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, Chemo Research Sl, Novitium Pharma, Ortho Mcneil Pharm, Barr Labs Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Lannett Co Inc, Usl Pharma, Amneal Pharms, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Dr Reddys, Am Regent, Fosun Pharma, Hikma, Watson Labs, and Xiromed. and is included in forty-three 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.
Summary for ESTRADIOL
| US Patents: | 0 |
| Applicants: | 29 |
| NDAs: | 43 |
| Finished Product Suppliers / Packagers: | 33 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 987 |
| Patent Applications: | 6,572 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Gary Schwartz | Phase 1 |
| Dartmouth-Hitchcock Medical Center | Phase 1 |
| Beni-Suef University | Phase 2/Phase 3 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Pharms Ltd | ESTRADIOL | estradiol | TABLET;VAGINAL | 210264-001 | Sep 14, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Ortho Mcneil Pharm | ESTRADIOL | estradiol | SYSTEM;TRANSDERMAL | 021048-001 | Sep 20, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal | ESTRADIOL | estradiol | SYSTEM;TRANSDERMAL | 211293-002 | Feb 4, 2019 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Am Regent | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 090920-001 | Jan 19, 2010 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | ESTRADIOL | estradiol | SYSTEM;TRANSDERMAL | 206241-005 | Dec 1, 2022 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Lannett Co Inc | ESTRADIOL | estradiol | TABLET;ORAL | 040138-002 | Jan 30, 1998 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
