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Serving 500+ biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
Express Scripts
Baxter
Argus Health
Daiichi Sankyo
Novartis
US Department of Justice
Citi
Julphar

Generated: July 22, 2017

DrugPatentWatch Database Preview

Noven Company Profile

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What is the competitive landscape for NOVEN, and what generic alternatives to NOVEN drugs are available?

NOVEN has six approved drugs.

There are seven US patents protecting NOVEN drugs and there have been two Paragraph IV challenges on NOVEN drugs in the past three years. There are three tentative approvals on NOVEN drugs.

There are seventy-one patent family members on NOVEN drugs in thirty-one countries.

Summary for Applicant: Noven

Patents:7
Tradenames:9
Ingredients:6
NDAs:6
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-002Oct 29, 2012RXYesNo8,231,906► SubscribeYY ► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 2006RXYesNo9,034,370► SubscribeY ► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 2006RXYesNo8,632,802► SubscribeY ► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 2006RXYesNo6,210,705► SubscribeY ► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 2006RXYesNo9,034,370► SubscribeY ► Subscribe
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Expired Patents for Noven

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, 19985,958,446► Subscribe
Noven
DENTIPATCH
lidocaine
PATCH;TOPICAL020575-002May 21, 19965,234,957► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 19985,656,286► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-004Apr 6, 20065,958,446► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 20125,656,286► Subscribe
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Paragraph IV activity for NOVEN drugs

Drugname Dosage Strength Tradename Submissiondate
estradiol
Transdermal System0.025 mg/day
MINIVELLE
5/8/2015
estradiol
Transdermal System0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/day
MINIVELLE
8/18/2014
methylphenidate
Transdermal System10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs and 30 mg/9 hrs
DAYTRANA
4/13/2011

Non-Orange Book Patents for Noven

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
8,916,191Device for transdermal administration of drugs including acrylic polymers► Subscribe
9,333,263Device for transdermal administration of drugs including acrylic based polymers► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Noven Drugs

Country Document Number Estimated Expiration
Austria253355► Subscribe
China101120934► Subscribe
Japan5285198► Subscribe
Turkey200001736► Subscribe
Portugal1037615► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Noven Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving 500+ biopharmaceutical companies globally:

Moodys
Covington
Harvard Business School
Mallinckrodt
Baxter
Cantor Fitzgerald
Fuji
Dow
QuintilesIMS
US Army

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.

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