CLIMARA Drug Patent Profile

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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.

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Summary for CLIMARA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	28
Patent Applications:	4,119
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

Drug patent expirations by year for CLIMARA

Recent Clinical Trials for CLIMARA

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

Sponsor	Phase
Breast Cancer Research Foundation	Phase 2
University of Washington	Phase 2
Cystic Fibrosis Foundation	Phase 4

See all CLIMARA clinical trials

Pharmacology for CLIMARA

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

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

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Glossary

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

Expired US Patents for CLIMARA

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

International Patents for CLIMARA

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

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Country	Patent Number	Title	Estimated Expiration
Luxembourg	88849		⤷ Sign Up
World Intellectual Property Organization (WIPO)	8907951		⤷ Sign Up
European Patent Office	0402407	SYSTEME D'ADMINISTRATION TRANSCUTANEE D'ESTRADIOL. (TRANSDERMAL ESTRADIOL DELIVERY SYSTEM.)	⤷ Sign Up
Hong Kong	1006545		⤷ Sign Up
Japan	H03502925		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CLIMARA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004,C0770388	Lithuania	⤷ Sign Up	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
0770388	9/2009	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
1453521	C 2015 029	Romania	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
2782584	LUC00245	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701
1453521	CA 2016 00016	Denmark	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description