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Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
Healthtrust
UBS
McKinsey
Boehringer Ingelheim
Farmers Insurance
Baxter
Deloitte
Novartis

Generated: October 21, 2017

DrugPatentWatch Database Preview

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-four US patents protecting BRISTOL drugs and there have been three Paragraph IV challenges on BRISTOL drugs in the past three years.

There are six hundred and sixty-three patent family members on BRISTOL drugs in fifty-eight countries and one hundred and ninety-eight supplementary protection certificates in fifteen countries.

Summary for Applicant: Bristol

International Patents:663
US Patents:24
Tradenames:87
Ingredients:74
NDAs:110
Drug Master File Entries: (click here to view)1
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
REYATAZ
atazanavir sulfate
POWDER;ORAL206352-001Jun 2, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
DROXIA
hydroxyurea
CAPSULE;ORAL016295-003Feb 25, 1998RXYesNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
VIDEX EC
didanosine
CAPSULE, DELAYED REL PELLETS;ORAL021183-003Oct 31, 2000ABRXYesNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
BLENOXANE
bleomycin sulfate
INJECTABLE;INJECTION050443-002Sep 7, 1995DISCNYesNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-005Oct 28, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
OXYCODONE 5/APAP 500
acetaminophen; oxycodone hydrochloride
TABLET;ORAL085911-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
MONOPRIL-HCT
fosinopril sodium; hydrochlorothiazide
TABLET;ORAL020286-001Nov 30, 1994DISCNYesNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
ZERIT
stavudine
CAPSULE;ORAL020412-002Jun 24, 1994ABRXYesNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
PRAVIGARD PAC (COPACKAGED)
aspirin; pravastatin sodium
TABLET, TABLET, TABLET;ORAL021387-002Jun 24, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
RAU-SED
reserpine
TABLET;ORAL009357-006Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Bristol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-004Mar 22, 1993► Subscribe► Subscribe
Bristol Myers Squibb
VIDEX EC
didanosine
CAPSULE, DELAYED REL PELLETS;ORAL021183-003Oct 31, 2000► Subscribe► Subscribe
Bristol Myers Squibb
VIDEX
didanosine
TABLET, CHEWABLE;ORAL020154-003Oct 9, 1991► Subscribe► Subscribe
Bristol Myers Squibb
BARACLUDE
entecavir
TABLET;ORAL021797-002Mar 29, 2005► Subscribe► Subscribe
Bristol Myers Squibb
PRAVACHOL
pravastatin sodium
TABLET;ORAL019898-008Dec 18, 2001► Subscribe► Subscribe
Bristol Myers Squibb
BUSPAR
buspirone hydrochloride
TABLET;ORAL018731-003Apr 22, 1996► Subscribe► Subscribe
Bristol Myers Squibb
PRAVIGARD PAC (COPACKAGED)
aspirin; pravastatin sodium
TABLET, TABLET, TABLET;ORAL021387-001Jun 24, 2003► Subscribe► Subscribe
Bristol Myers Squibb
VIDEX
didanosine
FOR SOLUTION;ORAL020155-005Oct 9, 1991► Subscribe► Subscribe
Bristol Myers Squibb
VIDEX
didanosine
TABLET, CHEWABLE;ORAL020154-003Oct 9, 1991► Subscribe► Subscribe
Bristol Myers Squibb
ZERIT
stavudine
CAPSULE;ORAL020412-001Jun 24, 1994► Subscribe► Subscribe
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Paragraph IV activity for BRISTOL drugs

Drugname Dosage Strength Tradename Submissiondate
apixaban
Tablets2.5 mg and 5 mg
ELIQUIS
12/28/2016
efavirenz
Capsules50 mg, 100 mg and 200 mg
SUSTIVA 
11/3/2016
naloxone hydrochloride
Nasal Spray4 mg/spray
NARCAN
7/15/2016
dasatinib
Tablets80 mg and 140 mg
SPRYCEL
6/17/2011
dasatinib
Tablets80 mg and 140 mg
SPRYCEL
6/16/2011
dasatinib
Tablets20 mg, 50 mg, 70 mg and 100 mg
SPRYCEL
6/28/2010
entecavir
Tablets0.5 mg and 1 mg
BARACLUDE
6/14/2010
atazanavir sulfate
Capsules100 mg and 150 mg
REYATAZ
3/19/2010
atazanavir sulfate
Capsules200 mg
REYATAZ
2/16/2010
atazanavir sulfate
Capsules300 mg
REYATAZ
7/20/2009
efavirenz
Tablets600 mg
SUSTIVA
4/9/2009
pravastatin sodium
Tablets30 mg
PRAVACHOL
6/1/2005
didanosine
Delayed-release Capsules200 mg, 250 mg and 400 mg
VIDEX EC
6/1/2004

Non-Orange Book 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
6,673,810 Imidazo-heterobicycles as factor Xa inhibitors► Subscribe
7,005,435Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
6,989,391Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
5,965,729 Process for the crystallization of a reverse transcriptase inhibitor using an anti-solvent► Subscribe
7,371,761Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
6,110,946 Antivirally active heterocyclic azahexane derivatives► Subscribe
7,939,553Modulators of pharmacokinetic properties of therapeutics► Subscribe
7,091,223Cyclic protein tyrosine kinase inhibitors► Subscribe
8,188,120Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
7,531,535Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Bristol Drugs

Country Document Number Estimated Expiration
European Patent Office2385048► Subscribe
Cyprus1118232► Subscribe
Poland334478► Subscribe
Cyprus1116688► Subscribe
Austria439360► Subscribe
Slovenia2487163► Subscribe
Australia2005304863► Subscribe
Luxembourg92864► Subscribe
Israel144910► Subscribe
Spain2181417► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Bristol Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
00597Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
401Luxembourg► SubscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
2013025,C1304992Lithuania► SubscribePRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
C0005Belgium► SubscribePRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
11/032Ireland► SubscribePRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
888Luxembourg► Subscribe91888, EXPIRES: 20260518
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
AstraZeneca
Baxter
Healthtrust
QuintilesIMS
Boehringer Ingelheim
Daiichi Sankyo
Farmers Insurance
McKinsey
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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