Viewing data from:

METHENAMINE HIPPURATE

ANDA

METHENAMINE HIPPURATE | A076411 | IMPAX LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Athyna Pharma LLC FDA-2025-P-5272 Athyna Pharma LLC filed this suitability petition requesting that the FDA declare Buprenorphine Hydrochloride and Naloxone Hydrochloride sublingual tablets in three new strengths (1.4 mg, 2.9 mg, and 5.7 mg) suitable for submission in an Abbreviated New Drug Application, referencing Indivior's appro	Suitability	2025-10-17	Open	Athyna Pharma LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Medicare Part D Spending

CMS annual spending data for Methenamine Hippurate (2023)

Total Spending

$62.1M

Total Claims

706,500

Beneficiaries

161,162

Avg Cost/Unit

$1.13

Spending Trend

$44.3M(2019)→$50.1M(2020)→$54.1M(2021)→$58.2M(2022)→$62.1M(2023)

YoY Change:-10.6%

5yr CAGR:-4.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs5 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED EVIONNAZ SAMETHENAMINE HIPPURATE

DMF 73331988

APITORIA PHARMA PRIVATE LTDMETHENAMINE HIPPURATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 270212013

CHEMISCHE FABRIK BERG GMBHMETHENAMINE HIPPURATE

DMF 281202014

MICRO LABS LTDMETHENAMINE HIPPURATE USP

DMF 319882017

KREATIVE ORGANICS PRIVATE LTDMETHENAMINE HIPPURATE USP

DMF 346802020

SS PHARMA LLCMETHENAMINE HIPPURATE

DMF 400572024

KALINTIS HEALTHCARE PVT LTDMETHENAMINE HIPPURATE USP

DMF 403672025

JT BAKER CHEMICAL COInactiveMETHENAMINE HIPPURATE

DMF 49491983

JAME FINE CHEMICALS INCInactiveMETHENAMINE HIPPURATE

DMF 50181983

3M PHARMACEUTICALSInactiveMETHENAMINE HIPPURATE

DMF 71001987

CHEMISCHE FABRIK BERG GMBHInactiveMETHENAMINE HIPPURATE

DMF 75231988

SAI LIFE SCIENCES LTDInactiveMETHENAMINE HIPPURATE USP

DMF 290582015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 1GM

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 20, 2003

No patent or exclusivity listings for this strength.