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Serving 500+ biopharmaceutical companies globally:

McKinsey
Colorcon
Cipla
Dow
US Army
Chinese Patent Office
Federal Trade Commission
Julphar
Express Scripts
AstraZeneca

Generated: August 17, 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-three patent family members on CEPHALON drugs in thirty-five countries.

Summary for Applicant: Cephalon

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
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-003Sep 30, 1997RXYesNo► Subscribe► Subscribe ► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)022249-004Sep 13, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Cephalon
FENTORA
fentanyl citrate
TABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
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
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Expired Patents for Cephalon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-002Dec 24, 1998► Subscribe► Subscribe
Cephalon
ACTIQ
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL020747-002Nov 4, 1998► Subscribe► Subscribe
Cephalon
NUVIGIL
armodafinil
TABLET;ORAL021875-001Jun 15, 2007► Subscribe► Subscribe
Cephalon
FENTANYL
fentanyl citrate
TROCHE/LOZENGE;ORAL020195-007Oct 30, 1995► 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
8,298,577Effervescent oral opiate dosage forms and methods of administering opiates► Subscribe
6,764,696 Effervescent drug delivery system for oral administration► Subscribe
6,350,470 Effervescent drug delivery system for oral administration► Subscribe
8,802,130Sublingual buccal effervescent► Subscribe
6,509,036 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
Mexico339878► Subscribe
World Intellectual Property Organization (WIPO)2009120386► Subscribe
Spain2383478► Subscribe
European Patent Office1091732► Subscribe
Czech Republic295578► 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
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
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
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
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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:

Accenture
Moodys
Teva
Daiichi Sankyo
Fuji
Novartis
Boehringer Ingelheim
US Department of Justice
Deloitte
Medtronic

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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