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LOSEASONIQUE Drug Profile

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When do Loseasonique patents expire, and what generic alternatives are available?

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-one 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-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for LOSEASONIQUE

International Patents:	61
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	3
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	LOSEASONIQUE at DailyMed

US Patents and Regulatory Information for LOSEASONIQUE

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

Paragraph IV (Patent) Challenges for LOSEASONIQUE

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	0.1 mg/0.02 mg and 0.01 mg		2009-11-16

Non-Orange Book US Patents for LOSEASONIQUE

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
8,680,084	Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
7,772,219	Methods of hormonal treatment utilizing extended cycle contraceptive regimens
7,320,969	Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
8,338,396	Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology

International Patents for LOSEASONIQUE

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004098517
Russian Federation	2351339
Israel	162182
Russian Federation	2403046

Supplementary Protection Certificates for LOSEASONIQUE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
00C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0160011 00192	Estonia		PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015