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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Medtronic
Julphar
Harvard Business School
Mallinckrodt
Teva
Chinese Patent Office
Moodys
Baxter

Generated: October 21, 2017

DrugPatentWatch Database Preview

Cephalon Company Profile

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What is the competitive landscape for CEPHALON, and when can generic versions of CEPHALON drugs launch?

CEPHALON has eight approved drugs.

There are twenty-seven US patents protecting CEPHALON drugs on CEPHALON drugs in the past three years.

There are one hundred and eighty-five patent family members on CEPHALON drugs in thirty-five countries and twelve supplementary protection certificates in five countries.

Summary for Applicant: Cephalon

International Patents:185
US Patents:27
Tradenames:8
Ingredients:6
NDAs:8
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)022249-004Sep 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)022249-003Sep 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-005Apr 16, 1999ABRXYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-004Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-002Dec 24, 1998ABRXYesYes► Subscribe► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes► Subscribe► SubscribeY► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-004Nov 4, 1998ABRXYesNo► Subscribe► Subscribe► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Cephalon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-005Mar 26, 2009► Subscribe► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-003Jun 15, 2007► Subscribe► Subscribe
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-002Dec 24, 1998► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-001Nov 4, 1998► Subscribe► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-002Sep 30, 1997► Subscribe► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-001Sep 30, 1997► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-005Mar 26, 2009► Subscribe► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-001Sep 30, 1997► Subscribe► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-002Sep 30, 1997► Subscribe► Subscribe
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Paragraph IV activity for CEPHALON drugs

Drugname Dosage Strength Tradename Submissiondate
arsenic trioxide
Injection1 mg/mL
TRISENOX
8/11/2015
bendamustine hydrochloride
Injection90 mg/mL, 0.5 mL and 2 mL in single-dose vials
TREANDA
6/19/2014
tiagabine hydrochloride
Tablets12 mg and 16 mg
GABITRIL
1/24/2014
bendamustine hydrochloride
Injection25 mg/vial and 100 mg/vial
TREANDA
6/4/2013
armodafinil
Tablets100 mg and 200 mg
NUVIGIL
9/11/2009
fentanyl citrate
Buccal Tablets0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg
FENTORA
11/13/2007
tiagabine hydrochloride
Tablets2 mg and 4 mg
GABITRIL
2/1/2005
fentanyl citrate
Lozenges0.6 mg
ACTIQ
12/20/2004
fentanyl citrate
Lozenges0.8 mg, 1.2 mg and 1.6 mg
ACTIQ
11/22/2004
fentanyl citrate
Lozenges0.2 mg
ACTIQ
10/29/2004
fentanyl citrate
Lozenges0.4 mg
ACTIQ
10/6/2004

Non-Orange Book Patents for Cephalon

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
8,461,350Bendamustine pharmaceutical compositions► Subscribe
6,641,838 Effervescent drug delivery system for oral administration► Subscribe
6,350,470 Effervescent drug delivery system for oral administration► Subscribe
6,770,304 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol► Subscribe
7,879,364Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol► Subscribe
8,298,577Effervescent oral opiate dosage forms and methods of administering opiates► Subscribe
7,858,121Effervescent oral fentanyl dosage form and methods of administering fentanyl► Subscribe
6,509,036 Effervescent drug delivery system for oral administration► Subscribe
6,576,250 Pharmaceutical compositions for rectal and vaginal administration► Subscribe
6,764,696 Effervescent drug delivery system for oral administration► 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 Cephalon Drugs

Country Document Number Estimated Expiration
TaiwanI380830► Subscribe
Japan5685611► Subscribe
Canada2548915► Subscribe
Australia747474► Subscribe
Brazil9814857► Subscribe
Spain2360114► Subscribe
Japan5688195► Subscribe
Spain2324908► Subscribe
Denmark1964557► Subscribe
Japan2007517053► 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 Cephalon Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0107Belgium► SubscribePRODUCT NAME: TIAGABINE CHLORHYDRATE MONOHYDRATE - TIAGABINE ANHYDRE; NAT. REGISTRATION NO/DATE: 403 IS 102 F 3 19970602; FIRST REGISTRATION: FR 341 260.2 19960614
C/GB98/022United Kingdom► SubscribePRODUCT NAME: TIAGABINE ( INCLUDING SALTS THEREOF ); REGISTERED: FR AMM NO. 341 260.2 19960614; FR AMM NO. 341 262.5 19960614; FR AMM NO. 341 264.8 19960614; UK 03132/0117 19971111; UK 03132/0118 19971111; UK 03132/0119 19971111
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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
2006000022Germany► SubscribePRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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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:

US Department of Justice
Mallinckrodt
Queensland Health
McKinsey
Harvard Business School
QuintilesIMS
Farmers Insurance
Novartis
Cantor Fitzgerald
Citi

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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