SEASONALE Drug Patent Profile

Which patents cover Seasonale, and when can generic versions of Seasonale launch?

Seasonale is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in SEASONALE 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 SEASONALE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	4
DailyMed Link:	SEASONALE at DailyMed

See drug sales revenues for SEASONALE

Recent Clinical Trials for SEASONALE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Duramed Research	Phase 2
The Physicians' Services Incorporated Foundation	Phase 3
The Hospital for Sick Children	Phase 3

See all SEASONALE clinical trials

Paragraph IV (Patent) Challenges for SEASONALE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SEASONALE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg	021544	1	2004-03-29

US Patents and Regulatory Information for SEASONALE

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	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003	AB	RX	Yes	Yes

Expired US Patents for SEASONALE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003
Teva Branded Pharm	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003

International Patents for SEASONALE

See the table below for patents covering SEASONALE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H1129481	ULTRA LOW DOSAGE CONTRACEPTIVE DECREASING BLEEDING AT MENSES AND HAVING SUSTAINED ACTIVITY
Japan	2007197459	ULTRA LOW DOSE CONTRACEPTIVE WITH LESS MENSTRUAL BLEEDING AND SUSTAINED EFFICACY
Portugal	911029
Austria	216241
Spain	2175650
Denmark	0911029
European Patent Office	0911029	Contraceptif oral à tres faibles doses, ayant une activité prolongée et provoquant moins d'hemorragies menstruelles (Ultra low dose oral contraceptives with less menstrual bleeding and sustained efficacy)

Supplementary Protection Certificates for SEASONALE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	39/2015	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
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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