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LYBREL Drug Profile

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Lybrel is a drug marketed by Wyeth Pharms Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in eight countries.

The generic ingredient in LYBREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for Tradename: LYBREL

Patents:1
Applicants:1
NDAs:1
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
Wyeth Pharms Inc
LYBREL
ethinyl estradiol; levonorgestrel
TABLET;ORAL021864-001May 22, 2007DISCNNo6,500,814► subscribe ► subscribe
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Paragraph IV activity for: LYBREL

Drugname Dosage Strength RLD Submissiondate
levonorgestrel and ethinyl estradiolTablets0.09 mg/0.02 mgLybrel10/5/2007

International Patent Family for Tradename: LYBREL

Country Document Number Estimated Expiration
European Patent Office1310257► subscribe
Spain2200384► subscribe
Germany59808545► 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: LYBREL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0001France► subscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
00221Netherlands► subscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2009 00017Denmark► subscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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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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