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Cephalon Company Profile

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CEPHALON has eight approved drugs.

There are fifteen US patents protecting CEPHALON drugs.

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

International Patents:	235
US Patents:	15
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)	022249-002	May 1, 2009		RX	Yes	Yes	8,436,190*PED	Start Trial			Y	Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		RX	Yes	No	7,862,832	Start Trial	Y			Start Trial
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009		DISCN	Yes	No	7,132,570*PED	Start Trial			Y	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	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		RX	Yes	Yes	7,862,832	Start Trial	Y			Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		RX	Yes	No	8,092,832	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997	5,958,951	Start Trial
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998	4,863,737	Start Trial
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	4,927,855*PED	Start Trial
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006	8,728,441	Start Trial
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	Jun 15, 2007	RE37516*PED	Start Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997	5,866,590	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Country	Patent Number	Estimated Expiration
Australia	2004311879	Start Trial
Eurasian Patent Organization	200500486	Start Trial
Norway	20073722	Start Trial
China	102078305	Start Trial
Mexico	PA05002832	Start Trial
Norway	20063429	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0901368	C300523	Netherlands	Start Trial	PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0236342	97C0107	Belgium	Start Trial	PRODUCT NAME: TIAGABINE CHLORHYDRATE MONOHYDRATE - TIAGABINE ANHYDRE; NAT. REGISTRATION NO/DATE: 403 IS 102 F 3 19970602; FIRST REGISTRATION: FR 341 260.2 19960614
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
1635783	300653	Netherlands	Start Trial	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511	CA 2006 00019	Denmark	Start Trial	PRODUCT NAME: FENTANYL HYDROCHLORID
0836511	122006000022	Germany	Start Trial	PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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