FDA Orange Book · active-ingredient family
Atazanavir sulfate
Atazanavir sulfate: 2 brands, 8 generics; first approved Jun 20, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
8
Listed patents
0
Presentations
33
Brand (NDA) products
Originator applications
- BRISTOL MYERS SQUIBBNDA 2063522014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/PACKET POWDER ORAL Rx — - REYATAZRLDBRISTOL MYERS SQUIBBNDA 02156720034 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — EQ 150MG BASE CAPSULE ORAL Discontinued — EQ 200MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB
Generic (ANDA) products (8)
Abbreviated applications
- ATAZANAVIR SULFATEHETERO LABS LTD IIIANDA 21227820223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB - ATAZANAVIR SULFATELAURUSANDA 21257920213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB - ATAZANAVIR SULFATEZYDUS PHARMSANDA 21057520203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued — EQ 200MG BASE CAPSULE ORAL Discontinued — EQ 300MG BASE CAPSULE ORAL Discontinued — - ATAZANAVIR SULFATEAMNEALANDA 20971720204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — EQ 150MG BASE CAPSULE ORAL Discontinued — EQ 200MG BASE CAPSULE ORAL Discontinued — EQ 300MG BASE CAPSULE ORAL Discontinued — - ATAZANAVIR SULFATEMYLANANDA 20817720183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE CAPSULE ORAL Discontinued — EQ 200MG BASE CAPSULE ORAL Discontinued — EQ 300MG BASE CAPSULE ORAL Discontinued — - ATAZANAVIR SULFATECIPLAANDA 20062620184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Discontinued — EQ 150MG BASE CAPSULE ORAL Discontinued — EQ 200MG BASE CAPSULE ORAL Discontinued — EQ 300MG BASE CAPSULE ORAL Discontinued — - ATAZANAVIR SULFATEAUROBINDO PHARMAANDA 20480620184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB - ATAZANAVIR SULFATETEVA PHARMS USAANDA 09167320144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE CAPSULE ORAL Rx AB EQ 150MG BASE CAPSULE ORAL Rx AB EQ 200MG BASE CAPSULE ORAL Rx AB EQ 300MG BASE CAPSULE ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
23 yr 6 mo ago
Most recent approval
4 yr 7 mo ago
Approvals span 2003–2022 across 10 FDA applications.
Brand (NDA) 220%
Generic (ANDA) 880%
Atazanavir sulfate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
