Crinone Patent Expiration

Crinone is a drug owned by Abbvie Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 15, 2013. Details of Crinone's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5543150 Method of progesterone delivery and affect thereof
Sep, 2013

(13 years ago)

Expired

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US patents provide insights into the exclusivity only within the United States, but Crinone is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Crinone's family patents as well as insights into ongoing legal events on those patents.

Crinone's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Crinone:

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)




Generic Launch

Generic Release Date:

Crinone's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 15, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Crinone Generic API suppliers:

Progesterone is the generic name for the brand Crinone. 12 different companies have already filed for the generic of Crinone, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Crinone's generic

Alternative Brands for Crinone

Crinone which is used for hormonal support in women, such as in hormone replacement therapy or fertility treatments., has several other brand drugs using the same active ingredient (Progesterone). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Covis
Makena (autoinjector)
Ferring
Endometrin
Ferring Pharms Inc
Milprosa
Mayne Pharma
Bijuva
Pfizer
Depo-subq Provera 104
Wyeth Pharms
Premphase 14/14
Prempro


Apart from brand drugs containing the same ingredient, some generics have also been filed for Progesterone, Crinone's active ingredient. Check the complete list of approved generic manufacturers for Crinone





About Crinone

Crinone is a drug owned by Abbvie Inc. It is used for hormonal support in women, such as in hormone replacement therapy or fertility treatments. Crinone uses Progesterone as an active ingredient. Crinone was launched by Abbvie in 1997.

Approval Date:

Crinone was approved by FDA for market use on 31 July, 1997.

Active Ingredient:

Crinone uses Progesterone as the active ingredient. Check out other Drugs and Companies using Progesterone ingredient

Treatment:

Crinone is used for hormonal support in women, such as in hormone replacement therapy or fertility treatments.

Dosage:

Crinone is available in gel form for vaginal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
8% GEL Prescription VAGINAL
4% GEL Discontinued VAGINAL