Generic Retevmo Availability

Last updated on Apr 10, 2025.

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

RETEVMO (selpercatinib - capsule;oral)

Manufacturer: ELI LILLY AND CO
Approval date: May 8, 2020
Strength(s): 40MG ^[RLD], 80MG ^[RLD]

RETEVMO (selpercatinib - tablet;oral)

Manufacturer: ELI LILLY AND CO
Approval date: April 10, 2024
Strength(s): 40MG ^[RLD], 80MG ^[RLD], 120MG ^[RLD], 160MG ^[RLD]

Is there a generic version of Retevmo available?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Retevmo. 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.

Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Patent 10,112,942
Issued: October 30, 2018
Inventor(s): Andrews Steven W. & Aronow Sean & Blake James F. & Brandhuber Barbara J. & Cook Adam & Haas Julia & Jiang Yutong & Kolakowski Gabrielle R. & McFaddin Elizabeth A. & McKenney Megan L. & McNulty Oren T. & Metcalf Andrew T. & Moreno David A. & Tang Tony P. & Ren Li
Assignee(s): Array BioPharma Inc.
Provided herein are compounds of the Formula I:
Patent expiration dates:
- October 10, 2037
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Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Patent 10,137,124
Issued: November 27, 2018
Inventor(s): Andrews Steven W. & Aronow Sean & Blake James F. & Brandhuber Barbara J. & Cook Adam & Haas Julia & Jiang Yutong & Kolakowski Gabrielle R. & McFaddin Elizabeth A. & McKenney Megan L. & McNulty Oren T. & Metcalf Andrew T. & Moreno David A. & Tang Tony P. & Ren Li
Assignee(s): Array BioPharma Inc.
Provided herein are compounds of the Formula I:
Patent expiration dates:
- October 10, 2037
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  Patent use: TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
- October 10, 2037
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  Patent use: ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
- October 10, 2037
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  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
- October 10, 2037
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  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
Patent 10,172,851
Issued: January 8, 2019
Inventor(s): Andrews Steven W. & Aronow Sean & Blake James F. & Brandhuber Barbara J. & Cook Adam & Haas Julia & Jiang Yutong & Kolakowski Gabrielle R. & McFaddin Elizabeth A. & McKenney Megan L. & McNulty Oren T. & Metcalf Andrew T. & Moreno David A. & Tang Tony P. & Ren Li
Assignee(s): Array BioPharma Inc.
Provided herein are compounds of the Formula I:
Patent expiration dates:
- October 10, 2037
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  Patent use: TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
- October 10, 2037
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  Patent use: ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
- October 10, 2037
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  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
- October 10, 2037
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  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
Crystalline forms
Patent 10,584,124
Issued: March 10, 2020
Inventor(s): Metcalf Andrew T. & Fry David & McFaddin Elizabeth A. & Kolakowski Gabrielle R. & Haas Julia & Tang Tony P. & Jiang Yutong
Assignee(s): Array Biopharma Inc.
Provided herein are compound of Formula I-IV and pharmaceutically acceptable salts thereof which exhibit rearranged during transfection (RET) kinase inhibition. In particular, provided herein are novel crystalline forms of 4-(6-(4-((6-methoxypyridin-3-yl)methyl)piperazin-1-yl)pyridin-3-yl)-6-(1-methyl-1H-pyrazol-4-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile (Formula I), 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile (Formula II), 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-(6-methoxynicotinoyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile (Formula III), 6-(2-hydroxy-2-methylpropoxy)-4-(6-(4-hydroxy-4-(pyridin-2-ylmethyl)piperidin-1-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile (Formula IV), and pharmaceutically acceptable salts thereof, pharmaceutical compositions comprising the compounds, processes for making the compounds, and the use of the compounds in therapy. More particularly, the application relates to novel crystalline forms of Formula I-IV and pharmaceutically acceptable salts thereof useful in the treatment and prevention of diseases which can be treated with a RET kinase inhibitor, including RET-associated diseases and disorders.
Patent expiration dates:
- October 10, 2038
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  Patent use: TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
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  Drug substance
- October 10, 2038
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  Patent use: ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
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  Drug substance
- October 10, 2038
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  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
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  Drug substance
- October 10, 2038
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  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
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  Drug substance
Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-A]pyridine-3-carbonitrile
Patent 10,786,489
Issued: September 29, 2020
Inventor(s): Reynolds Mark & Eary Charles Todd
Assignee(s): Loxo Oncology Inc.
6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, or a pharmaceutically acceptable salt, amorphous form, polymorph form, or pharmaceutical composition (including solid formulations or liquid formulations) thereof and the use thereof for treating diseases and disorders which can be treated with a RET kinase inhibitor, such as RET-associated diseases and disorders, e.g., proliferative disorders such as cancers, including hematological cancers and solid tumors, and gastrointestinal disorders such as IBS are disclosed.
Patent expiration dates:
- October 10, 2038
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  Patent use: TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
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  Drug product
- October 10, 2038
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  Patent use: ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
  ✓
  Drug product
- October 10, 2038
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  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
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  Drug product
- October 10, 2038
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  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY
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  Drug product
Formulations of 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile
Patent 12,138,250
Issued: November 12, 2024
Inventor(s): Reynolds; Mark et al.
Assignee(s): Loxo Oncology, Inc. (Stanford, CT)
6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, or a pharmaceutically acceptable salt, amorphous form, polymorph form, or pharmaceutical composition (including solid formulations or liquid formulations) thereof and the use thereof for treating diseases and disorders which can be treated with a RET kinase inhibitor, such as RET-associated diseases and disorders, e.g., proliferative disorders such as cancers, including hematological cancers and solid tumors, and gastrointestinal disorders such as IBS are disclosed.
Patent expiration dates:
- October 10, 2038
  ✓
  Patent use: ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAS PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
- October 10, 2038
  ✓
  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY
- October 10, 2038
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  Patent use: TREATMENT OF ADULT OR PEDIATRIC PATIENTS 2 YEARS OF AGE OR OLDER WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY

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 8, 2025 - NEW CHEMICAL ENTITY
- May 8, 2027 - ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE)
- May 8, 2027 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)
- May 8, 2027 - INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY
- May 29, 2027 - NEW PATIENT POPULATION
- September 27, 2027 - REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-431
- September 27, 2027 - REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF STUDY LIBRETTO-531
- September 21, 2029 - TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAVE PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
- September 21, 2029 - TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST
- May 29, 2031 - TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WITH ADVANCED OR METASTATIC THYROID CANCER WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF
- May 29, 2031 - TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST, THAT HAVE PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTOR
- May 29, 2031 - TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WITH ADVANCED OR METASTATIC MEDULLARY THYROID CANCER (MTC) WITH A RET MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, WHO REQUIRE SYSTEMIC THERAPY

More about Retevmo (selpercatinib)

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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

User Reviews & Ratings

4 Reviews

Images

Pill Lilly 2980 80 mg is Retevmo 80 mg — Retevmo 80 mg (Lilly 2980 80 mg)