Estradiol - Generic Drug Details
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What are the generic 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-two patent family members in twenty-six countries.
There are seventy-five drug master file entries for estradiol. Forty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for estradiol
International Patents: | 182 |
US Patents: | 55 |
Tradenames: | 43 |
Applicants: | 57 |
NDAs: | 84 |
Drug Master File Entries: | 75 |
Finished Product Suppliers / Packagers: | 44 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-006 | May 27, 2003 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | ||||
Barr Labs Inc | ESTRADIOL | estradiol | TABLET;ORAL | 040197-003 | Oct 22, 1997 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
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 | |||
Amneal | ESTRADIOL | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 211396-003 | Sep 28, 2020 | AB3 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Dr Reddys | ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 083547-001 | Approved Prior to Jan 1, 1982 | 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 |
Expired US Patents for estradiol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-006 | Jan 8, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-002 | Oct 28, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ALORA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020655-003 | Dec 20, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-007 | Jan 8, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-002 | Dec 22, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-001 | Oct 28, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-005 | Jan 8, 1999 | ⤷ 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 | 2013277236 | Natural combination hormone replacement formulations and therapies | ⤷ Try a Trial |
Australia | 2021218231 | Vaginal Inserted Estradiol Pharmaceutical Compositions and Methods | ⤷ Try a Trial |
Russian Federation | 2015100533 | ЕСТЕСТВЕННАЯ КОМБИНАЦИЯ СОСТАВОВ И СПОСОБОВ ГОРМОНОЗАМЕСТИТЕЛЬНОЙ ТЕРАПИИ | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2018227172 | ⤷ Try a Trial | |
Australia | 2016366200 | Vaginal inserted estradiol pharmaceutical compositions and methods | ⤷ Try a Trial |
South Korea | 20210107915 | 천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) | ⤷ Try a Trial |
Japan | 6285866 | ⤷ 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 |
---|---|---|---|---|
0770388 | PA2009004,C0770388 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103 |
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 |
0402407 | 97C0005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711 |
1214076 | SZ 49/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
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 |
2782584 | 21C1058 | France | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406 |
0285237 | 95C0008 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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