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Last Updated: June 21, 2024

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QUARTETTE Drug Patent Profile


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Which patents cover Quartette, and what generic alternatives are available?

Quartette 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 twenty-three patent family members in thirteen countries.

The generic ingredient in QUARTETTE 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 Quartette

There have been two 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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Paragraph IV (Patent) Challenges for QUARTETTE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
QUARTETTE Tablets ethinyl estradiol; levonorgestrel 0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg 204061 1 2013-07-10

US Patents and Regulatory Information for QUARTETTE

QUARTETTE is protected by two US patents.

Patents protecting QUARTETTE

Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
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 QUARTETTE ethinyl estradiol; levonorgestrel TABLET;ORAL 204061-001 Mar 28, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm QUARTETTE ethinyl estradiol; levonorgestrel TABLET;ORAL 204061-001 Mar 28, 2013 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for QUARTETTE

When does loss-of-exclusivity occur for QUARTETTE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1931
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 05294269
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0516247
Estimated Expiration: ⤷  Sign Up

Patent: 0716291
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 82530
Estimated Expiration: ⤷  Sign Up

Patent: 68211
Estimated Expiration: ⤷  Sign Up

China

Patent: 1068552
Estimated Expiration: ⤷  Sign Up

Patent: 1626760
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 14556
Estimated Expiration: ⤷  Sign Up

Patent: 79461
Estimated Expiration: ⤷  Sign Up

Patent: 92332
Estimated Expiration: ⤷  Sign Up

Patent: 92333
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 8441
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 08515909
Estimated Expiration: ⤷  Sign Up

Patent: 10508275
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 07004120
Estimated Expiration: ⤷  Sign Up

Patent: 09004616
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 09120528
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 090094437
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 0626161
Estimated Expiration: ⤷  Sign Up

Patent: 0831107
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QUARTETTE around the world.

Country Patent Number Title Estimated Expiration
Taiwan 200626161 Methods of hormonal treatment utilizing ascending-dose extended cycle regimens ⤷  Sign Up
European Patent Office 1814556 PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES SCHEMAS POSOLOGIQUES A CYCLE ETENDU A AUGMENTATION DE DOSAGE (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS) ⤷  Sign Up
Japan 2008515909 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for QUARTETTE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1453521 CA 2016 00016 Denmark ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: 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.