OPILL Drug Patent Profile

When do Opill patents expire, and when can generic versions of Opill launch?

Opill is a drug marketed by Laboratoire Hra and is included in one NDA.

The generic ingredient in OPILL is norgestrel. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the norgestrel profile page.

Summary for OPILL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Patent Applications:	4,147
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in OPILL?	OPILL excipients list
DailyMed Link:	OPILL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OPILL

Constraining patent/regulatory exclusivity:

RX TO OTC SWITCH OR OTC USE

NDA:

017031

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for OPILL

OPILL is protected by zero US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on RX TO OTC SWITCH OR OTC USE.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting OPILL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982		OTC	Yes	Yes

Expired US Patents for OPILL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982

International Patents for OPILL

See the table below for patents covering OPILL around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	264728
Germany	1468643	Verfahren zur Herstellung von 2-(1'-Tetralyliden-aethyl)-2-alkyl-cyclopentan-1,3-dionen
France	1276081	Nouveaux intermédiaires cétoniques en vue de la synthèse des stéroïdes et leur procédé de préparation
Spain	280806
Switzerland	417584	Verfahren zur Herstellung von Steroid-Verbindungen

Supplementary Protection Certificates for OPILL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 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
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211