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Profile for Tradename: VIVELLE-DOT

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Vivelle-dot is a drug marketed by Novartis and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug.

This drug has one hundred and fifty patent family members in twenty-eight countries.

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

Summary for Tradename: VIVELLE-DOT

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list14

Pharmacology for Tradename: VIVELLE-DOT

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Clinical Trials for: VIVELLE-DOT

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

Initiating Transdermal Estradiol Therapy in Turner's Syndrome
Status: Terminated Condition: Turner's Syndrome

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

Optimizing Ovulation Induction in the Poor Responder
Status: Withdrawn Condition: IVF Poor Responders

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

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
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-009May 3, 2002RXNo5,656,286<disabled>Y<disabled>
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-007Jan 8, 1999RXNo5,656,286<disabled><disabled>
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-005Jan 8, 1999RXNo5,656,286<disabled><disabled>
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-006Jan 8, 1999RXNo5,656,286<disabled><disabled>
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-008Jan 8, 1999RXYes5,656,286<disabled><disabled>
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Non-Orange Book Patents for Tradename: VIVELLE-DOT

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
5,300,291 Method and device for the release of drugs to the skin<disabled in preview>
5,446,070 Compositions and methods for topical administration of pharmaceutically active agents<disabled in preview>
5,405,486 Apparatus for forming a transdermal drug device<disabled in preview>
4,814,168 Transdermal multipolymer drug delivery system<disabled in preview>
5,474,783 Solubility parameter based drug delivery system and method for altering drug saturation concentration<disabled in preview>
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International Patent Family for Tradename: VIVELLE-DOT

Country Document Number Publication Date
New Zealand243200Nov 25, 1993
Australia5093790Aug 13, 1990
Japan2659837Sep 30, 1997
European Patent Office0379045Jul 25, 1990
Brazil9506470Jan 13, 2009
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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