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Last Updated: July 4, 2020

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YASMIN Drug Profile


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

Yasmin is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one hundred patent family members in thirty-nine countries.

The generic ingredient in YASMIN is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

US ANDA Litigation and Generic Entry Outlook for Yasmin

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for YASMIN
Drug Prices for YASMIN

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Recent Clinical Trials for YASMIN

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SponsorPhase
University of North Carolina, Chapel HillPhase 2
Foundation of Hope, North CarolinaPhase 2
University of California, San FranciscoPhase 4

See all YASMIN clinical trials

Paragraph IV (Patent) Challenges for YASMIN
Tradename Dosage Ingredient NDA Submissiondate
YASMIN TABLET;ORAL-28 drospirenone; ethinyl estradiol 021098 2005-01-07

US Patents and Regulatory Information for YASMIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 YASMIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001   Start Trial   Start Trial
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Premature patent expiration for: YASMIN

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
  Start Trial YASMIN   Start Trial

Supplementary Protection Certificates for YASMIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
0918791 PA2006009 Lithuania   Start Trial PRODUCT NAME: DROSPIRENONUM; NAT. REGISTRATION NO/DATE: LT/1/06/0520/001, 2006 07 10 LT/1/06/0520/002, 2006 07 10 LT/1/06/0520/003, 2006 07 10 LT/1/06/0520/004 20060710; FIRST REGISTRATION: RVG 31781 20050804
1380301 SPC019/2009 Ireland   Start Trial SPC019/2009: 20091119, EXPIRES: 20220628
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson
Dow
McKesson

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