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SEASONALE Drug Profile

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Seasonale is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in nine countries.

The generic ingredient in SEASONALE 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: SEASONALE

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
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
Teva Branded Pharm
SEASONALE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021544-001Sep 5, 2003RXYes5,898,032► subscribe ► subscribe
Teva Branded Pharm
SEASONALE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021544-001Sep 5, 2003RXYesRE39861► subscribe ► subscribe
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Paragraph IV activity for: SEASONALE

Drugname Dosage Strength RLD Submissiondate
levonorgestrel and ethinyl estradiolTablets0.15 mg/0.03 mgSeasonale3/29/2004

International Patent Family for Tradename: SEASONALE

Country Document Number Estimated Expiration
European Patent Office0911029► subscribe
Denmark0911029► subscribe
Canada2596416► 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: SEASONALE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00016Denmark► subscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
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
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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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