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Authorized Generics

Nature Reviews Drug Discovery volume 4, pages 953–955 (2005)Cite this article

However, some other companies, notably Novartis, AstraZeneca, Merck, Teva and Mylan, have so far been reluctant to enter into such an arrangement, because it represents a cooperative effort between bitter market rivals and a deviation from core business and product strategies. In addition, there was some concern within the market that these contractual arrangements might violate the Hatch?Waxman Act or even US antitrust laws. However, recent agency opinion and a court ruling have allayed these fears, marking an open pathway for brands and generics to enter into these partnerships. We can expect them to become part of the natural course of life-cycle management in the future.

Launching a generic drug

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References

  1. Court of Appeals for the District of Columbia, Case Number 05-5004 (June 3, 2005). http://pacer.cadc.uscourts.gov/docs/common/opinions/200506/05-5004a.pdf

  2. Chairman's Mark of the Deficit Reduction Omnibus Reconciliation Act of 2005 [online], <http://finance.senate.gov/sitepages/leg/102505chmkmod.pdf> (2005).

  3. Press release. Grassley, Senators Request study of impact of 'authorized' generics [online], http://grassley.senate.gov/index.cfm?FuseAction=PressReleases.Detail&PressRelease_id=4903&Month=5&Year=2005 (12 May 2005).

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Acknowledgements

The author would like to thank C. Worrell for his input into Table 1.

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  1. the Principal of Gregory Glass Associates LLC, Downingtown, 19335, Pennsylvania, USA

    Gregory Glass

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Glass, G. Authorized Generics. Nat Rev Drug Discov 4, 953–955 (2005). https://doi.org/10.1038/nrd1906

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