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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Fuji
McKesson
Farmers Insurance
Moodys
QuintilesIMS
Johnson and Johnson
UBS

Generated: May 21, 2018

DrugPatentWatch Database Preview

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-five 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 203752
Ingredient-typeEstradiol Congeners
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 Noven Therapeutics, LLC 68968-6610 N 68968-6610-8
MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752 NDA Noven Therapeutics, LLC 68968-6625 N 68968-6625-8

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.0375MG/24HR
Approval Date:Oct 29, 2012TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jul 4, 2030Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free 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 203752-001 Oct 29, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-002 Oct 29, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-002 Oct 29, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-003 Oct 29, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Farmers Insurance
Chinese Patent Office
McKinsey
Covington
Healthtrust
Johnson and Johnson
Baxter

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