Famotidine Patent Expiration

Famotidine was first introduced by Bausch Health Us Llc in its drug Pepcid on Oct 15, 1986. Other drugs containing Famotidine are Famotidine, Pepcid Rpd, Pepcid Ac, Fluxid, Pepcid Preservative Free In Plastic Container, Pepcid Preservative Free. 62 different companies have introduced drugs containing Famotidine.


Famotidine Patents

Given below is the list of patents protecting Famotidine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Pepcid Ac US6814978

(Pediatric)

Process for preparing a soft tablet Feb 26, 2022

(Expired)

Kenvue Brands
Pepcid Ac US6814978 Process for preparing a soft tablet Aug 26, 2021

(Expired)

Kenvue Brands
Fluxid US6024981 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

Ucb Inc
Fluxid US6221392 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

Ucb Inc
Pepcid Ac US5854267

(Pediatric)

Method for preventing heartburn Jun 29, 2016

(Expired)

J And J Consumer Inc
Pepcid Ac US5854267

(Pediatric)

Method for preventing heartburn Jun 29, 2016

(Expired)

Kenvue Brands
Pepcid Ac US5854267 Method for preventing heartburn Dec 29, 2015

(Expired)

J And J Consumer Inc
Pepcid Ac US5854267 Method for preventing heartburn Dec 29, 2015

(Expired)

Kenvue Brands
Pepcid Ac US5667794

(Pediatric)

Heartburn treatment Nov 02, 2015

(Expired)

Kenvue Brands
Pepcid Ac US5667794 Heartburn treatment May 02, 2015

(Expired)

Kenvue Brands



Famotidine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Famotidine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Antihistamines in the Treatment of Irritable Bowel Syndrome With Diarrhea University of Cincinnati NA WITHDRAWN
(Sep 1, 2026)
PHASE3
A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Antacid in Healthy Adults Pfizer NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib Nuvation Bio Inc. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19 Northwell Health NA COMPLETED
(Jun 1, 2026)
PHASE2
A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors Epkin NA RECRUITING
(Jun 1, 2026)
PHASE1
A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants Bristol-Myers Squibb NA COMPLETED
(May 1, 2026)
PHASE1


Famotidine Generic API Manufacturers

Several generic applications have been filed for Famotidine. The first generic version for Famotidine was by Watson Laboratories Inc and was approved on Apr 16, 2001. And the latest generic version is by Lupin Ltd and was approved on May 12, 2026.

Given below is the list of companies who have filed for Famotidine generic, along with the locations of their manufacturing plants worldwide.