The Evergreening of Biopharmaceuticals: Time to Defoliate

Lehmann, David F.; Wojnowicz, Sarabeth

doi:10.1002/jcph.642

Cited by 3 publications

(3 citation statements)

References 44 publications

(109 reference statements)

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“…Given that omeprazole and esomeprazole have the same chemical structure and do not present pharmacodynamic differences, the company justifi ed the development of the enantiopure exclusively on pharmacokinetic differences, particularly a difference in the affi nity for CYP2C19, an enzyme belonging to the large hepatic enzyme complex of cytochrome P450, whose basic function is to transform its substrates into more polar and soluble molecules, thus facilitating their excretion. This would result in esomeprazole remaining active for a longer period than omeprazole [6].…”

Section: Clinical Aspectsmentioning

confidence: 99%

“…A 2013 study [6] of the US market calculated the price difference between an equipotent dose of these two drugs for six-weeks of treatment and found that patients using esomeprazole spent US$ 111 more that those using omeprozale. It is estimated in just a year, AstraZeneca generated an additional US$1.5 million from this chiral switch.…”

Section: Commercial Aspectsmentioning

confidence: 99%

“…The term 'evergreening' refers to the use of legal, commercial and technological strategies to extend due-to-expire patents of successful products [6][7][8]. Big Pharma companies have used evergreening to prolong their legal monopoly, enabling the patent owner to maintain high prices and avoid losing the commercial benefi ts that would likely result from the commercialization of generic versions of their branded products [9,10].…”

Section: Introductionmentioning

confidence: 99%

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A case study of AstraZeneca’s omeprazole/esomeprazole chiral switch strategy

Piñeiro,

Rogelio Alberto

2022

GaBI J

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Introduction/Objective: To describe the chiral switch, an evergreening strategy used by AstraZeneca to position enantiopure esomeprazole as the new proton pump inhibitor market leader, displacing its predecessor omeprazole. Methodology: A four-stage systematic review which included: a preliminary review, bibliographic review using databases, classification of the body of literature, and content analysis. Results: Using different legal and commercial strategies, such as patent thickets and aggressive publicity campaigns, AstraZeneca transferred consumer loyalty from their successful omeprazole to esomeprazole, its new and more expensive patent protected product which has the same therapeutic value as its predecessor. This chiral switch allowed AstraZeneca to maintain monopoly prices, which increased the financial burden experienced by consumers and payors and may have also had a negative impact on access to the medication. Conclusions: This case study exemplifies how the current patent system, including patent thickets, can be used to enhance the profits of pharmaceutical companies while stalling innovation and placing undue financial burdens on the consumer.

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Section: Clinical Aspectsmentioning

confidence: 99%

Section: Commercial Aspectsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A case study of AstraZeneca’s omeprazole/esomeprazole chiral switch strategy

Piñeiro,

Rogelio Alberto

2022

GaBI J

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Lifetime evolution of ADHD treatment

et al. 2021

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ADHD with Comorbid Bipolar Disorders: A Systematic Review of Neurobiological, Clinical and Pharmacological Aspects Across the Lifespan

Mucci

Avella

Marazziti

2019

CMC

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Background: Attention deficit hyperactivity (ADHD) disorder is a neurodevelopmental disorder characterized by inattention, hyperactivity, disruptive behaviour, and impulsivity. Despite considered typical of children for a long time, the persistence of ADHD symptoms in adulthood gained increasing interest during the last decades. Indeed, its diagnosis, albeit controversial, is rarely carried out even because ADHD is often comorbid with several other psychiatric diosrders, in particular with bipolar disorders (BDs), a condition that complicates the clinical picture, assessment and treatment. Aims: The aim of this paper was to systematically review the scientific literature on the neurobiological, clinical features and current pharmacological management of ADHD comorbid with BDs across the entire lifespan, with a major focus on the adulthood. Discussion: The pharmacology of ADHD-BD in adults is still empirical and influenced by the individual experience of the clinicians. Stimulants are endowed of a prompt efficacy and safety, whilst non-stimulants are useful when a substance abuse history is detected, although they require some weeks in order to be fully effective. In any case, an in-depth diagnostic and clinical evaluation of the single individual is mandatory. Conclusions: The comorbidity of ADHD with BD is still a controversial matter, as it is the notion of adult ADHD as a distinct nosological category. Indeed, some findings highlighted the presence of common neurobiological mechanisms and overlapping clinical features, although disagreement does exist. In any case, while expecting to disentangle this crucial question, a correct management of this comorbidity is essential, which requires the co-administration of mood stabilizers. Further controlled clinical studies in large samples of adult ADHD-BD patients appear extremely urgent in order to better define possible therapeutic guidelines, as well as alternative approaches for this potentially invalidating condition.

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The Evergreening of Biopharmaceuticals: Time to Defoliate

Cited by 3 publications

References 44 publications

A case study of AstraZeneca’s omeprazole/esomeprazole chiral switch strategy

A case study of AstraZeneca’s omeprazole/esomeprazole chiral switch strategy

Lifetime evolution of ADHD treatment

ADHD with Comorbid Bipolar Disorders: A Systematic Review of Neurobiological, Clinical and Pharmacological Aspects Across the Lifespan

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