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Orphan drug: Development trends and strategies

The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic...

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Detalles Bibliográficos
Autores principales: Sharma, Aarti, Jacob, Abraham, Tandon, Manas, Kumar, Dushyant
Formato: Texto
Lenguaje:English
Publicado: Medknow Publications 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2996062/
https://www.ncbi.nlm.nih.gov/pubmed/21180460
http://dx.doi.org/10.4103/0975-7406.72128
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author Sharma, Aarti
Jacob, Abraham
Tandon, Manas
Kumar, Dushyant
author_facet Sharma, Aarti
Jacob, Abraham
Tandon, Manas
Kumar, Dushyant
author_sort Sharma, Aarti
collection PubMed
description The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model — niche busters, also called orphan drugs. Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols, are a further boost for the companies developing orphan drugs. Although there may still be challenges ahead for the pharmaceutical industry, orphan drugs seem to offer the key to recovery and stability within the market. In our study, we have compared the policies and orphan drug incentives worldwide alongwith the challenges faced by the pharmaceutical companies. Recent developments are seen in orphan drug approval, the various drugs in orphan drug pipeline, and the future prospectives for orphan drugs and diseases.
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spelling pubmed-29960622010-12-21 Orphan drug: Development trends and strategies Sharma, Aarti Jacob, Abraham Tandon, Manas Kumar, Dushyant J Pharm Bioallied Sci Invited Review The growth of pharma industries has slowed in recent years because of various reasons such as patent expiries, generic competition, drying pipelines, and increasingly stringent regulatory guidelines. Many blockbuster drugs will loose their exclusivity in next 5 years. Therefore, the current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies from the essential medicines to the new business model — niche busters, also called orphan drugs. Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs. The new business model of orphan drugs could offer an integrated healthcare solution that enables pharma companies to develop newer areas of therapeutics, diagnosis, treatment, monitoring, and patient support. Incentives for drug development provided by governments, as well as support from the FDA and EU Commission in special protocols, are a further boost for the companies developing orphan drugs. Although there may still be challenges ahead for the pharmaceutical industry, orphan drugs seem to offer the key to recovery and stability within the market. In our study, we have compared the policies and orphan drug incentives worldwide alongwith the challenges faced by the pharmaceutical companies. Recent developments are seen in orphan drug approval, the various drugs in orphan drug pipeline, and the future prospectives for orphan drugs and diseases. Medknow Publications 2010 /pmc/articles/PMC2996062/ /pubmed/21180460 http://dx.doi.org/10.4103/0975-7406.72128 Text en © Journal of Pharmacy and Bioallied Sciences http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Invited Review
Sharma, Aarti
Jacob, Abraham
Tandon, Manas
Kumar, Dushyant
Orphan drug: Development trends and strategies
title Orphan drug: Development trends and strategies
title_full Orphan drug: Development trends and strategies
title_fullStr Orphan drug: Development trends and strategies
title_full_unstemmed Orphan drug: Development trends and strategies
title_short Orphan drug: Development trends and strategies
title_sort orphan drug: development trends and strategies
topic Invited Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2996062/
https://www.ncbi.nlm.nih.gov/pubmed/21180460
http://dx.doi.org/10.4103/0975-7406.72128
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