Details for New Drug Application (NDA): 021529

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NDA 021529 describes NEXPLANON, which is a drug marketed by Organon and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NEXPLANON profile page.

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

Summary for 021529

Tradename:	NEXPLANON
Applicant:	Organon
Ingredient:	etonogestrel
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021529

Generic Entry Date for 021529^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe Dosage: IMPLANT;IMPLANTATION

^*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.

Pharmacology for NDA: 021529

Suppliers and Packaging for NDA: 021529

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529	NDA	Organon LLC	78206-145	78206-145-01	1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK
NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529	NDA	Organon LLC	78206-145	78206-145-01	1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	IMPLANT;IMPLANTATION			Strength	68MG/IMPLANT
Approval Date:	Jul 17, 2006	TE:		RLD:	No
Patent:	⤷ Subscribe	Patent Expiration:	Jul 28, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	IMPLANT;IMPLANTATION			Strength	68MG/IMPLANT
Approval Date:	May 13, 2011	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	May 31, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Sep 28, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021529

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006	⤷ Subscribe	⤷ Subscribe
Organon	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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