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Cephalon Company Profile

CEPHALON has eight approved drugs.

There are twenty-six US patents protecting CEPHALON drugs.

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

International Patents:	281
US Patents:	26
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	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-001	Oct 4, 1993		DISCN	No	No		➤ Sign Up				➤ Sign Up
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-003	Sep 13, 2013		DISCN	Yes	No	8,791,270*PED	➤ Sign Up			Y	➤ Sign Up
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	AB	RX	Yes	No	7,132,570*PED	➤ Sign Up			Y	➤ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	AB	RX	Yes	No		➤ 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	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997	5,010,090	➤ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	5,866,590	➤ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997	5,354,760	➤ Sign Up
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	4,177,290	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Country	Document Number	Estimated Expiration
Cyprus	1109176	➤ Sign Up
World Intellectual Property Organization (WIPO)	2005065317	➤ Sign Up
Mexico	2011002936	➤ Sign Up
Austria	433745	➤ Sign Up
Country	Document Number	Estimated Expiration

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00653	Netherlands	➤ Sign Up	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00521	Netherlands	➤ Sign Up	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
C0107	Belgium	➤ Sign Up	PRODUCT NAME: TIAGABINE CHLORHYDRATE MONOHYDRATE - TIAGABINE ANHYDRE; NAT. REGISTRATION NO/DATE: 403 IS 102 F 3 19970602; FIRST REGISTRATION: FR 341 260.2 19960614
C/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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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