ORTHO TRI-CYCLEN LO Drug Patent Profile

Which patents cover Ortho Tri-cyclen Lo, and when can generic versions of Ortho Tri-cyclen Lo launch?

Ortho Tri-cyclen Lo is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO TRI-CYCLEN LO 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 LO

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	20
Patent Applications:	8
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ORTHO TRI-CYCLEN LO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORTHO TRI-CYCLEN LO
DailyMed Link:	ORTHO TRI-CYCLEN LO at DailyMed

See drug prices for ORTHO TRI-CYCLEN LO

See drug sales revenues for ORTHO TRI-CYCLEN LO

Recent Clinical Trials for ORTHO TRI-CYCLEN LO

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 LO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ORTHO TRI-CYCLEN LO

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 ORTHO TRI-CYCLEN LO

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 LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002		DISCN	Yes	No

Expired US Patents for ORTHO TRI-CYCLEN LO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002

International Patents for ORTHO TRI-CYCLEN LO

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2225207	ТРЕХФАЗНЫЙ ПЕРОРАЛЬНЫЙ КОНТРАЦЕПТИВ (THREE-PHASE ORAL CONTRACEPTIVE)
Brazil	0012327
World Intellectual Property Organization (WIPO)	0104116
Argentina	034541	PIRROLIDINAS Y PIPERIDINAS NEUROTROFAS Y COMPOSICIONES FARMACEUTICAS Y EL USO DE LAS MISMAS PARA PREPARAR UN MEDICAMENTO
Poland	352432
Czech Republic	20012184

Supplementary Protection Certificates for ORTHO TRI-CYCLEN LO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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	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
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612