Generic Lumakras Availability

Last updated on Apr 10, 2025.

Lumakras is a brand name of sotorasib, approved by the FDA in the following formulation(s):

LUMAKRAS (sotorasib - tablet;oral)

Manufacturer: AMGEN INC
Approval date: May 28, 2021
Strength(s): 120MG ^[RLD]
Manufacturer: AMGEN INC
Approval date: January 20, 2023
Strength(s): 320MG ^[RLD]
Manufacturer: AMGEN INC
Approval date: June 26, 2024
Strength(s): 240MG ^[RLD]

Is there a generic version of Lumakras available?

No. There is currently no therapeutically equivalent version of Lumakras available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lumakras. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

KRAS G12C inhibitors and methods of using the same
Patent 10,519,146
Issued: December 31, 2019
Inventor(s): Lanman Brian Alan & Chen Jian & Reed Anthony B. & Cee Victor J. & Liu Longbin & Kopecky David John & Lopez Patricia & Wurz Ryan Paul & Nguyen Thomas T. & Booker Shon & Nishimura Nobuko & Shin Youngsook & Tamayo Nuria A. & Allen John Gordon & Allen Jennifer Rebecca
Assignee(s): Amgen Inc.
Provided herein are KRAS G12C inhibitors, composition of the same, and methods of using the same. These inhibitors are useful for treating a number of disorders, including pancreatic, colorectal, and lung cancers.
Patent expiration dates:
- May 21, 2038
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Solid state forms
Patent 11,236,091
Issued: February 1, 2022
Inventor(s): Chaves Mary & Lopez Patricia & Agarwal Prashant & Amegadzie Albert & Azali Stephanie & Shimanovich Roman & Kelly Ron C. & Reid Darren Leonard
Assignee(s): Amgen Inc.
The present disclosure provides crystalline and amorphous forms of 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-(4-methyl-2-(2-propanyl)-3-pyridinyl)-4-((2S)-2-methyl-4-(2-propenoyl)-1-piperazinyl)pyrido[2,3-d]pyrimidin-2(1H)-one, including several anhydrous, hydrate and solvate forms, and solid state forms thereof, pharmaceutical compositions, and methods of treating a disease mediated by KRAS G12C inhibition.
Patent expiration dates:
- May 20, 2040
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  Patent use: TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
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- May 20, 2040
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  Patent use: IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY
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KRAS
Patent 11,426,404
Issued: August 30, 2022
Inventor(s): Henary Haby & Lipford James Russell & Cee Victor J.
Assignee(s): Amgen Inc.
Provided herein are methods of administering a KRAS G12C inhibitor to a cancer subject.
Patent expiration dates:
- September 15, 2040
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  Patent use: TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
- September 15, 2040
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  Patent use: IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY
Solid state forms
Patent 11,827,635
Issued: November 28, 2023
Inventor(s): Chaves; Mary et al.
Assignee(s): Amgen Inc. (Thousand Oaks, CA)
The present disclosure provides crystalline and amorphous forms of 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-(4-methyl-2-(2-propanyl)-3-pyridinyl)-4-((2S)-2-methyl-4-(2-propenoyl)-1-piperazinyl)pyrido[2,3-d]pyrimidin-2(1H)-one, including several anhydrous, hydrate and solvate forms, and solid state forms thereof, pharmaceutical compositions, and methods of treating a disease mediated by KRAS G12C inhibition.
Patent expiration dates:
- May 20, 2040
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  Patent use: TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
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- May 20, 2040
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  Patent use: IN COMBINATION WITH PANITUMUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY
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Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- May 28, 2026 - NEW CHEMICAL ENTITY
- January 16, 2028 - IN COMBINATION WITH PANITUMUMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER AS DETERMINED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED PRIOR FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY
- May 28, 2028 - TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
- May 28, 2028 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
- January 16, 2032 - TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER (MCRC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED PRIOR FLUOROPYRIMIDINE-, OXALIPLATIN-AND IRINOTECAN-BASED CHEMOTHERAPY

More about Lumakras (sotorasib)

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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