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FDA Orange Book · active-ingredient family

Paroxetine mesylate

Paroxetine mesylate is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BRISDELLE · NDA 204516

2

Brand (NDA)

2

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
BRISDELLERLDLEGACY PHARMANDA 204516ABJun 28, 2013
PEXEVARLD×4SEBELA IRELAND LTDNDA 021299—Jul 03, 2003

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
PAROXETINE MESYLATEPRINSTON INCANDA 207188ABAug 18, 2017
PAROXETINE MESYLATEACTAVIS LABS FL INCANDA 207139ABJun 20, 2017

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8946251Aug 04, 2026in 2 mo
SubstanceProductU-904
9393237Aug 04, 2026in 2 mo
U-904
8658663Apr 06, 2029in 2 yr 10 mo
SubstanceProductU-904

Paroxetine mesylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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