.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203752

« Back to Dashboard
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 two 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-eight suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the estradiol profile page.

Summary for NDA: 203752

Tradename:
MINIVELLE
Applicant:
Noven
Ingredient:
estradiol
Patents:2
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

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 68968-6610-8 8 POUCH in 1 PACKET (68968-6610-8) > 1 d in 1 POUCH (68968-6610-1)
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL 203752 NDA Noven Therapeutics, LLC 68968-6625 68968-6625-8 8 POUCH in 1 PACKET (68968-6625-8) > 1 d in 1 POUCH (68968-6625-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.0375MG/24HR
Approval Date:Oct 29, 2012TE:RLD:No
Patent:6,841,716Patent Expiration:Apr 27, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:8,231,906Patent Expiration:Jul 4, 2030Product Flag?YSubstance Flag?YDelist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.075MG/24HR
Approval Date:Oct 29, 2012TE:RLD:No
Patent:6,841,716Patent Expiration:Apr 27, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 203752

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-001Oct 29, 20125,656,286► subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 20125,656,286► subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-002Oct 29, 20126,024,976► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc