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FEMTRACE Drug Profile
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Which patents cover Femtrace, and what generic alternatives are available?
Femtrace is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug.
This drug has eleven patent family members in ten countries.
The generic ingredient in FEMTRACE is estradiol acetate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol acetate profile page.
US ANDA Litigation and Generic Entry Outlook for Femtrace
Indicators of Generic Entry
Summary for FEMTRACE
| International Patents: | 11 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 3 |
| Patent Applications: | 272 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | FEMTRACE at DailyMed |
US Patents and Regulatory Information for FEMTRACE
| 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 | Start Trial | ||||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-002 | Aug 20, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-003 | Aug 20, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Apil | FEMTRACE | estradiol acetate | TABLET;ORAL | 021633-001 | Aug 20, 2004 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for FEMTRACE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1461043 | Start Trial |
| China | 1564689 | Start Trial |
| Australia | 2002359758 | Start Trial |
| Israel | 160797 | Start Trial |
| China | 1273141 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FEMTRACE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1214076 | 49/2008 | Austria | Start Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 1453521 | 15C0050 | France | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
| 0770388 | 9/2009 | Austria | Start Trial | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
| 0398460 | 04C0022 | France | Start Trial | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| 0398460 | 12/2004 | Austria | Start Trial | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
