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Last Updated: October 2, 2023

LOSEASONIQUE Drug Patent Profile


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When do Loseasonique patents expire, and when can generic versions of Loseasonique launch?

Loseasonique is a drug marketed by Teva Branded Pharm and is included in one NDA. There are three 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 LOSEASONIQUE 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 Loseasonique

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 LOSEASONIQUE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LOSEASONIQUE Tablets ethinyl estradiol; levonorgestrel 0.1 mg/0.02 mg and 0.01 mg 022262 1 2009-11-16

US Patents and Regulatory Information for LOSEASONIQUE

LOSEASONIQUE is protected by three US patents.

Patents protecting LOSEASONIQUE

Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PREVENTION OF PREGNANCY

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

Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 LOSEASONIQUE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LOSEASONIQUE

See the table below for patents covering LOSEASONIQUE around the world.

Country Patent Number Title Estimated Expiration
New Zealand 574964 Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration ⤷  Try a Trial
New Zealand 555299 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ⤷  Try a Trial
Slovenia 1453521 ⤷  Try a Trial
Spain 2428118 ⤷  Try a Trial
European Patent Office 1453521 CONTRACEPTIFS ORAUX POUR EVITER LES GROSSESSES ET DIMINUER LA SYMPTOMATOLOGIE PREMENSTRUELLE (ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY) ⤷  Try a Trial
Hungary 230759 Teherbeesés megakadályozására és menstruációs tünetek enyhítésére vagy kiküszöbölésére alkalmas orális készítmények (Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LOSEASONIQUE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 39/2015 Austria ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 2015C/042 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE, NOM/ADRESSE
1453521 C 2015 029 Romania ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521 C20160011 00192 Estonia ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
0398460 C300221 Netherlands ⤷  Try a Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521 300814 Netherlands ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
McKesson
Baxter
Mallinckrodt
AstraZeneca

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