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
Brazil	0012327
Norway	20013144
South Africa	200106006	Triphasic oral contraceptive.
Czech Republic	302568	Trífázový orální antikoncepcní prostredek (Triphasic oral contraceptive composition)
Austria	318605
China	1382140

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
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124