QUARTETTE Drug Patent Profile

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-three 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

Summary for QUARTETTE

International Patents:	23
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	417
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for QUARTETTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QUARTETTE
What excipients (inactive ingredients) are in QUARTETTE?	QUARTETTE excipients list
DailyMed Link:	QUARTETTE at DailyMed

See drug prices for QUARTETTE

See drug sales revenues for QUARTETTE

Anatomical Therapeutic Chemical (ATC) Classes for QUARTETTE

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03AD	Emergency contraceptives
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

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
Teva Branded Pharm	QUARTETTE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	204061-001	Mar 28, 2013	AB	RX	Yes	Yes			Y

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

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Russian Federation

South Korea

Taiwan

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
Japan	2008515909
Canada	2582530	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)
Taiwan	200626161	Methods of hormonal treatment utilizing ascending-dose extended cycle regimens
Israel	198441	שיטות למניעת הריון בנקבות בשימוש במינונים הורמוניים עולים (Methods of female contraception using ascending hormonal dosages)
China	101626760	Methods of hormonal treatment utilizing ascending-dose extended cycle regimens

Supplementary Protection Certificates for QUARTETTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521	15C0050	France		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	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211