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Last Updated: May 28, 2024

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SEASONIQUE Drug Patent 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 two 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. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

DrugPatentWatch® Generic Entry Outlook for Seasonique

Annual sales in 2021 were $6mm indicating the motivation for generic entry (peak sales were $109mm in 2011).

There has been one patent litigation case 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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Paragraph IV (Patent) Challenges for SEASONIQUE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SEASONIQUE Tablets ethinyl estradiol; levonorgestrel 0.15 mg/0.03 mg/0.01 mg 021840 2008-01-22

US Patents and Regulatory Information for SEASONIQUE

SEASONIQUE is protected by two US patents.

Patents protecting SEASONIQUE

Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION

Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: PREVENTION OF PREGNANCY

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 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SEASONIQUE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SEASONIQUE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 15C0050 France ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 300814 Netherlands ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076 C01214076/01 Switzerland ⤷  Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.