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Last Updated: October 21, 2020

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SEASONIQUE Drug Profile

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When do Seasonique patents expire, 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-three 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. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

US ANDA Litigation and Generic Entry Outlook for Seasonique

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for SEASONIQUE
Drug Prices for SEASONIQUE

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Drug Sales Revenue Trends for SEASONIQUE

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Recent Clinical Trials for SEASONIQUE

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SponsorPhase
Duramed ResearchPhase 3
Duramed ResearchPhase 2

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Paragraph IV (Patent) Challenges for SEASONIQUE
Tradename Dosage Ingredient NDA Submissiondate
SEASONIQUE TABLET;ORAL ethinyl estradiol; levonorgestrel 021840 2008-01-22

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

Supplementary Protection Certificates for SEASONIQUE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 C20160011 00192 Estonia   Start Trial PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
1453521 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 300814 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
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Merck
McKinsey
McKesson

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