FDA Orange Book · active-ingredient family
Imatinib mesylate
Imatinib mesylate: 3 brands, 16 generics; first approved May 10, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
16
Listed patents
1
Next patent expiry
Apr 27, 2040
in 13 yr 9 mo
Brand (NDA) products
Originator applications
- SHORLA ONCOLOGYNDA 2190972024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 80MG BASE/ML SOLUTION ORAL Rx - - NOVARTISNDA 02158820032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - GLEEVECRLDNOVARTISNDA 02133520012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Discontinued - EQ 100MG BASE CAPSULE ORAL Discontinued -
Generic (ANDA) products (16)
Abbreviated applications
- IMATINIB MESYLATECSPC OUYIANDA 21219320252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATEHETERO LABS LTD VANDA 21297520252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATEQILU PHARM HAINANANDA 21213520222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATEEUGIA PHARMAANDA 21277320202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATEZYDUS PHARMSANDA 21065820202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATENATCO PHARMA LTDANDA 20781820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATEAMNEAL PHARMSANDA 20749520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Discontinued - EQ 400MG BASE TABLET ORAL Discontinued - - IMATINIB MESYLATENOVITIUM PHARMAANDA 20599020192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Discontinued - EQ 400MG BASE TABLET ORAL Discontinued - - IMATINIB MESYLATECHARTWELL RXANDA 20842920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATESHILPAANDA 20830220192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATEDR REDDYSANDA 20654720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATEHIKMAANDA 20758620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Discontinued - EQ 400MG BASE TABLET ORAL Discontinued - - IMATINIB MESYLATEMYLANANDA 20464420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATEAPOTEXANDA 07917920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATETEVA PHARMS USAANDA 20428520162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB - IMATINIB MESYLATESUN PHARMANDA 07834020152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Discontinued - EQ 400MG BASE TABLET ORAL Discontinued -
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11957681 | in 13 yr 9 mo | Product |
Approval history
FDA approval span
First approval
25 yr 10 mo ago
Most recent approval
1 yr 6 mo ago
Approvals span 2001–2025 across 19 FDA applications.
Brand (NDA) 316%
Generic (ANDA) 1684%
Imatinib mesylate: 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.
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