Menostar Patent Expiration

Menostar is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 21, 2017. Details of Menostar'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).
US5891868 Methods for treating postmenopausal women using ultra-low doses of estrogen
Nov, 2017

(8 years ago)

Expired
US6692763 Methods for treating postmenopausal women using ultra-low doses of estrogen
Nov, 2017

(8 years ago)

Expired

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US patents provide insights into the exclusivity only within the United States, but Menostar 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 Menostar's family patents as well as insights into ongoing legal events on those patents.

Menostar's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Menostar:

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




Generic Launch

Generic Release Date:

Menostar's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 21, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Menostar Generic API suppliers:

Estradiol is the generic name for the brand Menostar. 26 different companies have already filed for the generic of Menostar, with Mylan Technologies having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Menostar's generic

Alternative Brands for Menostar

Menostar which is used for preventing postmenopausal osteoporosis., has several other brand drugs in the same treatment category and using the same active ingredient (Estradiol). 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 Treatment Area
Wyeth Pharms
Duavee used for management of menopausal symptoms and prevention of osteoporosis.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Estradiol. Given below is the list of those drugs and companies owning them.



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





About Menostar

Menostar is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for preventing postmenopausal osteoporosis. Menostar uses Estradiol as an active ingredient. Menostar was launched by Bayer in 2004.

Approval Date:

Menostar was approved by FDA for market use on 08 June, 2004.

Active Ingredient:

Menostar uses Estradiol as the active ingredient. Check out other Drugs and Companies using Estradiol ingredient

Treatment:

Menostar is used for preventing postmenopausal osteoporosis.

Dosage:

Menostar is available in system form for transdermal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.014MG/24HR SYSTEM Prescription TRANSDERMAL