FDA Orange Book · active-ingredient family
Methenamine hippurate
Methenamine hippurate: 2 brands, 6 generics; first approved Jun 20, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
6
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
Generic (ANDA) products (6)
Abbreviated applications
- METHENAMINE HIPPURATEZYDUS LIFESCIENCESANDA 2196612025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - METHENAMINE HIPPURATEJUBILANT CADISTAANDA 2176752023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - METHENAMINE HIPPURATEINGENUS PHARMS LLCANDA 2100682020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - METHENAMINE HIPPURATEMICRO LABSANDA 2121722019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - METHENAMINE HIPPURATERSAUROBINDO PHARMA LTDANDA 2056612016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - METHENAMINE HIPPURATEIMPAX LABS INCANDA 0764112003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
23 yr 8 mo ago
Most recent approval
1 yr 7 mo ago
Approvals span 2003–2025 across 8 FDA applications.
Brand (NDA) 225%
Generic (ANDA) 675%
Methenamine hippurate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
