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

International Patents:	238
US Patents:	15
Tradenames:	8
Ingredients:	6
NDAs:	8
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	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	AB	RX	Yes	No		⤷ Sign Up				⤷ Sign Up
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-002	May 1, 2009	AP	RX	Yes	Yes	8,669,279*PED	⤷ Sign Up			Y	⤷ Sign Up
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	022249-004	Sep 13, 2013		DISCN	Yes	No	8,445,524*PED	⤷ Sign Up			Y	⤷ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997	AB	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009		DISCN	Yes	No	7,132,570*PED	⤷ Sign Up				⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		DISCN	Yes	No	7,862,832	⤷ Sign Up	Y			⤷ Sign Up
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	AP	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
>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	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006	8,765,100	⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-004	Jun 15, 2007	7,297,346*PED	⤷ Sign Up
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017	6,723,351	⤷ Sign Up
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	4,177,290	⤷ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997	5,958,951	⤷ Sign Up
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-007	Oct 30, 1995	4,671,953	⤷ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	Jun 15, 2007	7,132,570*PED	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Injection	25 mg/vial and 100 mg/vial	➤ Subscribe	2013-06-04

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	02096401	⤷ Sign Up
Japan	4719471	⤷ Sign Up
Eurasian Patent Organization	008506	⤷ Sign Up
South Korea	20170096221	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005065318	⤷ Sign Up
Austria	E498395	⤷ Sign Up
China	104224703	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300522	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0836511	SPC/GB06/022	United Kingdom	⤷ Sign Up	PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783	CA 2014 00016	Denmark	⤷ Sign Up	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
0236342	SPC/GB98/022	United Kingdom	⤷ Sign Up	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	122014000024	Germany	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783	300653	Netherlands	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: FENTANYL HYDROCHLORID
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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