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Serving leading biopharmaceutical companies globally:

Novartis
US Army
Covington
Merck
Cerilliant
Citi
Fuji
Healthtrust
Farmers Insurance
AstraZeneca

Generated: October 19, 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-two patent family members in twenty-two countries and twelve 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-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for Tradename: SEASONIQUE

US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Clinical Trials: see list5
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SEASONIQUE at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006ABRXYesYes► Subscribe► Subscribe ► Subscribe
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006ABRXYesYes► Subscribe► Subscribe ► Subscribe
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006ABRXYesYes► 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
7,772,219Methods of hormonal treatment utilizing extended cycle contraceptive regimens► Subscribe
8,338,396Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology► 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
Japan2010180236► Subscribe
European Patent Office2305229► Subscribe
Australia2008237614► Subscribe
Canada2655959► Subscribe
Poland213122► Subscribe
Japan2005516913► Subscribe
South Africa200404249► Subscribe
Russian Federation2004121155► Subscribe
Japan2011157389► Subscribe
Russian Federation2006101214► 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
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
/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
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0160011 00192Estonia► SubscribePRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
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Serving leading biopharmaceutical companies globally:

Julphar
Queensland Health
Accenture
UBS
Medtronic
Colorcon
Boehringer Ingelheim
Federal Trade Commission
Fuji
Citi

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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