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Last Updated: March 7, 2021

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Cephalon Company Profile

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Summary for Cephalon

Drugs and US Patents for Cephalon

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;ORAL 020646-004 Sep 30, 1997 DISCN No No   Start Trial   Start Trial
Cephalon TREANDA bendamustine hydrochloride SOLUTION;IV (INFUSION) 022249-004 Sep 13, 2013 DISCN Yes No 8,791,270*PED   Start Trial Y   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-001 Jun 15, 2007 AB RX Yes No 7,297,346*PED   Start Trial Y   Start Trial
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-002 May 1, 2009 RX Yes Yes 8,609,863*PED   Start Trial Y   Start Trial
Cephalon TREANDA bendamustine hydrochloride SOLUTION;IV (INFUSION) 022249-003 Sep 13, 2013 DISCN Yes No 8,445,524*PED   Start Trial Y   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-003 Sep 30, 1997 AB RX Yes No   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 RX Yes No 7,862,833   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Cephalon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-002 Mar 26, 2009 4,927,855*PED   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 RE37516*PED   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-002 Sep 30, 1997 5,958,951   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-005 Apr 16, 1999 5,010,090   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 8,728,441   Start Trial
Cephalon NUVIGIL armodafinil TABLET;ORAL 021875-005 Mar 26, 2009 4,927,855*PED   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-003 Nov 4, 1998 4,671,953   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for CEPHALON drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Lozenges 0.8 mg, 1.2 mg and 1.6 mg ➤ Subscribe 2004-11-22
➤ Subscribe Injection 1 mg/mL ➤ Subscribe 2015-08-11
➤ Subscribe Injection 90 mg/mL, 0.5 mL and 2 mL in single-dose vials ➤ Subscribe 2014-06-19
➤ Subscribe Tablets 2 mg and 4 mg ➤ Subscribe 2005-02-01
➤ Subscribe Tablets 50 mg, 150 mg and 250 mg ➤ Subscribe 2009-07-24
➤ Subscribe Lozenges 0.2 mg ➤ Subscribe 2004-10-29
➤ Subscribe Lozenges 0.6 mg ➤ Subscribe 2004-12-20
➤ Subscribe Injection 25 mg/vial and 100 mg/vial ➤ Subscribe 2013-06-04
➤ Subscribe Buccal Tablets 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg ➤ Subscribe 2007-11-13
➤ Subscribe Tablets 12 mg and 16 mg ➤ Subscribe 2014-01-24
➤ Subscribe Tablets 100 mg and 200 mg ➤ Subscribe 2009-09-11
➤ Subscribe Lozenges 0.4 mg ➤ Subscribe 2004-10-06

Supplementary Protection Certificates for Cephalon Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0975367 122011000009 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0383579 C960030 Netherlands   Start Trial PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
1635783 122014000024 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783 C300653 Netherlands   Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0236342 SPC/GB98/022 United Kingdom   Start Trial PRODUCT 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
1635783 CA 2014 00016 Denmark   Start Trial PRODUCT 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
0836511 CA 2006 00019 Denmark   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORID
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Baxter
McKesson
Medtronic
Dow

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