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SEASONIQUE Drug Profile

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Which patents cover Seasonique, 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 four 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 SEASONIQUE 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 SEASONIQUE

International Patents:	61
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Clinical Trials:	5
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	SEASONIQUE at DailyMed

US Patents and Regulatory Information for SEASONIQUE

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
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	AB	RX	Yes	Yes			Y
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	AB	RX	Yes	Yes
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	AB	RX	Yes	Yes

Paragraph IV (Patent) Challenges for SEASONIQUE

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	0.15 mg/0.03 mg/0.01 mg		2008-01-22

Non-Orange Book US Patents for SEASONIQUE

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

International Patents for SEASONIQUE

Country	Document Number	Estimated Expiration
Luxembourg	93156
Canada	2524474
Russian Federation	2006101214
Hungary	0402651

Supplementary Protection Certificates for SEASONIQUE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0160011 00192	Estonia		PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
00221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629