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Cephalon Company Profile

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What is the competitive landscape for CEPHALON, and what generic alternatives to CEPHALON drugs are available?

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	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-004	Sep 13, 2013		DISCN	Yes	No	8,344,006*PED				Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	RX	Yes	Yes	8,609,863*PED				Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009	AP	RX	Yes	Yes	8,445,524*PED				Y
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017		RX	Yes	Yes	8,273,379
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	RX	Yes	Yes	8,436,190*PED				Y
Cephalon	TRISENOX	arsenic trioxide	INJECTABLE;INJECTION	021248-002	Oct 13, 2017		RX	Yes	Yes	6,861,076

Expired US Patents for Cephalon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009	RE37516*PED
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	5,866,590
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	5,866,590
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997	5,958,951
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-003	Nov 4, 1998	4,863,737
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	5,010,090

Paragraph IV (Patent) Challenges for CEPHALON drugs

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

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
8,975,442	Process for the preparation of and crystalline forms of optical enantiomers of modafinil
6,770,304	Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
7,879,364	Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
6,350,470	Effervescent drug delivery system for oral administration
7,858,121	Effervescent oral fentanyl dosage form and methods of administering fentanyl
6,641,838	Effervescent drug delivery system for oral administration

International Patents for Cephalon Drugs

Country	Document Number	Estimated Expiration
China	1285743
South Africa	200705793
Egypt	24849
Australia	1397399
Spain	2325860
Cyprus	1114291

Supplementary Protection Certificates for Cephalon Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
00522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
00521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
2006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126

Similar Applicant Names

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

• Ceph Intl
• Cephalon
• Cephazone Pharma