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SEASONIQUE Drug Profile

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Which patents cover Seasonique, and what substitute generic drugs are available?

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 fifty-seven patent family members in twenty-one 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. There is one tentative approval for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for Tradename: SEASONIQUE

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Clinical Trials: see list4
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SEASONIQUE at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006RXYesYes7,320,969► Subscribe ► Subscribe
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006RXYesYes7,858,605► SubscribeY ► Subscribe
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006RXYesYes7,615,545► Subscribe ► Subscribe
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006RXYesYes7,855,190► Subscribe ► Subscribe
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Paragraph IV activity 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
8,680,084Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology► Subscribe
7,772,219Methods of hormonal treatment utilizing extended cycle contraceptive regimens► 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
Russian Federation2010118424► Subscribe
China1599614► Subscribe
Hungary0402651► Subscribe
Canada2524474► Subscribe
Spain2561491► 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
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
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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