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Profile for Tradename: MINIVELLE

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Minivelle is a drug marketed by Noven and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-two patent family members in twenty-nine countries.

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

Summary for Tradename: MINIVELLE

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list5

Pharmacology for Tradename: MINIVELLE

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Clinical Trials for: MINIVELLE

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Status: Active, not recruiting Condition: Atrophic Vaginitis; Breast Cancer

Postpartum Depression: Transdermal Estradiol Versus Sertraline
Status: Terminated Condition: Postpartum Depression

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
Status: Completed Condition: Hot Flashes

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
Status: Completed Condition: Sexual Dysfunction, Physiological

Duragen Versus Duraguard in Chiari Surgery
Status: Completed Condition: Chiari Malformation

Perimenopausal Effects of Estradiol on Reward Responsiveness
Status: Not yet recruiting Condition: Perimenopausal Depression

A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC
Status: Completed Condition: Contraception; Bleeding

Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ethinyl Estradiol and Norethindrone; Healthy Volunteers

Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Status: Terminated Condition: Vulvar Atrophy; Vaginal Atrophy

MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms
Status: Completed Condition: Hot Flashes; Menopause; Vasomotor Disturbance

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-005Sep 23, 2014RXNo8,231,906<disabled>YY<disabled>
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 2012RXNo6,841,716<disabled>Y<disabled>
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-001Oct 29, 2012RXNo8,231,906<disabled>YY<disabled>
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-004Oct 29, 2012RXYes8,231,906<disabled>YY<disabled>
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 2012RXNo5,656,286<disabled>YY<disabled>
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Paragraph IV activity for: MINIVELLE

Drugname Dosage Strength RLD Submissiondate
estradiolTransdermal System0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/dayMinivelle8/18/2014

Non-Orange Book Patents for Tradename: MINIVELLE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,221,383 Solubility parameter based drug delivery system and method for altering drug saturation concentration<disabled in preview>
5,300,291 Method and device for the release of drugs to the skin<disabled in preview>
5,234,957 Compositions and methods for topical administration of pharmaceutically active agents<disabled in preview>
4,814,168 Transdermal multipolymer drug delivery system<disabled in preview>
5,332,576 Compositions and methods for topical administration of pharmaceutically active agents<disabled in preview>
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International Patent Family for Tradename: MINIVELLE

Country Document Number Publication Date
Denmark0474647Aug 18, 1997
Australia3284789Sep 22, 1989
World Intellectual Property Organization (WIPO)0069422Nov 23, 2000
Spain2071683Jul 01, 1995
Norway923699Sep 24, 1992
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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