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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Cipla
Queensland Health
McKinsey
Covington
Accenture
UBS
US Department of Justice
Healthtrust

Generated: July 16, 2018

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.

The generic ingredient in SEASONIQUE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Drug patent expirations by year for SEASONIQUE
Generic Entry Opportunity Date for SEASONIQUE
Generic Entry Date for SEASONIQUE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for SEASONIQUE

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;ORAL 021840-001 May 25, 2006 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for SEASONIQUE
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 0.15 mg/0.03 mg/0.01 mg ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for 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
7,772,219 Methods of hormonal treatment utilizing extended cycle contraceptive regimens ➤ Try a Free Trial
8,338,396 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ➤ Try a Free Trial
8,680,084 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for SEASONIQUE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000093 Germany ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0160011 00192 Estonia ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
2016 00016 Denmark ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0814 Netherlands ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Chinese Patent Office
Queensland Health
Daiichi Sankyo
Cipla
UBS
Deloitte
Teva
Chubb

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.