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Last Updated: November 13, 2019

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Atazanavir sulfate - Generic Drug Details

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What are the generic drug sources for atazanavir sulfate and what is the scope of freedom to operate?

Atazanavir sulfate is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Cipla, Mylan, Teva Pharms Usa, Bristol Myers Squibb, and Bristol-myers Squibb, and is included in seven NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Atazanavir sulfate has fifty-two patent family members in thirty-eight countries.

There are twenty-five drug master file entries for atazanavir sulfate. Ten suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for atazanavir sulfate

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Recent Clinical Trials for atazanavir sulfate

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SponsorPhase
ViiV HealthcarePhase 4
GlaxoSmithKlinePhase 4

See all atazanavir sulfate clinical trials

Recent Litigation for atazanavir sulfate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bristol-Myers Squibb Company v. Apotex Inc.2017-10-24
Bristol-Myers Squibb Company v. Cipla USA, Inc.2016-02-11
Bristol-Myers Squibb Company v. Mylan Pharmaceuticals, Inc.2015-03-19

See all atazanavir sulfate litigation

Generic filers with tentative approvals for ATAZANAVIR SULFATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MG/100MGTABLET; ORAL
  Start Trial  Start Trial200MGCAPSULE; ORAL
  Start Trial  Start Trial150MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for atazanavir sulfate
Synonyms for atazanavir sulfate
111996-EP2272516A2
111996-EP2298761A1
111996-EP2298783A1
2,5,6,10,13-Pentaazatetradecanedioic acid, 3-12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((-4-(2-pyridinyl)phenyl)methyl)-, dimethyl ester, (3S,8S,9S,12S)-, sulfate (1:1) (salt)
2,5,6,10,13-Pentaazatetradecanedioic acid, 3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-((4-(2-pyridinyl)phenyl)methyl)-, dimethyl ester, (3S,8S,9S,12S)-, sulfate (1:1) (salt)
229975-97-7
4MT4VIE29P
975A977
AB0015721
AC1L4K4Y
AK-97253
AKOS016000176
AOB5599
AS-14954
Atazanavir (sulfate)
Atazanavir sulfate (BMS-232632-05)
Atazanavir sulfate (JAN/USAN)
Atazanavir sulfate [USAN]
Atazanavir sulphate
atazanavir; sulfuric acid
BC677640
BMS-232632-05
C38H52N6O7.H2SO4
CHEBI:31243
CHEMBL1200678
CS-1890
D01276
Dimethyl (3S,8S,9S,12S)-9-benzyl-3,12,di-tert-butyl-8-hydroxy-4,11-dioxo-6-(p-2-pyridylbenzyl)-2,5,6,10,13-pentaazatetradecanedioate, sulfate (1:1) (salt)
DQSGVVGOPRWTKI-QVFAWCHISA-N
FT-0662312
HY-17367A
J-014934
KS-00000FO1
LS-186585
methyl ((5S,10S,11S,14S)-11-benzyl-5-(tert-butyl)-10-hydroxy-15,15-dimethyl-3,6,13-trioxo-8-(4-(pyridin-2-yl)benzyl)-2-oxa-4,7,8,12-tetraazahexadecan-14-yl)carbamate sulfate
methyl N-[(2S)-1-[2-[(2S,3S)-2-hydroxy-3-[[(2S)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate; sulfuric acid
methyl N-[(2S)-1-[2-[(2S,3S)-2-hydroxy-3-[[(2S)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-4-phenylbutyl]-2-[(4-pyridin-2-ylphenyl)methyl]hydrazinyl]-3,3-dimethyl-1-oxobutan-2-yl]carbamate;s
MLS003915641
MLS006010199
MolPort-016-633-312
N349
Reyataz
Reyataz (TN)
s1457
SB19157
SCHEMBL341700
SMR002544693
ST24030092
SW220258-1
ulfuric acid
UNII-4MT4VIE29P
Z-3316
Paragraph IV (Patent) Challenges for ATAZANAVIR SULFATE
Tradename Dosage Ingredient NDA Submissiondate
REYATAZ CAPSULE;ORAL atazanavir sulfate 021567 2010-03-19
REYATAZ CAPSULE;ORAL atazanavir sulfate 021567 2010-02-16
REYATAZ CAPSULE;ORAL atazanavir sulfate 021567 2009-07-20

US Patents and Regulatory Information for atazanavir sulfate

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;ORAL 206352-001 Jun 2, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 208177-003 Sep 24, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 091673-001 Apr 22, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 208177-002 Sep 24, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for atazanavir sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-004 Oct 16, 2006   Start Trial   Start Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-001 Jun 20, 2003   Start Trial   Start Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate CAPSULE;ORAL 021567-002 Jun 20, 2003   Start Trial   Start Trial
Bristol Myers Squibb REYATAZ atazanavir sulfate POWDER;ORAL 206352-001 Jun 2, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for atazanavir sulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487163 17C1000 France   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE SULFATE D'ATAZANAVIR; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2487163 93353 Luxembourg   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE SULFATE D'ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025
2487163 2016/062 Ireland   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTRATION NO/DATE: EU/1/15/1025 20160713
0900210 C00900210/01 Switzerland   Start Trial PRODUCT NAME: ATAZANAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56288 06.05.2004
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Dow
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