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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-eight 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:	3
Clinical Trials:	5
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEASONIQUE
DailyMed Link:	SEASONIQUE at DailyMed

Generic Entry Opportunity Date for SEASONIQUE

NDA:

021840

Dosage::

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

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Paragraph IV (Patent) Challenges for SEASONIQUE

Drugname	Dosage	Strength	RLD	Date
	Tablets	0.15 mg/0.03 mg/0.01 mg

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

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International Patents for SEASONIQUE

Country	Document Number	Estimated Expiration
Poland	213122
Spain	2428118
Mexico	PA04005445
New Zealand	570295

Supplementary Protection Certificates for SEASONIQUE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211