Pharmaceutical Lifecycle Extension Strategies

Kappe, Eelco

doi:10.1007/978-1-4614-7801-0_8

Cited by 5 publications

(8 citation statements)

References 60 publications

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“…Improvements are made by making the drug more convenient to use by the patients and by reducing its side effects. 12 A large percentage of newly approved drugs are mere new formulations of existing drugs. The cost and effort involved in introducing reformulations are considerably low as compared to the cost of developing and introducing a novel drug.…”

Section: Patents For New Formulations or New Compositionsmentioning

confidence: 99%

“…The cost and effort involved in introducing reformulations are considerably low as compared to the cost of developing and introducing a novel drug. 12 Marketing or promotional cost of new formulations is also low because they build on the brand-name of already patented and marketed drug. 12…”

Section: Patents For New Formulations or New Compositionsmentioning

confidence: 99%

“…12 Marketing or promotional cost of new formulations is also low because they build on the brand-name of already patented and marketed drug. 12…”

Section: Patents For New Formulations or New Compositionsmentioning

confidence: 99%

“…Combining two or more active ingredients, that are already existing as single entities, to make a new combination drug is also a tactic employed by drug manufacturers to extend market exclusivity. 12 Two or more already known active ingredients are combined chemically or physically to make a new combination drug as a result of product bundling. 12 For instance, Zidovudine, HIV drug, was first developed in 1964 by Glaxo Wellcome (which later merged with SmithKline Beecham to form Glaxo SmithKline or GSK) and it was granted a patent in 1984.…”

Section: Patents For New Combinations Of Drugsmentioning

confidence: 99%

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Evergreening of pharmaceutical patents: A blithe disregard for the rationale of the patent system

Abbas

2019

Journal of Generic Medicines

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Evergreening of pharmaceutical patents has emerged as a serious challenge for access to affordable drugs as it aims to delay the generic competition by extending the length of the exclusivity period beyond the legitimate patent term without any considerable improvement in therapeutic benefits of the already patented pharmaceutical drug. This paper endeavours to question the legitimacy of the evergreening of pharmaceutical patents. This study applies all the recognized theories in support of the patent system-namely the 'natural law' or 'natural rights' theory, the 'reward by monopoly' theory, the 'monopoly-profit incentive' theory, the 'exchange for secrets' theory or the 'contract' theory, and the 'prospect' theory-to the practice of evergreening of drug patents in order to check whether or not any of these theories can be used to justify the practice. The study concludes that the practice of evergreening is not consistent with any of these theories and therefore lacks any plausible justification.

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Section: Patents For New Formulations or New Compositionsmentioning

confidence: 99%

Section: Patents For New Formulations or New Compositionsmentioning

confidence: 99%

“…12 Marketing or promotional cost of new formulations is also low because they build on the brand-name of already patented and marketed drug. 12…”

Section: Patents For New Formulations or New Compositionsmentioning

confidence: 99%

Section: Patents For New Combinations Of Drugsmentioning

confidence: 99%

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Evergreening of pharmaceutical patents: A blithe disregard for the rationale of the patent system

Abbas

2019

Journal of Generic Medicines

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“…Generic Entry The current study investigates the role of information content as the category undergoes competitive entry, such as branded and generic entry, which are two major competitive events in a drug's life cycle (Berndt et al 2003, Kappe 2014, Narayanan and Manchanda 2009).…”

Section: Competitive Response To Branded Andmentioning

confidence: 99%

Drug Detailing and Doctors’ Prescription Decisions: The Role of Information Content in the Face of Competitive Entry

Kappe

Stremersch

2016

Marketing Science

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W e study the effects of information content in 59,814 pharmaceutical sales calls on doctors' prescription decisions for statins, in the face of entry of competing brands and generics, using a hierarchical Bayesian distributed lag model. We conclude that adding information content to the prescription response model improves the in-and out-of-sample performance of the model. In the first six months following generic entry, it is more effective for incumbent brands to detail on drug contraindications and indications, compared to other periods, to positively differentiate from generics. In the first six months following branded entry, it is less effective for incumbent brands to detail on drug indications and costs, given increased competitive clutter. We also document substantial heterogeneity among doctors in their response to information content. Our model is helpful for analysts to more accurately assess the effectiveness of detailing. Our empirical results are also informative for drug manufacturers as they set or change their messaging policies in response to entry and help firms to tailor their message content at the doctor level.

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