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Cephalon Company Profile

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What is the competitive landscape for CEPHALON, and when can generic versions of CEPHALON drugs launch?

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.

Summary for Cephalon

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

Drugs and US Patents for Cephalon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017		RX	Yes	Yes	6,884,439
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997		DISCN	No	No
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-001	Sep 25, 2000		RX	Yes	Yes	6,884,439
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	AB	RX	Yes	No

Expired US Patents for Cephalon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999	5,958,951
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	RE37516*PED
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998	4,671,953
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998	5,785,989

Paragraph IV (Patent) Challenges for CEPHALON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Buccal Tablets	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg		2007-11-13
	Lozenges	0.4 mg		2004-10-06
	Lozenges	0.8 mg, 1.2 mg and 1.6 mg		2004-11-22
	Tablets	50 mg, 150 mg and 250 mg		2009-07-24
	Injection	25 mg/vial and 100 mg/vial		2013-06-04
	Injection	90 mg/mL, 0.5 mL and 2 mL in single-dose vials		2014-06-19
	Lozenges	0.2 mg		2004-10-29
	Lozenges	0.6 mg		2004-12-20
	Tablets	2 mg and 4 mg		2005-02-01
	Tablets	100 mg and 200 mg		2009-09-11
	Tablets	12 mg and 16 mg		2014-01-24
	Injection	1 mg/mL		2015-08-11

Non-Orange Book US Patents for Cephalon

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,576,250	Pharmaceutical compositions for rectal and vaginal administration
6,764,696	Effervescent drug delivery system for oral administration
8,802,130	Sublingual buccal effervescent
6,350,470	Effervescent drug delivery system for oral administration

International Patents for Cephalon Drugs

Country	Document Number	Estimated Expiration
Canada	2724305
Japan	2013056901
Denmark	1419765
Malaysia	142926

Supplementary Protection Certificates for Cephalon Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
C/GB98/022	United Kingdom		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
2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Ceph Intl
• Cephalon
• Cephazone Pharma