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Serving leading biopharmaceutical companies globally:

Citi
Farmers Insurance
Express Scripts
Accenture
Fish and Richardson
US Department of Justice
Dow
Mallinckrodt
QuintilesIMS
Deloitte

Generated: December 12, 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-six patent family members on CEPHALON drugs in thirty-five countries and twelve supplementary protection certificates in five countries.

Summary for Cephalon

International Patents:186
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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-003Sep 25, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-001Dec 24, 1998ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTRISENOXarsenic trioxideINJECTABLE;INJECTION021248-001Sep 25, 2000RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-006Nov 4, 1998ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-002Sep 25, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-005Sep 25, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-003Sep 25, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonFENTORAfentanyl citrateTABLET;BUCCAL, SUBLINGUAL021947-001Sep 25, 2006RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTRISENOXarsenic trioxideINJECTABLE;INJECTION021248-001Sep 25, 2000RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Cephalon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-004Nov 4, 1998► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-001Sep 30, 1997► Subscribe► Subscribe
CephalonNUVIGILarmodafinilTABLET;ORAL021875-001Jun 15, 2007► Subscribe► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-002Dec 24, 1998► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-003Sep 30, 1997► Subscribe► Subscribe
CephalonNUVIGILarmodafinilTABLET;ORAL021875-005Mar 26, 2009► Subscribe► Subscribe
CephalonPROVIGILmodafinilTABLET;ORAL020717-001Dec 24, 1998► Subscribe► Subscribe
CephalonACTIQfentanyl citrateTROCHE/LOZENGE;TRANSMUCOSAL020747-003Nov 4, 1998► Subscribe► Subscribe
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Paragraph IV activity for CEPHALON drugs

Drugname Dosage Strength Tradename Submissiondate
arsenic trioxideInjection1 mg/mLTRISENOX8/11/2015
bendamustine hydrochlorideInjection90 mg/mL, 0.5 mL and 2 mL in single-dose vialsTREANDA6/19/2014
tiagabine hydrochlorideTablets12 mg and 16 mgGABITRIL1/24/2014
bendamustine hydrochlorideInjection25 mg/vial and 100 mg/vialTREANDA6/4/2013
armodafinilTablets100 mg and 200 mgNUVIGIL9/11/2009
armodafinilTablets50 mg, 150 mg and 250 mgNUVIGIL7/24/2009
fentanyl citrateBuccal Tablets0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mgFENTORA11/13/2007
tiagabine hydrochlorideTablets2 mg and 4 mgGABITRIL2/1/2005
fentanyl citrateLozenges0.6 mgACTIQ12/20/2004
fentanyl citrateLozenges0.8 mg, 1.2 mg and 1.6 mgACTIQ11/22/2004
fentanyl citrateLozenges0.2 mgACTIQ10/29/2004
fentanyl citrateLozenges0.4 mgACTIQ10/6/2004

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
8,802,130Sublingual buccal effervescent► Subscribe
6,350,470 Effervescent drug delivery system for oral administration► Subscribe
7,858,121Effervescent oral fentanyl dosage form and methods of administering fentanyl► 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
6,764,696 Effervescent drug delivery system for oral administration► Subscribe
6,576,250 Pharmaceutical compositions for rectal and vaginal administration► Subscribe
8,298,577Effervescent oral opiate dosage forms and methods of administering opiates► Subscribe
6,641,838 Effervescent drug delivery system for oral administration► 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
European Patent Office2271315► Subscribe
South Korea20060127944► Subscribe
Hong Kong1100166► Subscribe
European Patent Office1863452► Subscribe
Taiwan200637614► Subscribe
Denmark1082106► Subscribe
Norway20063429► Subscribe
Japan5685610► Subscribe
Canada2335566► Subscribe
South Korea20010031938► 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
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
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
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
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
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
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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 leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Fuji
Healthtrust
Baxter
Farmers Insurance
Cerilliant
Boehringer Ingelheim
US Army
McKinsey

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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