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. 2009 May-Jun;28(3):734-45.
doi: 10.1377/hlthaff.28.3.734.

Antidepressant reformulations: who uses them, and what are the benefits?

Haiden A Huskamp  1 , Alisa B Busch, Marisa E Domino, Sharon-Lise T Normand
Affiliations

Antidepressant reformulations: who uses them, and what are the benefits?

Haiden A Huskamp et al. Health Aff (Millwood). 2009 May-Jun.

Abstract

The Hatch-Waxman Act of 1984 provides pharmaceutical manufacturers with an incentive to introduce reformulations of existing products that are about to lose patent protection, to extend marketing exclusivity and maintain high prices. Antidepressant reformulations are particularly common. To determine whether the use of reformulations confers benefits, we examined who uses them and whether they affect the duration of medication use. We found some evidence of benefit for subgroups of antidepressant users, although benefits varied across reformulations.

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References

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    1. The original product’s patent is not extended. Additional exclusivity applies only to the reformulation. Most types of reformulations (e.g., controlled-release forms) would receive three years of exclusivity. Lexapro, marketed as a new chemical entity, received five.

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