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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.

Summary for Bristol

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	VERSAPEN	hetacillin	FOR SUSPENSION;ORAL	061398-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol Myers Squibb	MEXATE-AQ PRESERVED	methotrexate sodium	INJECTABLE;INJECTION	089887-001	Apr 14, 1989		DISCN	No	No
Bristol	POLYCILLIN	ampicillin/ampicillin trihydrate	CAPSULE;ORAL	050310-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol	POLYCILLIN	ampicillin/ampicillin trihydrate	FOR SUSPENSION;ORAL	050308-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998	AB	RX	Yes	No	6,555,133*PED				Y

Expired US Patents for Bristol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-003	Dec 31, 2002	4,978,655*PED
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991	4,464,378
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET, TABLET;ORAL	021387-006	Jun 24, 2003	5,030,447*PED
Bristol-myers Squibb	VIDEX	didanosine	FOR SOLUTION;ORAL	020156-001	Oct 9, 1991	5,616,566*PED
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993	5,622,985*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
	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
	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

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
7,691,846	Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
8,574,563	Hepatitis C virus inhibitors
6,989,391	Lactam-containing compounds and derivatives thereof as factor Xa inhibitors
8,088,770	Modulators of pharmacokinetic properties of therapeutics
7,371,761	Lactam-containing compounds and derivatives thereof as factor Xa inhibitors

International Patents for Bristol Drugs

Country	Document Number	Estimated Expiration
Cyprus	1116852
Colombia	5560567
Hungary	E031707
Japan	2014088441
Peru	03782013

Supplementary Protection Certificates for Bristol Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
128	Luxembourg		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
13/034	Ireland		APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
C0006	Belgium		PRODUCT NAME: DIDANOSINE; NAT. REG.: 203 IS 225 F 3 19930331; FIRST REG.: FR 557 386-4 19920505
C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
11/032	Ireland		PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518

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