FEMHRT Drug Patent Profile

When do Femhrt patents expire, and when can generic versions of Femhrt launch?

Femhrt is a drug marketed by Apil and is included in one NDA.

The generic ingredient in FEMHRT is ethinyl estradiol; norethindrone acetate. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for FEMHRT

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	1
Drug Prices:	Drug price information for FEMHRT
What excipients (inactive ingredients) are in FEMHRT?	FEMHRT excipients list
DailyMed Link:	FEMHRT at DailyMed

See drug prices for FEMHRT

See drug sales revenues for FEMHRT

Recent Clinical Trials for FEMHRT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Florida	N/A
Johns Hopkins University	N/A
Cedars-Sinai Medical Center	N/A

See all FEMHRT clinical trials

US Patents and Regulatory Information for FEMHRT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-001	Jan 14, 2005		DISCN	Yes	No
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-002	Oct 15, 1999		DISCN	Yes	No

Expired US Patents for FEMHRT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-001	Jan 14, 2005
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-002	Oct 15, 1999

International Patents for FEMHRT

See the table below for patents covering FEMHRT around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	94392
Australia	599082
Australia	6913087
Canada	1300017	PREPARATION POUR PREVENIR L'OSTEOPOROSE (COMPOSITION FOR PREVENTING OSTEOPOROSIS)
Germany	3787386
Denmark	174892
Denmark	99987

Supplementary Protection Certificates for FEMHRT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804