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Serving leading biopharmaceutical companies globally:

Accenture
Harvard Business School
Cipla
Colorcon
Chubb
McKesson
Boehringer Ingelheim
Merck
Daiichi Sankyo
Cerilliant

Generated: December 14, 2017

DrugPatentWatch Database Preview

SEASONIQUE Drug Profile

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Which patents cover Seasonique, and when can generic versions of Seasonique launch?

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

This drug has sixty-one patent family members in twenty-two countries and thirteen supplementary protection certificates in nine countries.

The generic ingredient in SEASONIQUE 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 PharmSEASONIQUEethinyl estradiol; levonorgestrelTABLET;ORAL021840-001May 25, 2006ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Teva Branded PharmSEASONIQUEethinyl estradiol; levonorgestrelTABLET;ORAL021840-001May 25, 2006ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Teva Branded PharmSEASONIQUEethinyl estradiol; levonorgestrelTABLET;ORAL021840-001May 25, 2006ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Teva Branded PharmSEASONIQUEethinyl estradiol; levonorgestrelTABLET;ORAL021840-001May 25, 2006ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for SEASONIQUE

Drugname Dosage Strength RLD Submissiondate
levonorgestrel; ethinyl estradiol; ethinyl estradiolTablets0.15 mg/0.03 mg/0.01 mgSeasonique1/22/2008

Non-Orange Book Patents for Tradename: SEASONIQUE

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
8,338,396Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology► Subscribe
7,772,219Methods of hormonal treatment utilizing extended cycle contraceptive regimens► Subscribe
8,680,084Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology► 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: SEASONIQUE

Country Document Number Estimated Expiration
China101757628► Subscribe
European Patent Office2305229► Subscribe
New Zealand533242► Subscribe
Australia2004257772► Subscribe
China1599614► Subscribe
MexicoPA04005445► Subscribe
New Zealand555299► Subscribe
South Africa200600201► Subscribe
World Intellectual Property Organization (WIPO)03049744► Subscribe
Australia2008237614► 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: SEASONIQUE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
49/2008Austria► SubscribePRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
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
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
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
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Serving leading biopharmaceutical companies globally:

Healthtrust
US Army
Boehringer Ingelheim
Teva
Deloitte
Federal Trade Commission
Chinese Patent Office
Covington
AstraZeneca
Medtronic

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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