Details for New Drug Application (NDA): 203752

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NDA 203752 describes MINIVELLE, which is a drug marketed by Noven and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the MINIVELLE profile page.

The generic ingredient in MINIVELLE is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.

Summary for 203752

Tradename:	MINIVELLE
Applicant:	Noven
Ingredient:	estradiol
Patents:	4

Pharmacology for NDA: 203752

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 203752

Estrogens

Suppliers and Packaging for NDA: 203752

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752	NDA AUTHORIZED GENERIC	Noven Therapeutics, LLC	68968-3410	68968-3410-8	8 POUCH in 1 CARTON (68968-3410-8) / 1 d in 1 POUCH
MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752	NDA AUTHORIZED GENERIC	Noven Therapeutics, LLC	68968-3425	68968-3425-8	8 POUCH in 1 CARTON (68968-3425-8) / 1 d in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.0375MG/24HR
Approval Date:	Oct 29, 2012	TE:	AB3	RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Jul 4, 2030	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Jul 10, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
Patent:	⤷ Subscribe	Patent Expiration:	Jul 10, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 203752

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	⤷ Subscribe	⤷ Subscribe
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012	⤷ Subscribe	⤷ Subscribe
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	⤷ Subscribe	⤷ Subscribe
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012	⤷ Subscribe	⤷ Subscribe
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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