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	019081-002	Sep 10, 1986
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	019081-003	Sep 10, 1986
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986

International Patents for ESTRADERM

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

Country	Patent Number	Title	Estimated Expiration
Sweden	396695	ANORDNING FOR FRIGORANDE AV ETT AKTIVT MEDEL I EN REGLERAD MENGD PER TIDSENHET UNDER LENGRE TIDSPERIODER
Denmark	140517
Germany	2247949
Switzerland	574742
Cyprus	1400	DOSAGE FORM FOR COADMINISTERING DRUG AND PERCUTANEOUS ABSORPTION ENHANCER

Supplementary Protection Certificates for ESTRADERM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
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
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
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