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CEPHALON Company Profile

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CEPHALON has eight approved drugs.

There are twenty US patents protecting CEPHALON drugs.

There are two hundred and sixty-seven patent family members on CEPHALON drugs in thirty-five countries and fourteen supplementary protection certificates in five countries.

International Patents:	267
US Patents:	20
Tradenames:	8
Ingredients:	6
NDAs:	8
Patent Litigation for CEPHALON:	See patent lawsuits for CEPHALON
PTAB Cases with CEPHALON as patent owner:	See PTAB cases with CEPHALON as patent owner

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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)	022249-001	Mar 20, 2008		RX	Yes	Yes	8,436,190*PED	Start Trial			Y	Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		RX	Yes	No	8,765,100	Start Trial	Y			Start Trial
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008		RX	Yes	Yes	8,609,863*PED	Start Trial			Y	Start Trial
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	Jun 15, 2007	AB	RX	Yes	No	7,297,346*PED	Start Trial			Y	Start Trial
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-006	Nov 4, 1998	AB	RX	Yes	No		Start Trial				Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		RX	Yes	No	6,200,604	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-005	Nov 4, 1998	4,671,953	Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006	8,728,441	Start Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997	5,010,090	Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006	8,753,611	Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006	6,974,590	Start Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	5,958,951	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	100 mg and 200 mg	➤ Subscribe	2009-09-11
➤ Subscribe	Lozenges	0.4 mg	➤ Subscribe	2004-10-06
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0836511	122006000022	Germany	Start Trial	PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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
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
1769785	C300522	Netherlands	Start Trial	PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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