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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.
DrugPatentWatch® Generic Entry Outlook for Femtrace
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 21, 2021. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for FEMTRACE
International Patents: | 11 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Bulk Api Vendors: | 3 |
Patent Applications: | 576 |
Formulation / Manufacturing: | see details |
DailyMed Link: | FEMTRACE at DailyMed |

DrugPatentWatch® Estimated Generic Entry Opportunity Date for FEMTRACE
Generic Entry Date for FEMTRACE*:
Constraining patent/regulatory exclusivity:
NDA:
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.
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 | |||
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 |
---|---|---|
Norway | 20042565 | Start Trial |
China | 1564689 | Start Trial |
New Zealand | 532491 | Start Trial |
Australia | 2002359758 | Start Trial |
Japan | 2005517673 | 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 |
---|---|---|---|---|
1380301 | CA 2009 00017 | Denmark | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
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 |
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 |
1453521 | C201630040 | Spain | Start Trial | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
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 |
1453521 | 93156 | Luxembourg | Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |