TRIPHASIL-28 Drug Patent Profile

Which patents cover Triphasil-28, and when can generic versions of Triphasil-28 launch?

Triphasil-28 is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in TRIPHASIL-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for TRIPHASIL-28

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	339
Formulation / Manufacturing:	see details
DailyMed Link:	TRIPHASIL-28 at DailyMed

Recent Clinical Trials for TRIPHASIL-28

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

Sponsor	Phase
Desmond Tutu HIV Centre	N/A
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3

See all TRIPHASIL-28 clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TRIPHASIL-28

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

US Patents and Regulatory Information for TRIPHASIL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984		DISCN	Yes	No

Expired US Patents for TRIPHASIL-28

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984

International Patents for TRIPHASIL-28

See the table below for patents covering TRIPHASIL-28 around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	471112	Verfahren zur Herstellung von 4- Vinylchroman-4-olen
Switzerland	565730	Steroid intermediates for total synthesis
Netherlands	6402300
Netherlands	146502
Hong Kong	47080	CONTRACEPTIVE METHOD AND PACK
United Kingdom	1141772

Supplementary Protection Certificates for TRIPHASIL-28

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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	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
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008