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YASMIN Drug Profile

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

This drug has one hundred and thirty-three patent family members in forty-one countries.

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

Summary for Tradename: YASMIN

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 2001RXYes6,787,531► subscribeY ► subscribe
Bayer Hlthcare
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 2001RXYes6,933,395► subscribeY ► subscribe
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Expired Patents for Tradename: YASMIN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 20015,569,652► subscribe
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Paragraph IV activity 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
6,787,531
YASMIN
September 07, 2016

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
Norway2010004► subscribe
New Zealand517845► subscribe
Estonia05128► 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
2009 00017Denmark► subscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076/01Switzerland► subscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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
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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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