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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. Sixteen 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: see list3

Pharmacology for Tradename: VIVELLE-DOT

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Clinical Trials for: VIVELLE-DOT

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
5,656,285 Method for forming a transdermal drug device<disabled in preview>
4,994,278 Breathable backing<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>
5,300,291 Method and device for the release of drugs to the skin<disabled in preview>
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International Patent Family for Tradename: VIVELLE-DOT

Country Document Number Publication Date
South Korea100391229Nov 01, 2003
JapanH06508820Oct 06, 1994
Denmark0591432Jan 06, 2003
Portugal92829Feb 29, 1996
South Africa9604735Dec 19, 1996
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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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