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Last Updated: December 8, 2019

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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 five 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-one 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:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 203752
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 203752
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 (68968-3410-1)
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 (68968-3425-1)
Paragraph IV (Patent) Challenges for 203752
Tradename Dosage Ingredient NDA Submissiondate
MINIVELLE FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 203752 2015-05-08
MINIVELLE FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 203752 2014-08-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.0375MG/24HR
Approval Date:Oct 29, 2012TE:AB3RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jul 4, 2030Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jul 10, 2028Product 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

Expired US Patents for NDA 203752

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

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