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FDA Orange Book · active-ingredient family

Methenamine hippurate

Methenamine hippurate is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HIPREX · NDA 017681

2

Brand (NDA)

6

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
HIPREXRLDESJAY PHARMANDA 017681ABApproved Prior to Jan 1, 1982
UREXQUAGENNDA 016151ABApproved Prior to Jan 1, 1982

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
METHENAMINE HIPPURATEZYDUS LIFESCIENCESANDA 219661ABMar 10, 2025
METHENAMINE HIPPURATEJUBILANT CADISTAANDA 217675ABDec 01, 2023
METHENAMINE HIPPURATEINGENUS PHARMS LLCANDA 210068ABNov 27, 2020
METHENAMINE HIPPURATEMICRO LABSANDA 212172ABAug 01, 2019
METHENAMINE HIPPURATEAUROBINDO PHARMA LTDANDA 205661ABJul 05, 2016
METHENAMINE HIPPURATEIMPAX LABS INCANDA 076411—Jun 20, 2003

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Methenamine hippurate — frequently asked questions

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

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