Branded Drugs Research Articles

PROFIL PENGETAHUAN PENDUDUK TERHADAP OBAT GENERIK, MEREK DAN PATEN

Republic of Indonesia Law Number 36 of 2009 states that medicine is a combination of ingredients, including biological products that are used to affect or investigate physiological systems or pathological conditions in the framework of establishing a diagnosis, prevention, cure, recovery, health promotion and contraception for humans. Generic drugs are drugs whose patents have expired, so all pharmaceutical companies can produce them without the need to pay for patents. Branded drugs are drugs that are marketed under certain trade names registered by the manufacturer. Patented drugs are drugs that have just been produced and marketed by a pharmaceutical company that has had patents for 20 years. The purpose of this study was to determine the profile of the population's knowledge of generic drugs, branded drugs, and patent drugs. The descriptive observational research method by collecting primary data through questionnaires. The results of the study showed that 45 respondents (64.70%) had enough knowledge and 25 respondents (35.70%) had less knowledge. This shows that the profile of the population's knowledge of generic drugs, branded drugs, and patent drugs is considered quite good. The conclusion of this study is that the population's knowledge profile of generic drugs, branded drugs, and patented drugs is included in the sufficient category, namely 64.70%.

A Pharmacoeconomic Outlook of the Biological Drugs Marketed in India: A Cost Variance Analysis.

Introduction Biologic drugs are used to treat various illnesses like autoimmune diseases, cancers, hormonal irregularities, anemia, etc., and to prevent various diseases as vaccines. Though various biologic drugs are already available, they are still not within reach of the common man due to financial constraints. Through many search engines, studies evaluating the cost variation of different brands of biologics were investigated; however, only a few studies that address this problem were found. Hence, this study was planned with the objective of addressing the cost variation of various brands of biologic medicines available in the Indian market. Methods The website for the Current Index of Medical Specialties (CIMS) for India's location was used to obtain the prices of the different brands of biologic medicines in Indian National Rupee (INR) currency, which different manufacturers market with identical forms in strength and dosage. The percentage cost variation and cost ratio were calculated with the help of the minimum and maximum prices of various brands of biologic drugs. Results The prices of biologics belonging to six different classes that are available in 23 formulations were analyzed. The highest cost variability was shown by pegfilgrastim 6 mg at 1,022.92%, and the minimum-cost variation was shown by darbepoetin alfa 200 mcg at 13.07%. Conclusion Our research found a vast variance in the costs of various brands of biologic medicines in India. The government should address this cost variation problem by developing various policies, such as breaking the monopoly of manufacturers, providing tax incentives to nonprofit generic medicine manufacturers, and incorporating more biologic drugs under the protection of the Drugs Prices Control Order (DPCO).

Economic Evaluation of Different Brands of Commonly Prescribed Drugs Used in the Management of Angina Pectoris in Indian Market

Introduction: Coronary artery disease (CAD) is one of the most common causes of cardiovascular mortality and morbidity in developing countries like India. Initial management includes use of many anti- anginal drugs. If angina pectoris not managed adequately results in significant morbidity and mortality too due to the complications. Anti-anginal drugs are used for lifelong. Therefore, analysis of the price of different drugs used in ischemic heart disease will help to improve patient compliance. Objective: (1) To assess the cost variation of different drugs available as antianginal agents in India. (2) To assess the cost ratio and percentage price variation of different formulations. Method: The maximum and minimum price of each brand of the drugs given in Indian rupees (INR) was noted by using ‘Drug Today’ (Oct 2022 – Jan 2023, volume II). The cost range, cost ratio, and the percentage cost variation for individual drug brands were calculated. The cost of tablets/capsule was calculated, and the cost ratio and percentage cost variation of various brands was compared. Results: After calculation of cost ratio and percentage cost variation for each brand of anti-anginal drugs, tab Diltiazem (60 mg) had a maximum percentage cost variation of 459.76% and a cost ratio of 5.59 while tab GTN (6.4 mg) had a minimum percentage cost variation of 76.19% and cost ratio of 1.76. Conclusions: There is a wide variation in the price of different brands ofanti-anginal drugs available in India. The clinicians prescribing these drugsshould be aware of these variations to reduce the financial burden of drugtherapy and improve compliance.

Study of price disparities among various brands of drugs used for post-traumatic stress disorder (PTSD) in the Indian pharmaceutical market

Study of price disparities among various brands of drugs used for post-traumatic stress disorder (PTSD) in the Indian pharmaceutical market

Assessment of drug marketing literature systematically using the WHO criteria

Background: The drug promotional literature (DPL) provided by the medical representative is a crucial source of information for busy medical practitioners. It is frequently the only resource that treating doctors rely on to stay up to date on both new and existing medications. Because pharma companies are promoting the information for their own brand of drugs, there is a possibility of prejudice. Aims and Objectives: This study was conducted to assess DPL using the World Health Organization (WHO) criteria. Materials and Methods: This cross-sectional study was conducted by collecting 300 DPLs randomly from private medical hospitals and some pharmaceutical companies’ representative from Ahmedabad. The WHO criteria for drug promotion were used to analysis of all obtained DPLs. Results: Among 300 DPLs, 251 were included for analysis as per inclusion criteria. Out of 251 DPLs, drugs acting on cardiovascular system (61) were promoted most followed by drugs acting on endocrine system (45), antimicrobial (39), and gastrointestinal tract system (33). Majority of brochures were providing information regarding brand name (249), dosage form (231), uses (225), and dose information (207). Very few literatures mentioned details such as side effects, warning, contraindications, precautions, and interactions. Average 2.91 claims were made for per each DPLs. Out of 83 references, majority of references were from journal articles. Very few DPLs have data that are displayed in scientific figures and tables. Among analyzed DPLs, majority them contain various pictures of medicines, organ part, and women. Conclusion: Majority of DPL were not following ethical standard as per the WHO guidelines and their purpose seems like commercial gain.

A cross-sectional study on knowledge and perceptions of generic medicines among MBBS and nursing students at a tertiary care hospital in Maharashtra

Background: Access to health-care facilities and essential medicines still remains a worldwide problem, particularly in developing countries. Greater awareness among health-care professional regarding generic drugs may translate into the increased consumption of generic drugs and reduction in healthcare costs wild maintaining the safety efficacy and quality off health-care system. Aim and Objectives: This study was conducted to analyze the knowledge and perception of generic medicines among MBBS and Nursing students in a medical teaching institute. Materials and Methods: A questionnaire-based cross-sectional study was conducted among 260 students (172 MBBS, 88 Nursing course) in Government Medical College Jalgaon, to assess knowledge and attitude of students for generic medicines. Descriptive statistics and Kruskal–Wallis test were used to analyze the responses. Results: Most respondents from MBBS (86%) and nursing course (89%) agree to need more information about how bioequivalence test are conducted for generic medicine. Perception about branded medicines requiring high quality standards as compared to generic medicines was high in both courses’ students with 69.3% of nursing students and 43.6% of MBBS students having wrong perception. About 77.4% of MBBS students and 42% of nursing students responded positively to the statement about generic medicines being cheaper than branded drugs. Conclusion: Students from both the courses showed eagerness to have more information, were lacking in the knowledge, and had confused attitude toward generic medicines. Proper education and training may impart proper knowledge and change the attitude among students toward the generic medicines.

Knowledge, perception and acceptance of generic drugs in the general Lebanese population: A cross-sectional survey among adults.

Many governments encouraged generic use to enhance health equality and minimise health expenditure. The lack of knowledge and acceptance of generic medicines are the main barriers to their use. This study aimed to assess population knowledge and perception towards generic drugs, identify their primary sources of information and examine which variables are independently related to their acceptance. An observational cross-sectional study was performed targeting the Lebanese adult population. Overall, 385 patients participated in the study. Data were collected using a uniform survey from six public healthcare centres. The participants reported a distrust towards generic drugs; they either said that they were not as effective as the brand (36.9%), were of less quality than the brand (38.5%) or had more side effects than the brand (38.4%). Around 52% said they would never buy a generic drug, and two-thirds (68.6%) preferred using a brand drug over a generic one. After adjusting for socio-demographics, a high income (odds ratio (OR) = 3.7), knowing that brands and generics have the same active ingredients (OR = 2.28) and that brands and generics were equally effective (OR = 6.46) were the strongest independent predictors for the willingness to buy generic drugs. A lack of knowledge and misperceptions about generic drugs limited the use of generic drugs, and therefore must be addressed.

Impact of Drug Price Regulation on Patient Access to Medicines: A Systematic Review

This systematic review explored the multifaceted impact of drug price regulation on patient access to essential medicines. Recognizing the complexity of this relationship, the paper investigates the influence of various types of drug price regulation mechanisms, the disparities across different geographical regions and health-care systems, and the differential effects between branded and generic drugs. Our findings illustrate that the effects of drug price regulation are not universally uniform or predictable, but rather, they are highly context dependent. Direct price control measures can, on the one hand, improve accessibility through affordability; yet on the other hand, potentially disrupt drug supply. Indirect price control methods, such as reference pricing and value-based pricing, while designed to spur competition, can be hampered by administrative complexities and potentially stifle pharmaceutical innovation. Despite the pervasive use of drug price regulation, access to essential medicines remains disparate and inequitable, indicating a need for a comprehensive approach that includes health system reforms, improved health literacy, and greater collaboration between stakeholders. Future research should further investigate the enduring disparities in patient access to medicines, the long-term effects of various pricing mechanisms, and their interplay with the evolving pharmaceutical industry and health-care landscapes.

Patented Brand Drugs are Essential Facilities and Regulatory Compacts

Patented Brand Drugs are Essential Facilities and Regulatory Compacts

Medicine pricing agreement will double annual growth in cost of branded drugs sold to the NHS

Medicine pricing agreement will double annual growth in cost of branded drugs sold to the NHS

Comparative Study of Nutraceutical Products Authorization Requirements in Singapore, Malaysia & Cambodia

The high cost of branded name pharmaceuticals in the nutraceuticals sector is a problem in Asian countries such as Singapore, Malaysia, and Cambodia. Generic medications, which are less expensive and more competitive than branded drugs, play an important role in boosting drug access and lowering drug costs. The pharmaceutical market in Southeast Asia is rapidly expanding. There are ten countries in the Asian region. All countries have a comparable regulatory environment. However, the registration requirements and procedures differ from country to country throughout the Asian region. Despite the fact that ACTD is harmonized for all ten nations, various local criteria, such as administrative, technical, clinical, and non-clinical papers, GMP, and ICH standards vary by country. This review article will provide an overview of the drug registration regulations of nutraceuticals in three key player ASEAN member states such as Singapore, Malaysia & Cambodia.

PHARMACOECONOMICAL ASPECTS OF SELF-MEDICATION; A COMMUNITY PHARMACY SURVEY IN NORTHERN KERALA

Objectives: The main objectives of the study are to identify the socio-economic characteristics of lay persons who engage in self-medication activities, to determine the economic aspects of self-medication, to conduct cost minimization analysis, and to determine the consequences of self-medication. Methods: A cross-sectional survey was conducted in community pharmacies throughout Northern Kerala for a period of 6 months from April 2021 to September 2021. A total of 300 participants were selected through consecutive sampling. Results: 117 people were from upper middle class families based on Kuppuswamy’s scale. A majority of participants considered self-medication for economic benefits which confirmed that self-medication is closely related to the financial background of the respondents. The costs saved were measured by calculating the costs associated with hospital visits by them or family in the past 6 months for similar manifestations. During the study, the cost of branded drugs prescribed was determined as 70–1498.78% more than the generic versions. Hence, patients are spending much more on their treatment unaware about other alternative options. 117 participants experienced an adverse drug reaction after taking the medication, and 134 participants responded that their symptoms were not improving and 99 entrants had to visit the hospital who had an economic burden due to delay in detection of the disease. Conclusion: Thus, the study concluded that there is a strong relationship between pharmacoeconomics and self-medication behavior.

Generics pros and cons

AbstractAlthough generic drugs have been replacing branded drugs for many years, but it is only required since 1992 that they have the same active and inactive ingredients.However, are generic drugs really the same as branded drugs? In systemically applied drugs, the amount of the active substance can be tested. In eye drops, however, we do not know the exact amount of the active substance which reaches the eye. Hence, the knowledge that the active substance is a small part of the whole drop and that the inactive parts may be changed in generic drugs lead to the conclusion that a generic eye drop may differ from the branded counterpart.The advantages of generic drops are mainly the costs: A new generic drug needs only the proof of the therapeutic equivalence or the pharmacokinetic bioequivalence and a sufficient compatibility, therefore it is much cheaper to produce a new generic drug than a branded drug.The disadvantages are manifold: The drop can vary in the inactive substances and therefore in the tolerability. The shape of the bottle, the tip of the bottle and the size of the opening of the tip can vary, leading to a considerable difference in number of drops in one bottle.Last but not least the patients may be sceptical about a generic drug, not knowing if it is as effective as the branded drug and having problems adapting to new shapes and colours of the bottles.Generic drugs have taken over a big part of the anti‐glaucomatous drug market. However, we need to inform the patients that there may be substantial differences between generic and branded drugs and check the patients more often after changing their medication.

Dynamics of price competition in Italian pharmaceutical off-patent market.

The aim of the study was to evaluate, in a regulated generics market, the effect of the number of manufacturers of generic drugs on the amplitude of off-patent products price reduction and the price evolution of originators and generics after the patent expiry of pharmaceuticals dispensed by community pharmacies and reimbursed by the Italian National Health Service (INHS). The AIFA "transparency list" was utilized to select unbranded and branded off-patent drug dispensed by community pharmacies and reimbursed by the Italian National Health Service between 2012 and 2018. The unbranded drug entry in the transparency list database was considered as a proxy of its patent expiry. A total of 42 different active ingredients were included in the analysis. The relative price per dose at time t of unbranded and branded drugs, considering as common denominator the price per dose a year before the patent expiry, (t-1) decreased with the increase of unbranded manufacturers. At the time of the patent expiry, the price of unbranded drugs was almost 50% less than that of branded drugs at t-1 and the price of branded drugs started to decrease before the first unbranded entry. An inverse relation between the number of generic drug entrants and the price of generics and originators was detected. The patent expiry determines a price decline, more concentrated in the first year of patent expiry.

An Analysis of Accessibility of Representative Psychotropic Medicine From the World Health Organization Model List of Essential Medicines in Developing Countries With Different Income Levels

ObjectivesThe objective of this study was to analyze the accessibility of psychotropic medicine in developing countries based on the availability, price, and affordability indicators to create international evidence to guide the development of policies on the accessibility of medicines. MethodsThis study included 5 types of psychotropic medicines listed in the 22nd edition of the World Health Organization Model List of Essential Medicines published by the World Health Organization in 2021. Derived from 84 surveys in 59 countries, this study summarizes the availability, price, and affordability of originator branded drugs (OBs) and lowest-price generic drugs (LPGs) in the public and private sectors and compares them based on income levels in different countries. ResultsThe average availability of psychotropic medicine was 45% in low- and lower-middle-income countries (LLMICs) compared with 49% in high- and upper-middle-income countries (HUMICs) whereas the availability of LPGs was higher than that of OBs in all country groups. The average patient price for OBs and LPGs was 94.0 and 23.2, respectively, and the overall patient price of psychotropic medicine in LLMICs was higher than that in HUMICs. The affordability of psychotropic medicine in LLMICs was lower than that in HUMICs. ConclusionsPsychotropic medicines in lower-middle-income countries have lower availability, a higher average patient price, and lower average affordability than in HUMICs, which requires lower-middle-income countries to take effective and various measures to improve the accessibility of psychotropic medicine.

Deregulation on branded and generic drugs price and its effect: a study of Chinese pharmaceutical market

PurposeThis research studies the effect of deregulation of price cap in pharmaceutical market. Price regulation (either through price cap or reference price) is common practice in the pharmaceutical market but recently there are increasing voices calling for deregulation claiming that deregulation could help in lowering drug price and increase revenue of pharmaceutical firms. Upon those callings, Chinese government removed the price cap regulation in June 2015. The author uses this natural policy experiment to study this effect.Design/methodology/approachIn this study, the author applied the interrupted time series analysis (ITSA) on the revenue data of nine categories of both generic and branded drugs in China from March 2011 to August 2016 (the time frame includes both before and after of the initialization of the deregulation) and analyzed the effect of deregulation.FindingsThe results showed that, whether the revenue of drugs will increase or decrease after the deregulation of price cap depends on the level of competition and the change of patterns of the branded and generic drugs are different. When HHI (Herfindahl–Hirschman index) is sufficiently low (competition is high), revenue does not change as a result of deregulation, when HHI is moderately low (moderate competition), revenue from generic drugs will decrease significantly and revenue from branded drugs will increase significantly, and when HHI is high (low competition), revenue from generic drugs will increase significantly and revenue from branded drugs will decrease significantly.Originality/valueThis is a unique study with a unique data set. Most previous studies focus on regulation of drug price and analyze how this may affect drug revenue; however, this is a natural policy experiment of de-regulation. Moreover, previously most studies focus on reference pricing regulation and this is price-cap, a different mechanism that is rarely studied. The originality/value is high of this article.

Effects of Medicare Part D coverage gap closure on utilization of branded and generic drugs.

The Affordable Care Act included a provision to gradually eliminate the Medicare prescription drug coverage gap between 2011 and 2020, which substantially lower medication costs in the gap. Using 2007-2016 Medicare claims data, we estimate how filling the gap affects individuals' out-of-pocket spending and medication use, separately for branded and generic drugs. One important difficulty in estimating the policy impact is that around the same time, many blockbuster drugs commonly used by the Medicare population experienced patent expiration and began to see generic entry. Because generic entries affected different therapeutic classes at different times, we run difference-in-differences models by therapeutic category at the beneficiary-month level to isolate the effect of the gap closure from that of generic entry. Overall, we find that filling the gap substantially reduced out-of-pocket spending and increased the use of branded drugs, which had larger discount rates during the analysis period. Beneficiaries reaching the gap, at older ages, or with comorbidities experienced larger reduction in out-of-pocket spending. We show that without accounting for generic entry, the effect of filling the coverage gap on medication use is underestimated for branded drugs and overestimated for generic drugs.

Modeling Tiered Pricing Frameworks: A Simulation Approach

Drug plans take different approaches to determining reimbursement prices for generic drugs. One common approach is to set the maximum reimbursement price as a percentage of the price of the interchangeable branded drug. In many countries this percentage depends on the number of generic entrants, a model we call "tiered pricing." This paper seeks to enhance understanding of how to set the tiers. We construct a simple model of tiered pricing and set parameters to match evidence on generic drug costs and the distribution of revenues. Using simulation methods, we then assess different tier structures in terms of total surplus and average drug cost. We find when tiers are bunched tightly together welfare outcomes are poor. Moreover, there are large welfare gains from increasing the number of tiers from one to two, and only small welfare gains from increasing the number of tiers beyond four. The choice of tiers has substantial welfare and cost implications. While it is possible to refine the simulation analysis based on specific market characteristics, an optimal tier structure, such as the one we propose in the paper, should have at least two tiers.

Pharmaceutical Evaluation of Acetaminophen Tablets Marketed in Duhok City-kurdistan

Tablets are the most frequently administered oral solid dosage form. The presence of various brands at varying costs from different companies requires verification to see whether they pass control tests and to determine which one is more effective and economical. Eight different brands were chosen, and their weight uniformity, hardness, friability, disintegration time, and drug content were tested. Then, prices were compared to quality to determine which brand was more effective and economical. All brands selected pass the United States Pharmacopeia (USP) tests for weight variation, friability, and disintegration time. Maximum weight variation was expressed by brand C, whereas brand A expressed the minimum. Brand E has the highest friability, while brand D has the lowest. The maximum disintegration time expressed is by brands E and G, while the minimum is expressed by brands B, D, F, and H. All the selected brands have enough hardness to withstand handling and manufacturing processes, except brand A, C, and G shows hardness somewhat outside the acceptable range, but this did not affect their disintegration time. According to USP, only two brands (A and H) pass the drug content test, with brand H having the maximum drug content and brand E the minimum. A and H were determined to be the most cost-effective brands based on a correlation between quality and prices

Trends in brand and generic drug utilization for dermatology providers from 2013-2019.

Prescription drug costs have risen considerably in the United States and are projected to reach $560 billion by 2028. To evaluate brand and generic drug utilization and cost proportions within Medicare Part D. Prescription data for dermatology providers were obtained from the Centers for Medicare and Medicaid Services 2013-2019 Medicare Part D Prescribers by Provider datasets. Percentage of brand vs. generic drug claims and costs and cumulative annual growth rates (CAGRs) were calculated. For the most recent year of data (2019), we conducted additional sub-analyses for calculated percentages by prescriber variables. The proportion of brand drug claims increased from 7.4% (in 2013) to 10.5% (2019) with a CAGR of 8.66%. In comparison, generic drug claims increased at a lower rate (CAGR 4.47%). The percentage of brand drug costs increased from 27.5% (in 2013) to 75.1% (2019). Inability to assess and generalize data for prescription patterns under non-Medicare plans. Our study demonstrates a disproportionate rise in dermatologic brand drug claims and a substantial increase in costs associated with brand drugs. Brand-name drugs are associated with higher out-of-pocket expenses for patients, which can lead to decreased access and adherence to treatment.