CLIMARA Drug Patent Profile

Which patents cover Climara, and when can generic versions of Climara launch?

Climara is a drug marketed by Bayer Hlthcare and is included in two NDAs.

The generic ingredient in CLIMARA is estradiol; levonorgestrel. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; levonorgestrel profile page.

Summary for CLIMARA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	27
Patent Applications:	4,321
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CLIMARA
Drug Sales Revenues:	Drug sales revenues for CLIMARA
What excipients (inactive ingredients) are in CLIMARA?	CLIMARA excipients list
DailyMed Link:	CLIMARA at DailyMed

See drug prices for CLIMARA

See drug sales revenues for CLIMARA

Recent Clinical Trials for CLIMARA

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

Sponsor	Phase
Johns Hopkins University	Phase 4
Cystic Fibrosis Foundation	Phase 4
Sharon Nachman	Phase 2

See all CLIMARA clinical trials

Pharmacology for CLIMARA

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for CLIMARA

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

Paragraph IV (Patent) Challenges for CLIMARA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLIMARA	Transdermal System	estradiol	0.05 mg/day and 0.1 mg/day	020375		2005-09-12

US Patents and Regulatory Information for CLIMARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-004	Mar 5, 1999	AB2	RX	Yes	No
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003		RX	Yes	Yes
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-006	May 27, 2003	AB	RX	Yes	No
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-005	May 27, 2003	AB2	RX	Yes	No
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-001	Dec 22, 1994	AB2	RX	Yes	No
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-002	Dec 22, 1994	AB2	RX	Yes	Yes

Expired US Patents for CLIMARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-001	Dec 22, 1994
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-006	May 27, 2003
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-003	Mar 23, 1998
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-004	Mar 5, 1999
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-002	Dec 22, 1994
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-005	May 27, 2003

International Patents for CLIMARA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1006545
Australia	651234
Japan	2931002
Austria	109357
Australia	3280989
European Patent Office	0402407	SYSTEME D'ADMINISTRATION TRANSCUTANEE D'ESTRADIOL. (TRANSDERMAL ESTRADIOL DELIVERY SYSTEM.)

Supplementary Protection Certificates for CLIMARA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1453521	15C0050	France		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		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521	C201630040	Spain		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		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211