Estradiol acetate - Generic Drug Details
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What are the generic sources for estradiol acetate and what is the scope of patent protection?
Estradiol acetate
is the generic ingredient in two branded drugs marketed by Millicent and Apil, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Estradiol acetate has eleven patent family members in ten countries.
One supplier is listed for this compound.
Summary for estradiol acetate
International Patents: | 11 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 13 |
Clinical Trials: | 119 |
Patent Applications: | 893 |
What excipients (inactive ingredients) are in estradiol acetate? | estradiol acetate excipients list |
DailyMed Link: | estradiol acetate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for estradiol acetate
Generic Entry Date for estradiol acetate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for estradiol acetate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bio Genuine (Shanghai) Biotech Co., Ltd. | Phase 3 |
University of Chicago | Phase 4 |
Myovant Sciences GmbH | Phase 4 |
Pharmacology for estradiol acetate
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for estradiol acetate
US Patents and Regulatory Information for estradiol acetate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Millicent | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-001 | Mar 20, 2003 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | DISCN | Yes | 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 |
Expired US Patents for estradiol acetate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Millicent | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-001 | Mar 20, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for estradiol acetate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 03055495 | ⤷ Sign Up | |
New Zealand | 532491 | Oral pharmaceutical products containing 17beta-estradiol-3-lower alkanoate, method of administering the same and process of preparation | ⤷ Sign Up |
Australia | 2002359758 | ⤷ Sign Up | |
Norway | 20042565 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for estradiol acetate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | C 2015 029 | Romania | ⤷ Sign Up | 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 |
0770388 | PA2009004 | Lithuania | ⤷ Sign Up | 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 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
2782584 | 21C1058 | France | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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