ESTRADIOL Drug Patent Profile
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Which patents cover Estradiol, and when can generic versions of Estradiol launch?
Estradiol is a drug marketed by Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Amneal, Mylan Technologies, Zydus Pharms, Solaris Pharma Corp, Chemo Research Sl, Novitium Pharma, Quagen, Ortho Mcneil Pharm, Barr Labs Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Lannett Co Inc, Norvium Bioscience, Usl Pharma, Amneal Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Xiromed, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs. and is included in forty-seven NDAs.
The generic ingredient in ESTRADIOL is estradiol valerate. There are seventy-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Estradiol
A generic version of ESTRADIOL was approved as estradiol valerate by AM REGENT on January 19th, 2010.
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Summary for ESTRADIOL
| US Patents: | 0 |
| Applicants: | 32 |
| NDAs: | 47 |
| Finished Product Suppliers / Packagers: | 36 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 1,002 |
| Patent Applications: | 4,119 |
| Drug Prices: | Drug price information for ESTRADIOL |
| Drug Sales Revenues: | Drug sales revenues for ESTRADIOL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ESTRADIOL |
| What excipients (inactive ingredients) are in ESTRADIOL? | ESTRADIOL excipients list |
| DailyMed Link: | ESTRADIOL at DailyMed |
Recent Clinical Trials for ESTRADIOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Anna Stanhewicz, PhD | Early Phase 1 |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 4 |
| Alexion Pharmaceuticals, Inc. | Phase 1 |
Pharmacology for ESTRADIOL
| Drug Class | Estrogen |
| Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for ESTRADIOL
Anatomical Therapeutic Chemical (ATC) Classes for ESTRADIOL
Paragraph IV (Patent) Challenges for ESTRADIOL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| IMVEXXY | Vaginal Inserts | estradiol | 4 mcg and 10 mcg | 208564 | 1 | 2019-12-30 |
| MINIVELLE | Transdermal System | estradiol | 0.025 mg/day | 203752 | 1 | 2015-05-08 |
| MINIVELLE | Transdermal System | estradiol | 0.0375 mg/day 0.05 mg/day 0.075 mg/day 0.1 mg/day | 203752 | 1 | 2014-08-18 |
| VAGIFEM | Vaginal Tablets | estradiol | 10 mcg | 020908 | 1 | 2013-01-02 |
| VIVELLE-DOT | Transdermal System | estradiol | 0.025 mg/day 0.0375 mg/day 0.05 mg/days 0.075 mg/day 0.1 mg/day | 020538 | 1 | 2010-04-27 |
| CLIMARA | Transdermal System | estradiol | 0.05 mg/day and 0.1 mg/day | 020375 | 2005-09-12 |
US Patents and Regulatory Information for ESTRADIOL
ESTRADIOL is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting ESTRADIOL
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barr Labs Inc | ESTRADIOL | estradiol | TABLET;ORAL | 040197-002 | Oct 22, 1997 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novast Labs | ESTRADIOL AND NORETHINDRONE ACETATE | estradiol; norethindrone acetate | TABLET;ORAL | 210612-002 | Apr 3, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novitium Pharma | ESTRADIOL | estradiol | GEL;TRANSDERMAL | 217610-005 | Aug 24, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
