FEMPATCH Drug Patent Profile

Which patents cover Fempatch, and what generic alternatives are available?

Fempatch is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in FEMPATCH is estradiol. There are seventy-five drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fempatch

A generic version of FEMPATCH was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for FEMPATCH

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Patent Applications:	7,167
Formulation / Manufacturing:	see details
DailyMed Link:	FEMPATCH at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for FEMPATCH

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for FEMPATCH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parke Davis	FEMPATCH	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020417-001	Dec 3, 1996		DISCN	No	No

Expired US Patents for FEMPATCH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Parke Davis	FEMPATCH	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020417-001	Dec 3, 1996
Parke Davis	FEMPATCH	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020417-001	Dec 3, 1996

International Patents for FEMPATCH

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

Country	Patent Number	Title	Estimated Expiration
Australia	5784590
Japan	H0816054
European Patent Office	0483105	Dispositifs pour la délivrance transdermique de médicaments utilisant des esters d'acides gras ou des éthers d'alcohols gras des alcanediols pour améliorer l'absorption. (Solid drug-delivery devices employing fatty acid esters or fatty alcohol ethers of alkanediols as percutaneous absorption enhancers.)
Germany	3785015
Austria	87202
Portugal	90240	PROCESSO PARA A PREPARACAO DE COMPOSICOES LAMINARES PARA A ADMINISTRACAO TRANSDERMICA DE FENTANIL
Portugal	86426	DISPOSITIVO RESILIENTE PARA A ADMINISTRACAO DE UM MEDICAMENTO POR VIA TRANSDERMICA, E DISPOSITIVOS EMPREGANDO ESTERES/ETERES DE ACIDOS GORDOS DE ALCANODIOIS COMO ESTIMULADORES DA ABSORCAO PERCUTANEA

Supplementary Protection Certificates for FEMPATCH

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004	Lithuania		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	SPC/GB04/032	United Kingdom		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		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306