Cetrorelix Acetate Patent Expiration

Cetrorelix Acetate is Used for preventing premature LH surges in women undergoing controlled ovarian stimulation. It was first introduced by Emd Serono Inc in its drug Cetrotide on Aug 11, 2000. 7 different companies have introduced drugs containing Cetrorelix Acetate.


Cetrorelix Acetate Patents

Given below is the list of patents protecting Cetrorelix Acetate, 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
Cetrotide US6319192 Method for the treatment of fertility disorders Apr 23, 2019

(Expired)

Emd Serono Inc
Cetrotide US6863891 Oligopeptide lyophilisate, their preparation and use Feb 22, 2014

(Expired)

Emd Serono Inc
Cetrotide US7605121 Oligopeptide lyophilisate, their preparation and use Feb 22, 2014

(Expired)

Emd Serono Inc



Cetrorelix Acetate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Cetrorelix Acetate:

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
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA) Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany NA RECRUITING
(Sep 1, 2026)
PHASE3
Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation Bedaya Hospital NA RECRUITING
(Apr 1, 2026)
PHASE2


Cetrorelix Acetate Generic API Manufacturers

Several generic applications have been filed for Cetrorelix Acetate. The first generic version for Cetrorelix Acetate was by Teva Pharmaceuticals Inc and was approved on Aug 12, 2022. And the latest generic version is by Epic Pharma Llc and was approved on Apr 29, 2026.

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