LO/OVRAL Drug Patent Profile

Which patents cover Lo/ovral, and when can generic versions of Lo/ovral launch?

Lo/ovral is a drug marketed by Cadence Health and Wyeth Pharms and is included in two NDAs.

The generic ingredient in LO/OVRAL is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

Summary for LO/OVRAL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	78
Formulation / Manufacturing:	see details
DailyMed Link:	LO/OVRAL at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for LO/OVRAL

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 LO/OVRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Wyeth Pharms	LO/OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	017802-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for LO/OVRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982

International Patents for LO/OVRAL

See the table below for patents covering LO/OVRAL around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	1793598	13-Alkyl-gona-1,3,5(10),8-tetraene
France	1503559	Procédé de préparation de nouveaux gonahexaènes
Austria	264728
Philippines	11432	SYNTHESIS OF 13-POLYCARBONALKYLGONA-2,5(10)-DIENE-17-OLS
Switzerland	417584	Verfahren zur Herstellung von Steroid-Verbindungen
Philippines	9896	2-POLYCARBONALKYL-1,3-CYCLOPENTANEDIONE
Switzerland	421096	Verfahren zur Herstellung von Steroiden

Supplementary Protection Certificates for LO/OVRAL

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
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 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	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
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612