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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
QuintilesIMS
Fuji
UBS
McKinsey
Cipla
Citi
US Army
Mallinckrodt
Moodys

Generated: December 13, 2017

DrugPatentWatch Database Preview

SEASONALE Drug Profile

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

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

This drug has eleven patent family members in nine countries and twelve supplementary protection certificates in eight countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Teva Branded PharmSEASONALEethinyl estradiol; levonorgestrelTABLET;ORAL021544-001Sep 5, 2003ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Teva Branded PharmSEASONALEethinyl estradiol; levonorgestrelTABLET;ORAL021544-001Sep 5, 2003ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: SEASONALE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded PharmSEASONALEethinyl estradiol; levonorgestrelTABLET;ORAL021544-001Sep 5, 2003► Subscribe► Subscribe
Teva Branded PharmSEASONALEethinyl estradiol; levonorgestrelTABLET;ORAL021544-001Sep 5, 2003► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Denmark0911029► Subscribe
Germany69804918► Subscribe
Japan2007197459► Subscribe
JapanH1129481► Subscribe
Canada2256977► Subscribe
Portugal911029► Subscribe
Canada2596416► Subscribe
European Patent Office0911029► Subscribe
Norway982815► Subscribe
Austria216241► 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
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
49/2008Austria► SubscribePRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: 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
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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Serving leading biopharmaceutical companies globally:

Covington
Dow
Deloitte
Queensland Health
Boehringer Ingelheim
Novartis
Express Scripts
McKesson
Moodys
Fish and Richardson

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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