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Last Updated: November 22, 2019

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ATAZANAVIR SULFATE Drug Profile

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When do Atazanavir Sulfate patents expire, and when can generic versions of Atazanavir Sulfate launch?

Atazanavir Sulfate is a drug marketed by Aurobindo Pharma Ltd, Cipla, Mylan, and Teva Pharms Usa. and is included in four NDAs.

The generic ingredient in ATAZANAVIR SULFATE is atazanavir sulfate. There are twenty-five drug master file entries for this compound. Ten suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the atazanavir sulfate profile page.

Drug patent expirations by year for ATAZANAVIR SULFATE
Drug Prices for ATAZANAVIR SULFATE

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Recent Clinical Trials for ATAZANAVIR SULFATE

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SponsorPhase
GlaxoSmithKlinePhase 4
ViiV HealthcarePhase 4

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Recent Litigation for ATAZANAVIR SULFATE

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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

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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
Aurobindo Pharma Ltd ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 204806-001 Jun 25, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 200626-003 Aug 9, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 204806-004 Jun 25, 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
Cipla ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 200626-004 Aug 9, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 091673-003 Apr 22, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ATAZANAVIR SULFATE atazanavir sulfate CAPSULE;ORAL 204806-002 Jun 25, 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

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