Estradiol - Generic Drug Details
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What are the generic drug sources for estradiol and what is the scope of freedom to operate?
Estradiol
is the generic ingredient in forty-three branded drugs marketed by Allergan, Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Abbvie, Bayer Hlthcare, Amneal, Mylan Technologies, Zydus Pharms, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms, Chemo Research Sl, Novitium Pharma, Pfizer, Mayne Pharma, Padagis Us, Women First Hlthcare, Novartis, Ortho Mcneil Pharm, Sandoz, Bristol Myers Squibb, Barr Labs Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Lannett Co Inc, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Glenmark Pharms Ltd, Millicent, Apil, Dr Reddys, Pharmacia And Upjohn, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Am Regent, Fosun Pharma, Hikma, Xiromed, Savage Labs, Noven Pharms Inc, Lupin Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Myovant Sciences, and Teva Womens, and is included in eighty-four NDAs. There are fifty-five patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Estradiol has one hundred and eighty-three patent family members in twenty-six countries.
There are seventy-five drug master file entries for estradiol. Forty-five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for estradiol
International Patents: | 183 |
US Patents: | 55 |
Tradenames: | 43 |
Applicants: | 57 |
NDAs: | 84 |
Drug Master File Entries: | 75 |
Finished Product Suppliers / Packagers: | 45 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 987 |
Patent Applications: | 6,728 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
Generic filers with tentative approvals for ESTRADIOL
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 3MG;2MG;3MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 1MG;2MG;2MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for estradiol
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Zydus Pharms | ESTRADIOL | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 202985-001 | Mar 29, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Epic Pharma Llc | ESTRADIOL | estradiol | TABLET;ORAL | 040275-001 | Dec 29, 1998 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Exeltis Usa Inc | ESTRASORB | estradiol hemihydrate | EMULSION;TOPICAL | 021371-001 | Oct 9, 2003 | DISCN | Yes | 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 |
Expired US Patents for estradiol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-004 | Oct 28, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ALORA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020655-004 | Apr 5, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Noven | MINIVELLE | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 203752-002 | Oct 29, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ALORA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020655-004 | Apr 5, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-004 | Mar 5, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Women First Hlthcare | ESCLIM | estradiol | SYSTEM;TRANSDERMAL | 020847-003 | Aug 4, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for estradiol
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2021218231 | Vaginal Inserted Estradiol Pharmaceutical Compositions and Methods | ⤷ Try a Trial |
Croatia | P20211377 | ⤷ Try a Trial | |
European Patent Office | 2861233 | TRAITEMENT TRANSDERMIQUE DE SUBSTITUTION HORMONALE (TRANSDERMAL HORMONE REPLACEMENT THERAPIES) | ⤷ Try a Trial |
Japan | 2018024685 | 天然複合ホルモン補充製剤および療法 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) | ⤷ Try a Trial |
Japan | 2019206540 | プロゲステロン製剤 (PROGESTERONE FORMULATIONS) | ⤷ Try a Trial |
Poland | 2861072 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for estradiol
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | C 2015 029 | Romania | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
1453521 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
2782584 | C202130068 | Spain | ⤷ Try a Trial | PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406 |
0770388 | SPC/GB09/026 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208 |
0770388 | 2009/012 | Ireland | ⤷ Try a Trial | PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103 |
1380301 | CA 2009 00017 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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