Is there a generic Gleevec?

16 companies list imatinib mesylate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.

Who supplies imatinib mesylate active ingredient?

12 companies list imatinib mesylate as a bulk ingredient, including LAURUS LABS LIMITED, MSN Laboratories Private Limited,, Aurobindo Pharma Limited, Darmerica, LLC.

Drug

Who makes imatinib mesylate?

18 companies list imatinib mesylate as a human prescription drug, including under the names Gleevec. Forms: tablet; tablet, film coated. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing imatinib mesylate

Company	Forms	Application	NDCs	Registered sites
BluePoint Laboratories Inc.	tablet, film coated	ANDAANDA078340, ANDA212773	4	0
Novartis Pharmaceuticals CorporationSwitzerland	tablet	NDANDA021588	3	20
Sun Pharmaceutical Industries LimitedIndia	tablet, film coated	ANDAANDA078340	2	13
Apotex Inc.Canada	tablet, film coated	ANDAANDA079179	2	6
Aurobindo Pharma LimitedIndia	tablet, film coated	ANDAANDA212773	2	6
Teva Pharmaceutical Industries Ltd.Canada	tablet, film coated	ANDAANDA204285	2	6
Qilu Pharmaceutical Co., Ltd.China	tablet	ANDAANDA212135	2	5
Camber Pharmaceuticals, Inc.United States	tablet, film coated	ANDAANDA212975	2	1
ASCEND Therapeutics US, LLC	tablet, film coated	ANDAANDA208302	2	0
Archis Pharma LLC	tablet	ANDAANDA212135	2	0
Armas Pharmaceuticals, Inc.	tablet, film coated	ANDAANDA208302	2	0
Chartwell RX, LLC.	tablet, film coated	ANDAANDA208429	2	0
Civica Script LLC	tablet, film coated	ANDAANDA212975	2	0
MAJOR Pharmaceuticals Inc.	tablet, film coated	ANDAANDA079179	2	0
Novartis Pharma Produktions GmbH	tablet	DRUG FOR FURTHER PROCESSING	2	0
Quallent Pharmaceuticals Health, LLC	tablet, film coated	ANDAANDA212773	2	0
Upsher-Smith Laboratories, Inc.	tablet	ANDAANDA212135	2	0
Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States	tablet, film coated	ANDAANDA079179	1	5

Bulk ingredient listings

LAURUS LABS LIMITEDIndia · 2 NDC
MSN Laboratories Private Limited,India · 2 NDC
Aurobindo Pharma LimitedIndia · 1 NDC
Darmerica, LLCUnited States · 1 NDC
Dr. Reddy's Laboratories LimitedIndia · 1 NDC
Hubei Biocause Heilen Pharmaceutical Co., LtdChina · 1 NDC
Sterling Pharmaceutical Services, LLCUnited States · 1 NDC
Sun Pharmaceutical Industries LimitedIndia · 1 NDC
TAPI Croatia industries d.o.o.Croatia · 1 NDC
Valary Lab Private LimitedIndia · 1 NDC
Zhejiang Ausun Pharmaceutical Co., Ltd.China · 1 NDC
Zhejiang Jiuzhou Pharmaceutical Co., Ltd.China · 1 NDC

Orange Book patents

1 unexpired patent lists imatinib mesylate as the active ingredient, expiring between Apr 2040 and Apr 2040. Application holder: SHORLA ONCOLOGY.

Enquiry

Common questions

Who makes imatinib mesylate?: 18 companies list imatinib mesylate as a human prescription drug in the openFDA NDC Directory, led by BluePoint Laboratories Inc., Novartis Pharmaceuticals Corporation, Sun Pharmaceutical Industries Limited, Apotex Inc., Aurobindo Pharma Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic Gleevec?: 16 companies list imatinib mesylate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies imatinib mesylate active ingredient?: 12 companies list imatinib mesylate as a bulk ingredient, including LAURUS LABS LIMITED, MSN Laboratories Private Limited,, Aurobindo Pharma Limited, Darmerica, LLC.