The history of a transdermal product: From innovation to generic

[Display omitted] The development, registration and successful launch of a novel, innovative transdermal pharmaceutical product requires an idea, structured planning and a highly skilled, specialist team. It is not often that the opportunity arises to document this activity. This paper demonstrates...

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Bibliographic Details
Published in:International journal of pharmaceutics 2022-05, Vol.619, p.121692-121692, Article 121692
Main Authors: Watkinson, A.C., Colagrande, F.
Format: Article
Language:English
Subjects:
Administration, Cutaneous
Axiron
Drug development
Drug Industry
Drugs, Generic
Humans
Testosterone
Transdermal delivery
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Summary:[Display omitted] The development, registration and successful launch of a novel, innovative transdermal pharmaceutical product requires an idea, structured planning and a highly skilled, specialist team. It is not often that the opportunity arises to document this activity. This paper demonstrates the multidisciplinary effort required to take such a product (Axiron®, a transdermal testosterone product) from innovation to market and also describes its ultimate fate after the generic drug industry took an interest in its commercial success. Although many understand various aspects of this drug development process this understanding is often, by necessity, limited to the specialities of each of the individuals involved. It is hoped that this paper will provide an interesting overview of the entire process from beginning (innovation) to end (genericization).
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2022.121692