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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 ten approved drugs.

There are twenty-three US patents protecting BRISTOL drugs.

There are six hundred and fifty-four patent family members on BRISTOL drugs in fifty-eight countries and two hundred and eighteen supplementary protection certificates in fifteen countries.

Summary for Bristol

International Patents:	654
US Patents:	23
Tradenames:	87
Ingredients:	74
NDAs:	110
Drug Master File Entries:	1

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	ELIQUIS	apixaban	TABLET;ORAL	202155-002	Dec 28, 2012		RX	Yes	Yes	9,326,945		Y
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-002	Oct 31, 1991		DISCN	Yes	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006	AB	RX	Yes	No	7,125,875
Bristol	BETAPEN-VK	penicillin v potassium	TABLET;ORAL	061150-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for Bristol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-006	Oct 28, 1999	4,861,759*PED
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET, TABLET, TABLET;ORAL	021387-005	Jun 24, 2003	4,346,227*PED
Bristol Myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020155-005	Oct 9, 1991	4,861,759*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998	5,519,021*PED

Paragraph IV (Patent) Challenges for BRISTOL drugs

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

Non-Orange Book US Patents for Bristol

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
8,486,942	Modulators of pharmacokinetic properties of therapeutics
9,382,219	Cyclic protein tyrosine kinase inhibitors
8,716,323	Cyclic protein tyrosine kinase inhibitors
6,858,616	Nitrogen containing heterobicycles as factor Xa inhibitors

International Patents for Bristol Drugs

Country	Document Number	Estimated Expiration
Argentina	047533
Slovenia	1427415
Japan	2014088441
South Korea	20140004808

Supplementary Protection Certificates for Bristol Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
01C/001	Belgium		PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
/2005	Austria		PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
1304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014

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