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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
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	BARACLUDE	entecavir	TABLET;ORAL	021797-002	Mar 29, 2005	AB	RX	Yes	Yes
Bristol Myers Squibb	AMITID	amitriptyline hydrochloride	TABLET;ORAL	086454-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol	TETREX	tetracycline phosphate complex	CAPSULE;ORAL	061653-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol	TETREX	tetracycline phosphate complex	CAPSULE;ORAL	061653-003	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	MONOPRIL	fosinopril sodium	TABLET;ORAL	019915-004	Mar 28, 1995	4,384,123
Bristol Myers Squibb	VIDEX EC	didanosine	CAPSULE, DELAYED REL PELLETS;ORAL	021183-002	Oct 31, 2000	5,254,539*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998	5,811,423
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET, TABLET, TABLET;ORAL	021387-003	Jun 24, 2003	4,346,227*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
6,979,694	Cyclic protein tyrosine kinase inhibitors
8,470,854	Lactam-containing compounds and derivatives thereof as factor XA inhibitors
7,338,963	Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
9,758,487	Hepatitis C virus inhibitors

International Patents for Bristol Drugs

Country	Document Number	Estimated Expiration
Taiwan	200904419
China	1980909
Slovakia	12822002
Brazil	9908911

Supplementary Protection Certificates for Bristol Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2015040,C2049506	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
C0046	Belgium		PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624
60026	Netherlands		PRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430

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