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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Moodys
Colorcon
Express Scripts
Farmers Insurance
Fuji
Teva
Cantor Fitzgerald

Generated: September 19, 2018

DrugPatentWatch Database Preview

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.

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.

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up

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
8,338,396 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ➤ Sign Up
7,772,219 Methods of hormonal treatment utilizing extended cycle contraceptive regimens ➤ Sign Up
8,680,084 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for SEASONIQUE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0160011 00192 Estonia ➤ Sign Up PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
00221 Netherlands ➤ Sign Up PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
/2015 Austria ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2006 00038 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0814 Netherlands ➤ Sign Up 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:

Federal Trade Commission
Queensland Health
Moodys
Colorcon
Express Scripts
Farmers Insurance
Fuji
Teva
Cantor Fitzgerald

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