ORTHO TRI-CYCLEN Drug Patent Profile

When do Ortho Tri-cyclen patents expire, and what generic alternatives are available?

Ortho Tri-cyclen is a drug marketed by Janssen Pharms and is included in two NDAs.

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

Summary for ORTHO TRI-CYCLEN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	20
Patent Applications:	8
Drug Prices:	Drug price information for ORTHO TRI-CYCLEN
DailyMed Link:	ORTHO TRI-CYCLEN at DailyMed

See drug prices for ORTHO TRI-CYCLEN

Recent Clinical Trials for ORTHO TRI-CYCLEN

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

Sponsor	Phase
Gilead Sciences	Phase 1
Lexicon Pharmaceuticals	Phase 1
Aegerion Pharmaceuticals, Inc.	Phase 1

See all ORTHO TRI-CYCLEN clinical trials

US Patents and Regulatory Information for ORTHO TRI-CYCLEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992		DISCN	No	No
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992		DISCN	Yes	No
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002		DISCN	Yes	No

Expired US Patents for ORTHO TRI-CYCLEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992

International Patents for ORTHO TRI-CYCLEN

See the table below for patents covering ORTHO TRI-CYCLEN around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	450108
New Zealand	181130	17 BETA-ETHYNYL-1M BETA-ACYLOXY-13 BETA-ETHYL-9ALPHA,10ALPHA-GON-4-EN-3-ONE OXIMES
Yugoslavia	173376
Sweden	7608407
Australia	501808
Canada	1226221	ANTI-PROGRESTATIF TRIPHASE POUR ADMINISTRATION PAR VOIE ORALE (TRIPHASIC ORAL CONTRACEPTIVE)

Supplementary Protection Certificates for ORTHO TRI-CYCLEN

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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307