ESTRADERM Drug Patent Profile

When do Estraderm patents expire, and what generic alternatives are available?

Estraderm is a drug marketed by Novartis and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Estraderm

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

Summary for ESTRADERM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
Patent Applications:	6,502
Formulation / Manufacturing:	see details
DailyMed Link:	ESTRADERM at DailyMed

Recent Clinical Trials for ESTRADERM

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

Sponsor	Phase
National Institute on Aging (NIA)	Phase 1/Phase 2
Massachusetts General Hospital	Phase 1/Phase 2
Massachusetts General Hospital	Phase 2/Phase 3

See all ESTRADERM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ESTRADERM

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 ESTRADERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986		DISCN	Yes	No
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986		DISCN	Yes	No

Expired US Patents for ESTRADERM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-002	Sep 10, 1986

International Patents for ESTRADERM

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

Country	Patent Number	Title	Estimated Expiration
Israel	40450	DEVICE FOR RELEASING A DRUG AT A CONTROLLED RATE FOR A PROLONGED PERIOD OF TIME
United Kingdom	2093694	DOSAGE FORM FOR COADMINISTERING DRUG AND PERCUTANEOUS ABSORPTION ENHANCER
Austria	336189
Netherlands	161983
Sweden	396695	ANORDNING FOR FRIGORANDE AV ETT AKTIVT MEDEL I EN REGLERAD MENGD PER TIDSENHET UNDER LENGRE TIDSPERIODER
Spain	407155

Supplementary Protection Certificates for ESTRADERM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
2782584	C202130068	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414