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FDA Orange Book · active-ingredient family

Phentermine hydrochloride; topiramate

Phentermine hydrochloride; topiramate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:QSYMIA · NDA 022580

1

Brand (NDA)

2

Generics (ANDA)

6

Listed patents

4

Exclusivity periods

Brand (NDA) products · capsule, extended release

ProductApplicantApplicationTEApproved
QSYMIARLD×4VIVUS LLCNDA 022580ABJul 17, 2012

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE×4DR REDDYS LABS SAANDA 208175ABJun 12, 2025
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE×4ACTAVIS LABS FL INCANDA 204982ABJun 25, 2024

Marketing exclusivity (4)

  • M-308New use / labeling-change exclusivity (3 years)

    Sep 13, 2027

    in 1 yr 3 mo

  • M-308New use / labeling-change exclusivity (3 years)

    Sep 13, 2027

    in 1 yr 3 mo

  • M-308New use / labeling-change exclusivity (3 years)

    Sep 13, 2027

    in 1 yr 3 mo

  • M-308New use / labeling-change exclusivity (3 years)

    Sep 13, 2027

    in 1 yr 3 mo

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9011906Jun 09, 2028in 2 yr
U-3398
8895057Jun 09, 2028in 2 yr
U-3398
8895058Jun 09, 2028in 2 yr
Product
9011905Jun 09, 2028in 2 yr
Product
8580298May 15, 2029in 2 yr 11 mo
Product
8580299Jun 14, 2029in 3 yr
U-3399

Phentermine hydrochloride; topiramate — frequently asked questions

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

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