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Profile for Tradename: COMBIPATCH

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Combipatch is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from two 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 COMBIPATCH is estradiol; norethindrone acetate. There are seventy-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

Summary for Tradename: COMBIPATCH

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list8

Pharmacology for Tradename: COMBIPATCH

Clinical Trials for: COMBIPATCH

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
Status: Completed Condition: Healthy

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions
Status: Completed Condition: Healthy

Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
Status: Not yet recruiting Condition: Endometrial Hyperplasia; Endometrial Cancer

Endometrial Safety Study
Status: Completed Condition: Postmenopause

Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)
Status: Completed Condition: Sexual Dysfunction

An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
Status: Completed Condition: Folliculogenesis

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 Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998RXNo5,656,286<disabled> <disabled>
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998RXYes5,656,286<disabled> <disabled>
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Expired Patents for Tradename: COMBIPATCH

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 19985,474,783<disabled>
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 19985,474,783<disabled>
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 19986,024,976<disabled>
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Non-Orange Book Patents for Tradename: COMBIPATCH

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
5,958,446 Solubility parameter based drug delivery system and method for altering drug saturation concentration<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>
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International Patent Family for Tradename: COMBIPATCH

Country Document Number Publication Date
Netherlands9020171Jan 02, 1991
Norway923699Sep 24, 1992
Australia658870May 04, 1995
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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.

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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
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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