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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Chinese Patent Office
Accenture
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Covington
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Citi
Merck
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Generated: December 18, 2017

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YASMIN Drug Profile

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When do Yasmin patents expire, and when can generic versions of Yasmin launch?

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

This drug has one hundred and fifty-three patent family members in forty-two countries and seven supplementary protection certificates in seven countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer HlthcareYASMINdrospirenone; ethinyl estradiolTABLET;ORAL-28021098-001May 11, 2001ABRXYesYes► Subscribe► SubscribeY► Subscribe
Bayer HlthcareYASMINdrospirenone; ethinyl estradiolTABLET;ORAL-28021098-001May 11, 2001ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: YASMIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer HlthcareYASMINdrospirenone; ethinyl estradiolTABLET;ORAL-28021098-001May 11, 2001► Subscribe► Subscribe
Bayer HlthcareYASMINdrospirenone; ethinyl estradiolTABLET;ORAL-28021098-001May 11, 2001► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for YASMIN

Drugname Dosage Strength RLD Submissiondate
drospirenone and ethinyl estradiolTablets3 mg/0.03 mgYasmin1/7/2005

Premature patent expiration for: YASMIN

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
► Subscribe YASMIN ► Subscribe

Non-Orange Book Patents for Tradename: YASMIN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,121,465 Process for production drospirenone and intermediate products of the process► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: YASMIN

Country Document Number Estimated Expiration
Denmark1598069► Subscribe
Austria215557► Subscribe
Bulgaria62776► Subscribe
Spain2320626► Subscribe
Bulgaria65204► Subscribe
Russian Federation2269342► Subscribe
Brazil0014159► Subscribe
Hong Kong1047247► Subscribe
Slovakia287634► Subscribe
European Patent Office1149841► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: YASMIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2006009Lithuania► SubscribePRODUCT 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
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
49/2008Austria► SubscribePRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
C019/2009Ireland► SubscribeSPC019/2009: 20091119, EXPIRES: 20220628
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
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Serving leading biopharmaceutical companies globally:

Argus Health
Deloitte
Cantor Fitzgerald
Express Scripts
Moodys
Baxter
Federal Trade Commission
Healthtrust
Cipla
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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