Generic medicines are introduced to the market after the expiry of the patented innovator medicine. Being usually sold at lower prices compared to branded medicines, they may provide a low-cost alternative for consumers. In Malaysia, where there is no Medicines Price Control Policy, it is not known if pharmacy profits differ between generic and branded medicines. It is also not known if this difference may affect pharmacists practice of generic substitution.
To develop and validate questionnaire to evaluate the perception of Malaysian community pharmacists toward the impact of generic substitution on community pharmacies’ profits.
Community pharmacies in 9 out of the 12 Malaysian states including Pahang, Kelantan, Melaka, Perak, Negeri Sembilan, Pulau Pinang, Selangor, Terengganu, and Sarawak.
A cross-sectional descriptive study was conducted using a newly developed questionnaire. A convenient sample of 99 community pharmacists was surveyed using this questionnaire.
The Cronbach’s alpha value for all of the statements in theme 2 of the questionnaire is 0.706, which lies in an acceptable range. It is found that generic medicines constituted 41–60% of merchandise in 41 of the surveyed pharmacies. Of the respondents, 72.9% stated recommending generic more than branded medicines and 89.9% of them reported that customers accepted their recommendations. Community pharmacists agreed that generic substitution results in financial benefits to community pharmacies. This can be found as most of the pharmacists agree that generic medicines lower whole sale price results in merchandise cost reduction, increase in pharmacy profit, higher profit margin, increase in pharmacy sales, and rate of return and reduction in community pharmacies capital. The maximum profit margin obtained with generic medicine is >100%, whereas for branded medicine, it is 81–100%.
Generic medicines are actively dispensed by community pharmacists and result in higher profit margin than innovator medicines.
Optimal product portfolio management is increasingly important for generic pharmaceutical companies in today’s intensely competitive environment. Strategic focus and front-level risk management are imperative for ensuring maximum value. This article addresses the key considerations and risks for ensuring a successful portfolio in a dynamic pharmaceutical landscape.
As gatekeepers in health continuum, physicians play a pivotal role in persuading patients to consume a specific medicine, and their prescription behavior has a great effect on both healthcare costs and pharmaceutical markets. Taking the important role of physicians in healthcare system into account, in this study we have tried to empirically prioritize those factors that affect physicians’ loyalty behavior in prescribing branded medicines.
This research is grounded on a survey through which 437 specialist physicians were randomly invited to fill out the questionnaire of the survey. Structural Equation Modeling was performed to evaluate the research model and to test the research hypotheses. In addition to demographic section, six measures were used to evaluate the prescription behavior of physicians in terms of loyalty.
The results revealed that there are some factors influencing physicians’ loyalty to branded medicines, among which professional influence is perceived to be the most important factor as compared with others. In contrast, the results rejected this hypothesis that promotional tools such as tangible rewards have a significant effect on physicians’ loyalty behavior.
The results contribute to the pharmaceutical companies endeavoring to develop fair, ethical, and effective marketing strategies to increase physicians’ loyalty to their products. Furthermore, by comparing the results of similar studies, this research has shed light on this fact that influencing factors on brand loyalty may be different across countries over the world.
The physicochemical qualities and ingestibility of high value-added amlodipine besilate formulations were evaluated using one brand name and four generic orally disintegrating tablets (formulations A, B, C, D, and E) and a generic orally disintegrating film (formulation F).
Pushing out from a press-through package, tablet strength, and hydrophilia were examined for the aforementioned formulations A–E, and sensory characteristics according to the disintegration time, taste, and palatability in healthy subjects were evaluated for formulations A–F.
The strength required for pushing out from a press-through package for formulations A, B, C, D, and E was approximately 20 N, indicating ease of opening for most users. Moreover, hardness and friability of formulations A, B, C, D, and E were more than 0.03 kg/mg and less than 1%, respectively. Thus, all formulations had sufficient tablet strength to endure fall impact in the automatic packing machine and vibration when carrying them from one place to another. The wetting time of formulation E (9 s) was significantly shorter than that of formulations A (27 s), B (34 s), C (28 s), and D (29 s), indicating that with the exception of hydrophilia, the physicochemical qualities of the five aforementioned formulations of orally disintegrating tablets were equivalent. The disintegration time of formulations E (15 s) and F (15 s) in the oral cavity was significantly shorter than that of formulations A (23 s), B (26 s), C (25 s), and D (22 s). Moreover, more than 50% of subjects reported strong or weak bitterness for formulations B, C, D, E, and F. Finally, more than 80% of subjects described formulations A, E, and F as easy to take, indicating good palatability.
This study provides useful information for selecting high value-added amlodipine besilate formulations for individualized treatments.
Here we examined the physical properties of one branded and five generic lansoprazole orally disintegrating tablets (formulations A and B, C, D, E, and F, respectively), including their hydrophilia and tablet strength and the strength required to push the tablets out of a press through package. The wetting time of formulation F (38 ± 4 s) was approximately 1.5–2.7 fold of that of formulations A, B, C, D, and E (25 ± 2, 14 ± 1, 14 ± 1, 16 ± 1, and 22 ± 1 s, respectively). Formulations B, C, D, E, and F had hardness (>3 kgf) and friability (<1%) that could endure impact and vibration of the manufacturing process and transporting. However, formulation A did not have enough tablet strength. The press through package pushing out strength of formulation C (34.4 ± 3.0 N) was approximately 1.2–1.7 fold of that of formulations A, B, D, E, and F (20.1 ± 1.8, 29.7 ± 1.3, 28.0 ± 1.8, 22.3 ± 2.3, and 24.2 ± 2.1 N, respectively). These findings indicate that the physical properties of lansoprazole orally disintegrating tablets, such as their hydrophilia, tablet strength, and press through package pushing out strength, differ between formulations. This study provides useful information for selecting lansoprazole orally disintegrating tablets individually suitable for each patient.
Canadian drug plan pricing of generic drugs is in a state of flux, with different plans adopting different approaches. The manner in which public plans pay for generic drugs can affect five policy goals: low generic drug prices, security of the drug supply, a reliance on reimbursement rules (thereby avoiding the need for drug plan managers to exercise discretion over reimbursement levels), low administrative burden and finally, the provision of adequate incentives for generics to enter the market. We review five pricing mechanisms: maximum prices, tiered pricing, tendering, benchmarking and pharmacy competition. We examine international evidence on the success of the first three of these. We conclude with an assessment of promising reimbursement approaches.
Today's trade agreements reflect in great measure the prevalence of special interests some of which, as in the case of originator pharmaceutical companies, seek to fence off their products from competition. This results in high prices that hinder the generic/biosimilar industry, which faces additional delays in the launch of its products, as well as consumers who are forced to pay higher prices for longer periods of time. The Trans Pacific Partnership (TPP) has become a key example of how powerful economic groups are striving to get countries to adopt regulations that would benefit them at the expense of everybody else. This is particularly clear in the case of biologic drugs, the most expensive drugs in today's market. Since their first patents have begun to expire, patent holders have been aggressively seeking to expand their rights and obtain additional protection through different means such as the adoption of long periods of exclusivity for data. If TPP negotiating parties end up yielding to the pressure, they would be endorsing a system that would simply not be sustainable.
In current scenario of innovative products, some of the products which hold a premier stand are those that combine, in some combination or others, elements of drugs, devices, and biologics. Drug-device combination products introduced a new change in medical product development, regulatory approval, and industrial interaction that provide valuable lessons for the development of new generations of medical products. These cutting-edge technologies have yielded the products to deliver drugs and biologics to specific targets within the body. In this paper, an introduction is given about combination products, their usefulness in the current drug delivery technologies, challenges in their regulation along with a brief history of these products, and overview of their regulatory status in major pharmaceutical jurisdictions. A brief review on regulatory path for their approval in various countries with special focus on drug device combinations along with the challenges faced by industries regarding their market approval is also given. For their market approval, the role and responsibilities of regulatory authority are addressed along with a brief description on review steps taken by Food and Drug Administration.
In Pozen Inc. v. Par Pharmaceutical, Inc., 696 F.3d 1151 (Fed. Cir. 2012), the Federal Circuit addressed the application of the doctrine of equivalents to ‘fuzzy’ claim limitations – i.e., claim limitations without set boundaries. The Federal Circuit found that even when the District Court has construed such limitations to have a definite meaning, the application of the doctrine of equivalents is not precluded. This case report presents the arguments made to the Federal Circuit by the parties and how the Federal Circuit addressed these issues.
In 2011, the Irish State spent 1.9bn on pharmaceuticals, amounting to approximately 13% of total public health expenditure. Over the period 2000–2010, Ireland experienced one of the fastest growth rates in per capita pharmaceutical expenditure in the OECD. Concern over pharmaceutical expenditure in Ireland has led to a number of policy changes, targeting primarily the price of pharmaceuticals. More recently, there has been much concern over the low rates of generic usage in Ireland. In 2009, 34% of multiple-source off-patent pharmaceuticals dispensed under the main State pharmaceutical reimbursement schemes in Ireland were generics, in comparison with 71% in the UK. Up to now, the potential for significant savings through the increased use of generics in Ireland has been limited as the price of off-patent pharmaceuticals (including generic pharmaceuticals) was set at a small discount to the patent-holder price. Legislation to introduce a system of reference pricing and generic substitution for 20 leading off-patent pharmaceuticals has recently been enacted. However, reference prices have yet to be set, and so the full scale of any potential savings under the Health (Pricing and Supply of Medical Goods) Act 2013 has yet to be determined. In advance of the new legislation, there has been evidence of a substantial increase in the use of generics in Ireland, although the precise reasons driving this increase are unclear.
Compulsory licensing of drug products is a very hot issue in today’s pharmaceutical world. Compulsory licensing of a drug product allows the government to issue the license of manufacturing the drug to a third person. The third person has to give some 5–10% royalty to the patent holder (the quantum of royalty is decided by the government and not by the patentee). The issue emerged after developing nations were given TRIPS flexibilities to implement the system when lives of large population are at stake. Compulsory licenses have been given in many countries like Thailand, Brazil, Mozambique, Zimbabwe, Zambia, Rwanda, Malaysia, Indonesia and recently India. India issued compulsory license over Bayer’s anticancer drug Naxaver (Sorafenib) to generic company Natco Pharma Ltd. United States has criticized the Indian decision. United States has also put Thailand on watch list after Thailand has issued compulsory licenses to three antiretroviral drugs. Compulsory licensing of drug products is very beneficial for the patients but is considered a big threat for the pharmaceutical companies. The branded drug makers spend billion dollars to patent a drug product. It is claimed by the pharmaceutical majors that the royalty of 5–10% given by generic drug makers to these companies is not enough to recoup their loss. The present article explores the utilization of "Compulsory Licensing" by several countries, exemplified by India and Brazil in particular, and highlights the patentees’ concerns of losing profits. The authors have attempted to negate the concern of the patentees over the use of compulsory licensing.
A number of decisions have already been handed down this year by the Australian Federal Court in a series of pharmaceutical patent challenges. The most recent of them is the decision in the esomeprazole case. At issue was the validity and infringement of three patents:
1. the so-called purity patent claiming an optically pure salt of the (–)- enantiomer of omeprazole, including the magnesium salt;
2. the so-called multiple unit tableted dosage form patent claiming, amongst other things, omeprazole or one of its single enantiomers or an alkaline salt thereof in a tablet form with defined characteristics; and
3. the so-called 774 patent claiming an oral pharmaceutical dosage form comprising, amongst other things, a proton pump inhibitor including omeprazole or the (–)- enantiomer of omeprazole.
This case is another example of the Federal Court complying with the parties’ express desire for a prompt delivery of reasons for judgement. After a hearing of some weeks, which concluded on 28 March 2013, there were final written submissions filed on 12 April 2013. The parties (and in particular Ranbaxy) requested a determination preferably by no later than 23 April 2013. That gave Justice Middleton just under one month from the conclusion of the hearing and only 10 days after the final written submissions to deliver a judgement with respect to the validity of three separate patents, each of which was attacked on numerous bases including lack of novelty, a lack of inventive step and manner of manufacture. His Honour’s judgement extends to 1017 separate paragraphs over 148 pages. Although the decision does not traverse any astoundingly new ground or offer any particularly insightful new approach to the conventional validity attacks that were mounted, some general observations may be of interest.
The aim of this study was to explore Jordanian pharmacists’ perceptions towards generic medicines as well as to evaluate their opinions on generic substitution in order to introduce a future generic substitution policy in Jordan. A cross-sectional descriptive study involving community pharmacists in Amman-Jordan was undertaken, using a self-completed anonymous questionnaire. The sampling unit was community pharmacy, and the sampling frame was list of community pharmacies in Amman (N = 1252). Five hundred pharmacies were randomly selected to participate in this survey, and 294 pharmacists’ responses were collected giving a response rate of 58.8%. The majority of Jordanian pharmacists had a positive view on generic medicines in general with 87.7% of the respondents believing that a generic medicine is bio-equivalents to the originator. Two hundred and sixty-five pharmacists (90.1%) were in favour of implementing a compulsory generic prescribing policy. More than 80% of the pharmacists supported generic substitution in most cases. Generic substitution policy should be implemented; in addition, a formulary of interchangeable medicines must be developed to guide pharmacists’ decision making when performing generic substitution. Jordanian pharmacists were also in favour of introducing a compulsory generic prescribing legislation; however, such policy may have a negative impact on the local industry, as most of the produced medicines are branded generics.