Estradiol Patent Expiration

Estradiol was first introduced by Novartis Pharmaceuticals Corp in its drug Estraderm on Sep 10, 1986. Other drugs containing Estradiol are Vagifem, Imvexxy, Estrogel, Fempatch, Menostar, Climara, Estring, Esclim, Vivelle, Elestrin, Minivelle, Evamist, Alora, Estradiol, Vivelle-Dot, Divigel. 38 different companies have introduced drugs containing Estradiol.


Estradiol Patents

Given below is the list of patents protecting Estradiol, 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
Imvexxy US11266661 Vaginal inserted estradiol pharmaceutical compositions and methods Feb 02, 2034 Mayne Pharma
Imvexxy US10258630 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US10398708 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US10471072 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US10537581 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US10568891 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US10668082 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US10806697 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US10835487 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US10888516 Soluble estradiol capsule for vaginal insertion Nov 21, 2032 Mayne Pharma
Imvexxy US11065197 Soluble estradiol capsule for vaginal insertion Nov 21, 2032 Mayne Pharma
Imvexxy US11116717 Soluble estradiol capsule for vaginal insertion Nov 21, 2032 Mayne Pharma
Imvexxy US11123283 Soluble estradiol capsule for vaginal insertion Nov 21, 2032 Mayne Pharma
Imvexxy US11241445 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US11246875 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US11304959 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US11351182 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US11497709 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Imvexxy US9180091 Soluble estradiol capsule for vaginal insertion Nov 21, 2032 Mayne Pharma
Imvexxy US9289382 Vaginal inserted estradiol pharmaceutical compositions and methods Nov 21, 2032 Mayne Pharma
Minivelle US8231906 Transdermal estrogen device and delivery Jul 04, 2030 Noven
Minivelle US9724310 Transdermal estrogen device and delivery Jul 10, 2028 Noven
Minivelle US9730900 Transdermal estrogen device and delivery Jul 10, 2028 Noven
Minivelle US9833419 Transdermal estrogen device and delivery Jul 10, 2028 Noven
Vagifem US7018992 Hormone composition Sep 17, 2022

(Expired)

Novo Nordisk Inc
Elestrin US7198801 Formulations for transdermal or transmucosal application Jun 25, 2022

(Expired)

Viatris
Evamist US6978945 Dispensing device Nov 30, 2021

(Expired)

Padagis Us
Elestrin US7470433 Formulations for transdermal or transmucosal application Aug 03, 2021

(Expired)

Viatris
Minivelle US6841716 Patch Apr 27, 2020

(Expired)

Noven
Menostar US5891868 Methods for treating postmenopausal women using ultra-low doses of estrogen Nov 21, 2017

(Expired)

Bayer Hlthcare
Menostar US6692763 Methods for treating postmenopausal women using ultra-low doses of estrogen Nov 21, 2017

(Expired)

Bayer Hlthcare
Vagifem US5860946 Instrument for inserting a suppository Jul 01, 2017

(Expired)

Novo Nordisk Inc
Evamist US6299900 Dermal penetration enhancers and drug delivery systems involving same Feb 19, 2017

(Expired)

Padagis Us
Evamist US6818226 Dermal penetration enhancers and drug delivery systems involving same Feb 19, 2017

(Expired)

Padagis Us
Evamist US6923983 Transdermal delivery of hormones Feb 19, 2017

(Expired)

Padagis Us
Minivelle US5646286 Palladium catalyzed vinylic substitution reactions with 2-substituted-pyridines Aug 12, 2014

(Expired)

Noven
Minivelle US5656286 Solubility parameter based drug delivery system and method for altering drug saturation concentration Aug 12, 2014

(Expired)

Noven
Vivelle-dot US5656286 Solubility parameter based drug delivery system and method for altering drug saturation concentration Aug 12, 2014

(Expired)

Sandoz
Minivelle US6024976 Solubility parameter based drug delivery system and method for altering drug saturation concentration Jan 07, 2014

(Expired)

Noven
Vivelle-dot US6024976 Solubility parameter based drug delivery system and method for altering drug saturation concentration Jan 07, 2014

(Expired)

Sandoz
Vivelle-dot US5474783 Solubility parameter based drug delivery system and method for altering drug saturation concentration Dec 12, 2012

(Expired)

Sandoz
Vivelle-dot US5958446 Solubility parameter based drug delivery system and method for altering drug saturation concentration Dec 12, 2012

(Expired)

Sandoz



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Estradiol's patents.

Given below is the list recent legal activities going on the following patents of Estradiol.

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 28 Mar, 2006 US7018992
Recordation of Patent Grant Mailed 28 Mar, 2006 US7018992
Issue Notification Mailed 08 Mar, 2006 US7018992
Receipt into Pubs 23 Feb, 2006 US7018992
Dispatch to FDC 22 Feb, 2006 US7018992
Application Is Considered Ready for Issue 22 Feb, 2006 US7018992
Receipt into Pubs 20 Jan, 2006 US7018992
Printer Rush- No mailing 27 Sep, 2005 US7018992
Pubs Case Remand to TC 06 Sep, 2005 US7018992
Workflow - File Sent to Contractor 03 Jun, 2005 US7018992


About Veterinary Estradiol

Estradiol is used in a drug marketed by 1 company: Elanco Us Inc.

Other drugs containing Estradiol are: Compudose , encore .

Estradiol's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Estradiol:

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
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NA RECRUITING
(Sep 16, 2026)
PHASE3
Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Sep 4, 2026)
PHASE2
GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients Xiaojun Chen NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE1
hCG Priming in Women With Diminished Ovarian Reserve Kristine Loessl NA RECRUITING
(Sep 1, 2026)
PHASE3
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) Deciphera Pharmaceuticals, LLC NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects Corium Innovations, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study of Eloralintide (LY3841136) in Female Participants With Obesity or Overweight Eli Lilly and Company NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Stereotactic Radiosurgery in Treating Patients With Greater Than 3 Melanoma Brain Metastases M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Estrogen Administration for the Treatment of NASH in Postmenopausal Women Massachusetts General Hospital NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles Mylan Technologies Inc. NA COMPLETED
(Aug 1, 2026)
PHASE3
Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections Stephanie Wang Zuo NA COMPLETED
(Aug 1, 2026)
PHASE2
A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives AbbVie NA COMPLETED
(Aug 1, 2026)
PHASE1
Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI Benha University NA COMPLETED
(Aug 1, 2026)
PHASE2
Medical Imaging to Re-evaluate Elacestrant Clinical Usage Jules Bordet Institute NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Analysis of the Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women Nutrindo Ideais Research Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia LIB Therapeutics LLC NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Pre-pubertal Low Dose Transdermal Estradiol in Turner Syndrome Children's National Research Institute NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Investigate the Repeat-dose Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With Ganfeborole in Female Participants of Non-childbearing Potential GlaxoSmithKline NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patients With Endometriosis The Third Xiangya Hospital of Central South University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
4FMFES-PET Imaging of ER+ Advanced Breast Cancers Centre de recherche du Centre hospitalier universitaire de Sherbrooke NA RECRUITING
(Jul 1, 2026)
PHASE2
Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer National Cancer Institute (NCI) NA RECRUITING
(Jul 1, 2026)
PHASE2
Intra-ovarian Injection of MSC-EVs in Idiopathic Premature Ovarian Failure Royan Institute NA COMPLETED
(Jul 1, 2026)
PHASE1, PHASE2
Convergent Mechanisms Underlying Reprometabolic Syndrome in Women University of Colorado, Denver NA RECRUITING
(Jul 1, 2026)
PHASE2
Role of Estrogen on Skeletal Outcomes in FHA University of Virginia NA RECRUITING
(Jul 1, 2026)
PHASE2
A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants AbbVie NA COMPLETED
(Jul 1, 2026)
PHASE1
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA) Eurofarma Laboratorios S.A. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Jun 17, 2026)
PHASE2
[18F]FES PET/CT in Endocrine Refractory Breast Cancer University of Pennsylvania NA TERMINATED
(Jun 1, 2026)
PHASE2
[18F]FES PET/.CT in Uterine Cancer Abramson Cancer Center at Penn Medicine NA RECRUITING
(Jun 1, 2026)
PHASE2
Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration. ART Fertility Clinics LLC NA SUSPENDED
(Jun 1, 2026)
PHASE1
18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer Università Vita-Salute San Raffaele NA RECRUITING
(Jun 1, 2026)
PHASE2
The Role of Estrogen in the Neurobiology of Eating Disorders Massachusetts General Hospital NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Transdermal Estrogen in Women With Anorexia Nervosa Pouneh K. Fazeli, MD NA RECRUITING
(May 1, 2026)
PHASE2
Estradiol in Treating Patients With ER Beta Positive, Triple Negative Locally Advanced or Metastatic Breast Cancer Mayo Clinic NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy Sumitomo Pharma Switzerland GmbH NA COMPLETED
(May 1, 2026)
PHASE3
Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction National Cancer Institute (NCI) NA RECRUITING
(May 1, 2026)
PHASE2
Combined Oral Contraceptive Pill and Resistance Starch University of Pennsylvania NA RECRUITING
(May 1, 2026)
PHASE2
Impact of Formulation Change on Ovarian Suppression in Young Breast Cancer Patients. Fudan University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Individualized Prolonged Luteal Support After Fresh Embryo Transfer in Women With Low Progesterone University Hospital, Montpellier NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy University of Washington NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Pre-Exposure Prophylaxis (PrEP)- Gender Affirming Hormone Therapy (GAHT) Interactions in TGW Johns Hopkins University NA COMPLETED
(Apr 1, 2026)
PHASE1
A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood Boehringer Ingelheim NA COMPLETED
(Apr 1, 2026)
PHASE1
STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER) Dartmouth-Hitchcock Medical Center NA RECRUITING
(Apr 1, 2026)
PHASE2
Progesterone Primed Protocol Versus GnRH Antagonist in With PCO Undergoing ICSI Beni-Suef University NA COMPLETED
(Apr 1, 2026)
PHASE2, PHASE3
Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea Massachusetts General Hospital NA RECRUITING
(Apr 1, 2026)
PHASE3
Progesterone-modified Natural Cycle for FET Shandong University of Traditional Chinese Medicine NA RECRUITING
(Apr 1, 2026)
PHASE3
A Study of Elenestinib in Healthy Adult Female Participants Blueprint Medicines Corporation NA COMPLETED
(Apr 1, 2026)
PHASE1
Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception The University of Hong Kong NA RECRUITING
(Mar 1, 2026)
PHASE3
An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany NA COMPLETED
(Mar 1, 2026)
PHASE1
Effect of Pentoxyfilline on Endometrial Thickness and Frozen Embryo Transfer Outcomes Beni-Suef University NA RECRUITING
(Mar 1, 2026)
PHASE3


Estradiol Generic API Manufacturers

Several generic applications have been filed for Estradiol. The first generic version for Estradiol was by Bristol Myers Squibb Co Pharmaceutical Research Institute and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Encube Ethicals Private Ltd and was approved on May 11, 2026.

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