CLIMARA Drug Patent Profile

✉ Email this page to a colleague

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.

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for CLIMARA?
What are the global sales for CLIMARA?
What is Average Wholesale Price for CLIMARA?

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
University of Washington	Phase 2
Breast Cancer Research Foundation	Phase 2
Johns Hopkins University	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	AB2	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
>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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	020375-006	May 27, 2003	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-003	Mar 23, 1998	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-002	Dec 22, 1994	⤷ 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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Hong Kong	1006545		⤷ Sign Up
Australia	630347		⤷ Sign Up
World Intellectual Property Organization (WIPO)	8907951		⤷ Sign Up
Japan	H03502925		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CLIMARA

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2782584	132021000000197	Italy	⤷ Sign Up	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
1380301	2009C/007	Belgium	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1214076	49/2008	Austria	⤷ Sign Up	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description