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Bristol Company Profile

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

BRISTOL has one hundred and nine approved drugs.

There are twenty-four US patents protecting BRISTOL drugs.

There are seven hundred and thirty-four patent family members on BRISTOL drugs in fifty-nine countries and two hundred and twenty-four supplementary protection certificates in fifteen countries.

Summary for Bristol

International Patents:	734
US Patents:	24
Tradenames:	86
Ingredients:	73
NDAs:	109
Drug Master File Entries:	1
Patent Litigation for Bristol:	See patent lawsuits for Bristol
PTAB Cases with Bristol as patent owner:	See PTAB cases with Bristol as patent owner

Drugs and US Patents for Bristol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006		RX	Yes	No	6,596,746*PED				Y
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		RX	Yes	No	8,642,025		Y	Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006		RX	Yes	No	7,491,725*PED				Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006		RX	Yes	No	8,680,103*PED				Y
Bristol-myers Squibb	EVOTAZ	atazanavir sulfate; cobicistat	TABLET;ORAL	206353-001	Jan 29, 2015		RX	Yes	Yes	8,148,374		Y	Y
Bristol	CEPHALOTHIN SODIUM	cephalothin sodium	INJECTABLE;INJECTION	062464-003	May 7, 1984		DISCN	No	No
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-005	Dec 22, 1994		DISCN	Yes	No

Expired US Patents for Bristol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	MONOPRIL-HCT	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	020286-001	Nov 30, 1994	4,337,201*PED
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	TABLET;ORAL	018731-004	Apr 22, 1996	4,258,027
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,633,169
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993	5,180,589*PED
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	TABLET;ORAL	018731-002	Sep 29, 1986	5,015,646*PED
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET, TABLET, TABLET;ORAL	021387-001	Jun 24, 2003	4,346,227*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998	5,519,021*PED

Paragraph IV (Patent) Challenges for BRISTOL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	300 mg		2009-07-20
	Capsules	200 mg		2010-02-16
	Capsules	50 mg, 100 mg and 200 mg		2016-11-03
	Tablets	0.5 mg and 1 mg		2010-06-14
	Tablets	30 mg		2005-06-01
	Tablets	80 mg and 140 mg		2011-06-16
	Delayed-release Capsules	200 mg, 250 mg and 400 mg		2004-06-01
	Capsules	100 mg and 150 mg		2010-03-19
	Tablets	600 mg		2009-04-09
	Nasal Spray	4 mg/spray		2016-07-15
	Tablets	2.5 mg and 5 mg		2016-12-28
	Tablets	20 mg, 50 mg, 70 mg and 100 mg		2010-06-28
	Tablets	80 mg and 140 mg		2011-06-17

International Patents for Bristol Drugs

Country	Document Number	Estimated Expiration
African Regional IP Organization (ARIPO)	1224
Norway	2011021
New Zealand	583148
Denmark	1711481
Japan	2003528905
Poland	204263
Brazil	0009721

Supplementary Protection Certificates for Bristol Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2017	Austria		PRODUCT NAME: INSULIN GLARGIN UND LIXISENATID; REGISTRATION NO/DATE: EU/1/16/1157 (MITTEILUNG) 20170113
0885961/01	Switzerland		PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
C0035	France		PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
0880	Netherlands		PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
91020-8 0090020-9	Sweden		PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
0567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
90027-1	Sweden		PRODUCT NAME: AZTREONAMLYSIN; REG. NO/DATE: EU/1/09/543/01 20090921

Similar Applicant Names

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

• Bristol
• Bristol Myers
• Bristol Myers Squibb
• Bristol-myers Squibb