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Generated: August 17, 2017
What is the competitive landscape for BRISTOL, and what generic alternatives to BRISTOL drugs are available?
BRISTOL has one hundred and ten approved drugs.| 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 | PRAVIGARD PAC (COPACKAGED) | aspirin; pravastatin sodium | TABLET, TABLET, TABLET;ORAL | 021387-004 | Jun 24, 2003 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bristol Myers Squibb | PROTAMINE ZINC INSULIN | insulin susp protamine zinc purified beef | INJECTABLE;INJECTION | 017928-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bristol Myers Squibb | GLUCOPHAGE | metformin hydrochloride | TABLET;ORAL | 020357-003 | Nov 5, 1998 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567-003 | Jun 20, 2003 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Bristol Myers Squibb | NARCAN | naloxone hydrochloride | INJECTABLE;INJECTION | 071083-001 | Jul 28, 1988 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| 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 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Bristol Myers Squibb | BUSPAR | buspirone hydrochloride | TABLET;ORAL | 018731-002 | Sep 29, 1986 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Bristol Myers Squibb | ZERIT | stavudine | CAPSULE;ORAL | 020412-002 | Jun 24, 1994 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-002 | Feb 1, 2002 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Bristol Myers Squibb | BUSPAR | buspirone hydrochloride | TABLET;ORAL | 018731-004 | Apr 22, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
apixaban | Tablets | 2.5 mg and 5 mg | ELIQUIS | 12/28/2016 |
naloxone hydrochloride | Nasal Spray | 4 mg/spray | NARCAN | 7/15/2016 |
dasatinib | Tablets | 80 mg and 140 mg | SPRYCEL | 6/17/2011 |
dasatinib | Tablets | 80 mg and 140 mg | SPRYCEL | 6/16/2011 |
dasatinib | Tablets | 20 mg, 50 mg, 70 mg and 100 mg | SPRYCEL | 6/28/2010 |
entecavir | Tablets | 0.5 mg and 1 mg | BARACLUDE | 6/14/2010 |
atazanavir sulfate | Capsules | 100 mg and 150 mg | REYATAZ | 3/19/2010 |
atazanavir sulfate | Capsules | 200 mg | REYATAZ | 2/16/2010 |
atazanavir sulfate | Capsules | 300 mg | REYATAZ | 7/20/2009 |
efavirenz | Tablets | 600 mg | SUSTIVA | 4/9/2009 |
pravastatin sodium | Tablets | 30 mg | PRAVACHOL | 6/1/2005 |
didanosine | Delayed-release Capsules | 200 mg, 250 mg and 400 mg | VIDEX EC | 6/1/2004 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,858,616 | Nitrogen containing heterobicycles as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 9,227,961 | Hepatitis C virus inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 8,188,120 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 7,371,761 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 6,989,391 | Lactam-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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Argentina | 061838 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2008010921 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 1610780 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2487168 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1427415 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB96/049 | United Kingdom | ► Subscribe | PRODUCT NAME: STAVUDINE; REGISTERED: UK EU/1/96/009/001 19960508; UK EU/1/96/009/002 19960508; UK EU/1/96/009/003 19960508; UK EU/1/96/009/004 19960508; UK EU/1/96/009/005 19960508; UK EU/1/96/009/006 19960508; UK EU/1/96/009/007 19960508; UK EU/1/96/009/008 19960508; UK EU/1/96/009/009 19960508 | ||||||||||||||||||||||||||
| /2016 | Austria | ► Subscribe | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123 | ||||||||||||||||||||||||||
| C0007 | France | ► Subscribe | PRODUCT NAME: DACLATASVIR ET DES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI,EN PARTICULIER LE SEL DE DICHLORHYDRATE DE DACLATASVIR; REGISTRATION NO/DATE: EU/1/14/939/001 20140826 | ||||||||||||||||||||||||||
| 213 | Luxembourg | ► Subscribe | PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE | ||||||||||||||||||||||||||
| C0004 | Belgium | ► Subscribe | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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