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Estradiol acetate - Generic Drug Details
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What are the generic drug 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 are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Estradiol acetate has eleven patent family members in ten countries.
There are seventy-five drug master file entries for estradiol acetate.
Summary for estradiol acetate
| International Patents: | 11 |
| US Patents: | 3 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 75 |
| Bulk Api Vendors: | 5 |
| Clinical Trials: | 103 |
| Patent Applications: | 415 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | estradiol acetate at DailyMed |
Recent Clinical Trials for estradiol acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme Corp. | Early Phase 1 |
| University of Utah | Early Phase 1 |
| TherapeuticsMD | Phase 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Millicent | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-002 | Mar 20, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Start 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 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 | Start Trial | Start Trial |
| Millicent | FEMRING | estradiol acetate | INSERT, EXTENDED RELEASE;VAGINAL | 021367-002 | Mar 20, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for estradiol acetate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1564689 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03055495 | Start Trial |
| Israel | 160797 | Start Trial |
| Mexico | PA04006057 | Start Trial |
| Canada | 2470703 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for estradiol acetate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0398460 | SPC/GB04/032 | United Kingdom | Start Trial | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| 1380301 | 2009C/007 | Belgium | Start Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 0770388 | PA2009004 | Lithuania | Start 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 |
| 0398460 | C300221 | Netherlands | Start Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1453521 | CA 2016 00016 | Denmark | Start Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
