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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 017031

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NDA 017031 describes OPILL, which is a drug marketed by Laboratoire Hra and is included in one NDA. It is available from one supplier. Additional details are available on the OPILL profile page.

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 017031

Tradename:	OPILL
Applicant:	Laboratoire Hra
Ingredient:	norgestrel
Patents:	0
Formulation / Manufacturing:	see details

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 017031

Generic Entry Date for 017031^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: RX TO OTC SWITCH OR OTC USE 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.

Medical Subject Heading (MeSH) Categories for 017031

Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 017031

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101	0113-8101-01	1 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK
OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101	0113-8101-03	3 BLISTER PACK in 1 CARTON (0113-8101-03) / 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	0.075MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 13, 2026
Regulatory Exclusivity Use:	RX TO OTC SWITCH OR OTC USE

Expired US Patents for NDA 017031

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

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