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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Argus Health
Mallinckrodt
UBS
Fuji
Dow
Merck
US Department of Justice
Chubb
Medtronic

Generated: September 19, 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.

Summary for Applicant: Noven

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 Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-002Oct 29, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-004Apr 6, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Noven
FENTANYL-100
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL077775-004Oct 16, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-005Sep 23, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Noven
FENTANYL-75
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL077775-003Oct 16, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-004Oct 29, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-004Oct 29, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Noven
FENTANYL-50
fentanyl
FILM, EXTENDED RELEASE;TRANSDERMAL077775-002Oct 16, 2009DISCNNoNo► Subscribe► Subscribe► 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;TRANSDERMAL020870-001Aug 7, 1998► 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
DENTIPATCH
lidocaine
PATCH;TOPICAL020575-002May 21, 1996► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 2006► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998► Subscribe► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-001Oct 29, 2012► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998► Subscribe► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-004Oct 29, 2012► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 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
Germany60006380► Subscribe
Peru01202000► Subscribe
European Patent Office2310001► Subscribe
Czech Republic305817► Subscribe
Japan2013056944► Subscribe
Japan2011527697► Subscribe
Taiwan200406231► Subscribe
Japan2002510600► Subscribe
Latvia12558► Subscribe
TaiwanI511733► 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
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
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
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2009004Lithuania► SubscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2006000022Germany► SubscribePRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
09/012Ireland► SubscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Daiichi Sankyo
Healthtrust
Harvard Business School
Dow
QuintilesIMS
Chubb
Accenture
Baxter
Moodys

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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