FDA Orange Book · active-ingredient family
Abacavir sulfate
Abacavir sulfate: 2 brands, 8 generics; first approved Dec 17, 1998; 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
10
Brand (NDA) products
Originator applications
Generic (ANDA) products (8)
Abbreviated applications
- ABACAVIR SULFATEAUROBINDO PHARMA LTDANDA 0779502018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML SOLUTION ORAL Rx AA - ABACAVIR SULFATECIPLAANDA 0781192017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET ORAL Rx AB - ABACAVIR SULFATECHARTWELL RXANDA 0910502016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET ORAL Rx AB - ABACAVIR SULFATEHETERO LABS LTD IIIANDA 2011072016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/ML SOLUTION ORAL Rx AA - ABACAVIR SULFATERSHETERO LABS LTD IIIANDA 0915602013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET ORAL Rx AB - ABACAVIR SULFATEAPOTEX INCANDA 2015702012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET ORAL Discontinued — - ABACAVIR SULFATEAUROBINDO PHARMA LTDANDA 0778442012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET ORAL Rx AB - ABACAVIR SULFATEMYLAN PHARMS INCANDA 0912942012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE TABLET 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
28 yr 1 mo ago
Most recent approval
8 yr 7 mo ago
Approvals span 1998–2018 across 10 FDA applications.
Brand (NDA) 220%
Generic (ANDA) 880%
Abacavir 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.
