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Serving leading biopharmaceutical companies globally:

AstraZeneca
UBS
Queensland Health
US Department of Justice
Citi
Cantor Fitzgerald
Healthtrust
McKinsey
Colorcon
QuintilesIMS

Generated: October 24, 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 nine US patents protecting NOVEN drugs on NOVEN drugs in the past three years. There are three tentative approvals on NOVEN drugs.

There are seventy-two patent family members on NOVEN drugs in thirty-one countries and thirty-six supplementary protection certificates in eleven countries.

Summary for Applicant: Noven

International Patents:72
US Patents:9
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;TRANSDERMAL203752-003Oct 29, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Noven
FENTANYL-25
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL077775-001Oct 16, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-004Apr 6, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998RXYesYes► Subscribe► Subscribe► Subscribe
Noven
FENTANYL-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL077775-004Oct 16, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-005Sep 23, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Noven

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-004Oct 29, 2012► Subscribe► Subscribe
Noven
DENTIPATCH
lidocaine
PATCH;TOPICAL020575-002May 21, 1996► Subscribe► Subscribe
Noven
DENTIPATCH
lidocaine
FILM, EXTENDED RELEASE;BUCCAL020575-001May 21, 1996► Subscribe► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-001Oct 29, 2012► Subscribe► Subscribe
Noven
DENTIPATCH
lidocaine
PATCH;TOPICAL020575-002May 21, 1996► Subscribe► Subscribe
Noven
DENTIPATCH
lidocaine
FILM, EXTENDED RELEASE;BUCCAL020575-001May 21, 1996► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 2006► Subscribe► 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
China101120934► Subscribe
Peru01202000► Subscribe
China1368876► Subscribe
World Intellectual Property Organization (WIPO)0069422► Subscribe
Brazil0010467► Subscribe
World Intellectual Property Organization (WIPO)2010006143► Subscribe
Spain2219926► Subscribe
Russian Federation2233156► Subscribe
European Patent Office3173078► Subscribe
Japan2017039781► 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
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
C/GB09/026United Kingdom► SubscribePRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
2014 00016Denmark► SubscribePRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0136011/03Switzerland► SubscribePRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
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
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
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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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Chinese Patent Office
Novartis
Dow
Medtronic
Deloitte
Teva
Colorcon
McKesson
Covington

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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