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-seven patent family members on CEPHALON drugs in thirty-five countries and fourteen supplementary protection certificates in five countries.

International Patents:	237
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	SOLUTION;IV (INFUSION)	022249-003	Sep 13, 2013		DISCN	Yes	No	8,445,524*PED	See Plans and Pricing			Y	See Plans and Pricing
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-002	Oct 4, 1993		DISCN	No	No		See Plans and Pricing				See Plans and Pricing
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		RX	Yes	No	7,862,832	See Plans and Pricing	Y			See Plans and Pricing
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-004	Sep 13, 2013		DISCN	Yes	No	8,791,270*PED	See Plans and Pricing			Y	See Plans and Pricing
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	Jun 15, 2007	AB	RX	Yes	No	7,132,570*PED	See Plans and Pricing			Y	See Plans and Pricing
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		RX	Yes	No	8,119,158	See Plans and Pricing	Y			See Plans and Pricing
>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	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-001	Oct 4, 1993	4,671,953	See Plans and Pricing
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-002	Oct 4, 1993	4,671,953	See Plans and Pricing
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-005	Nov 4, 1998	4,671,953	See Plans and Pricing
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	4,927,855*PED	See Plans and Pricing
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998	4,863,737	See Plans and Pricing
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	4,927,855*PED	See Plans and Pricing
>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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Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	200501016	See Plans and Pricing
South Korea	20180056804	See Plans and Pricing
European Patent Office	2271315	See Plans and Pricing
Canada	2549642	See Plans and Pricing
South Africa	200504805	See Plans and Pricing
Canada	2548915	See Plans and Pricing
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0236342	SPC/GB98/022	United Kingdom	See Plans and Pricing	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	See Plans and Pricing	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
1769785	C300521	Netherlands	See Plans and Pricing	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783	300653	Netherlands	See Plans and Pricing	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511	SPC/GB06/022	United Kingdom	See Plans and Pricing	PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
0836511	122006000022	Germany	See Plans and Pricing	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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