Generic Rytelo Availability
Last updated on May 7, 2025.
Rytelo is a brand name of imetelstat, approved by the FDA in the following formulation(s):
RYTELO (imetelstat sodium - powder;intravenous)
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Manufacturer: GERON
Approval date: June 6, 2024
Strength(s): EQ 47MG BASE/VIAL [RLD], EQ 188MG BASE/VIAL [RLD]
Is there a generic version of Rytelo available?
No. There is currently no therapeutically equivalent version of Rytelo available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Rytelo. 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.
See also: Generic Drug FAQ.
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.
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Methods of treating myelodysplastic syndrome
Patent 12,171,778
Issued: December 24, 2024
Inventor(s): Rizo; Aleksandra et al.
Assignee(s): Geron Corporation (Foster City, CA)This disclosure provides methods of treating a myelodysplastic syndrome (MDS) in a subject that is naive to treatment with an agent selected from a hypomethylating agent (HMA) and lenalidomide, or both. The method includes administering to the subject an effective amount of a telomerase inhibitor, such as e.g. imetelstat or imetelstat sodium. In some cases, the subject treated is classified as low or intermediate-1 IPSS risk MDS and/or have MDS relapsed/refractory to Erythropoiesis-Stimulating Agent (ESA).
Patent expiration dates:
- June 16, 2039✓
- June 16, 2039
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Modified oligonucleotides for telomerase inhibition
Patent 7,494,982
Issued: February 24, 2009
Inventor(s): Gryaznov; Sergei et al.
Assignee(s): Geron Corporation (Menlo Park, CA)Compounds comprising an oligonucleotide moiety covalently linked to a lipid moiety are disclosed. The oligonucleotide moiety comprises a sequence that is complementary to the RNA component of human telomerase. The compounds inhibit telomerase activity in cells with a high potency and have superior cellular uptake characteristics.
Patent expiration dates:
- December 27, 2025✓✓
- December 27, 2025
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Use of telomerase inhibitors for the treatment of myeloproliferative disorders and myeloproliferative neoplasms
Patent 9,375,485
Issued: June 28, 2016
Inventor(s): Stuart Monic J. & Kelsey Stephen
Assignee(s): Geron CorporationProvided herein are methods for reducing neoplastic progenitor cell proliferation and alleviating symptoms associated in individuals diagnosed with or thought to have Essential Thrombocythemia (ET). Also provided herein are methods for using telomerase inhibitors for maintaining blood platelet counts at relatively normal ranges in the blood of individuals diagnosed with or suspected of having ET.
Patent expiration dates:
- March 15, 2033✓
- March 15, 2033
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Modified oligonucleotides for telomerase inhibition
Patent 9,388,415
Issued: July 12, 2016
Inventor(s): Gryaznov; Sergei et al.Compounds comprising an oligonucleotide moiety covalently linked to a lipid moiety are disclosed. The oligonucleotide moiety comprises a sequence that is complementary to the RNA component of human telomerase. The compounds inhibit telomerase activity in cells with a high potency and have superior cellular uptake characteristics.
Patent expiration dates:
- September 9, 2025✓
- September 9, 2025
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Modified oligonucleotides for telomerase inhibition
Patent 9,388,416
Issued: July 12, 2016
Inventor(s): Gryaznov; Sergei et al.Compounds comprising an oligonucleotide moiety covalently linked to a lipid moiety are disclosed. The oligonucleotide moiety comprises a sequence that is complementary to the RNA component of human telomerase. The compounds inhibit telomerase activity in cells with a high potency and have superior cellular uptake characteristics.
Patent expiration dates:
- September 9, 2025✓
- September 9, 2025
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:
- June 6, 2031 - TREATMENT OF ADULT PATIENTS WITH LOW - TO INTERMEDIATE-1 RISK MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA REQUIRING 4 OR MORE RED BLOOD CELL UNITS OVER 8 WEEKS WHO HAVE NOT RESPONDED TO OR HAVE LOST RESPONSE TO OR ARE INELIGIBLE FOR
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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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
