Progesterone Patent Expiration

Progesterone is used for supporting embryo implantation and early pregnancy in infertile women undergoing assisted reproductive technology (ART) treatment. It was first introduced by Eli Lilly And Co in its drug Progesterone on Approved Prior to Jan 1, 1982. Other drugs containing Progesterone are Progestasert, Milprosa, Prometrium, Endometrin, Crinone. 19 different companies have introduced drugs containing Progesterone.


Progesterone Patents

Given below is the list of patents protecting Progesterone, 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
Milprosa US8580293 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof Jan 21, 2030 Ferring Pharms Inc
Milprosa US10537584 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof Feb 03, 2029 Ferring Pharms Inc
Milprosa US10548904 Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof Feb 03, 2029 Ferring Pharms Inc
Endometrin US7300664 Vaginally administrable progesterone-containing tablets and method for preparing same Nov 17, 2019

(Expired)

Ferring
Endometrin US7320800 Vaginally administrable progesterone-containing tablets and method for preparing same Nov 17, 2019

(Expired)

Ferring
Endometrin US7393543 Vaginally administratable progesterone-containing tablets and method for preparing same Nov 17, 2019

(Expired)

Ferring
Crinone US5543150 Method of progesterone delivery and affect thereof Sep 15, 2013

(Expired)

Abbvie



About Veterinary Progesterone

Progesterone is used in a drug marketed by 1 company: Zoetis Inc.

Other drugs containing Progesterone are: Eazi breed cidr sheep insert , Eazi breed cidr cattle insert .

Veterinary Progesterone Patents

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

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NEW
Drug Used In Drug Patent Number Drug Patent Expiry Drug Owner
Patent Data
EAZI BREED CIDR Sheep Insert US6663608 22 Jun, 2017 ZOETIS INC.
EAZI BREED CIDR Cattle Insert US6663608 22 Jun, 2017 ZOETIS INC.

Progesterone Petitions

Details of Progesterone's suitability petitions are listed below.

Petitioner Action Date of Action Description
Suitability Petitions
Bioniche Animal Health USA, Inc. Approved
Intervet, Inc. Approved

Progesterone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Progesterone:

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
The Investigation of Vitamin D and Menstrual Cycles Trial, the inVitD Trial: A Phase II Clinical Trial National Institute of Environmental Health Sciences (NIEHS) NA COMPLETED
(Sep 9, 2026)
PHASE2
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency Calla Lily Clinical Care Ltd NA RECRUITING
(Sep 1, 2026)
PHASE1
Mammogram Pretreatment With Ulipristal Acetate OHSU Knight Cancer Institute NA RECRUITING
(Sep 1, 2026)
PHASE2
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Miscarriages General University Hospital, Prague NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. IBSA Institut Biochimique SA NA COMPLETED
(Aug 1, 2026)
PHASE3
Biomarkers to Detect Endocrine Therapy Resistance University of Wisconsin, Madison NA RECRUITING
(Aug 1, 2026)
PHASE2
Mirena for the Treatment of Nonatypical Endometrial Hyperplasia for 6 Months Bayer NA WITHDRAWN
(Jul 22, 2026)
PHASE3
Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer UNICANCER NA RECRUITING
(Jul 1, 2026)
PHASE3
Progesterone Luteal Support in Unexplained Infertility Management Simone Broer NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival NRG Oncology NA COMPLETED
(Jun 1, 2026)
PHASE2, PHASE3
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix The George Washington University Biostatistics Center NA COMPLETED
(Jun 1, 2026)
PHASE3
A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix The George Washington University Biostatistics Center NA TERMINATED
(Jun 1, 2026)
PHASE3
Effect of GnRH Agonist in FET Assiut University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert Daré Bioscience, Inc. NA NOT YET RECRUITING
(May 1, 2026)
PHASE1
Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer Queen Mary University of London NA RECRUITING
(May 1, 2026)
PHASE2
Tirzepatide in the Treatment of Endometrial Cancer Rutgers, The State University of New Jersey NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors Eli Avisar, MD NA WITHDRAWN
(Apr 1, 2026)
PHASE1, PHASE2
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors NiKang Therapeutics, Inc. NA RECRUITING
(Apr 1, 2026)
PHASE1
Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone University Hospital, Ghent NA COMPLETED
(Mar 1, 2026)
PHASE3
Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer City of Hope Medical Center NA SUSPENDED
(Mar 1, 2026)


Progesterone Generic API Manufacturers

Several generic applications have been filed for Progesterone. The first generic version for Progesterone was by Fresenius Kabi Usa Llc and was approved on Apr 25, 2001. And the latest generic version is by Glenmark Pharmaceuticals Inc Usa and was approved on Apr 8, 2026.

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