively trying to bring a generic to market. Another consideration is extending the exclusivity period. Generic manufacturers may be “parking” their drugs because of a lack of perceived value of the exclusivity period in contrast to other financial incentives. By extending the duration of the exclusivity period and potential financial gain, this step may deter generic manufacturers from accepting alternative agreements that delay access. Patents on pharmaceuticals include far more than just the active ingredient (sometimes called “primary patents”). These “secondary patents” may include drug formulations (forms or dosage), methods of use, methods of manufacturing including manufacturing technologies, unique administration technologies, and other chemicals related to the active ingredient. In addition, if a person invents an improvement on any of these technologies, they have the option of fili