Rytelo is a drug owned by Geron Corp. It is protected by 4 US drug patents filed in 2024. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 15, 2033. Details of Rytelo's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7494982 | Modified oligonucleotides for telomerase inhibition |
Dec, 2025
(1 year, 1 month from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9375485 | Use of telomerase inhibitors for the treatment of myeloproliferative disorders and myeloproliferative neoplasms |
Mar, 2033
(8 years from now) | Active |
| US9388415 | Modified oligonucleotides for telomerase inhibition |
Sep, 2024
(2 months ago) |
Expired
|
| US9388416 | Modified oligonucleotides for telomerase inhibition |
Sep, 2024
(2 months ago) |
Expired
|
FDA has granted several exclusivities to Rytelo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rytelo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rytelo.
Exclusivity Information
Rytelo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Rytelo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE-482) | Jun 06, 2031 |
US patents provide insights into the exclusivity only within the United States, but Rytelo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rytelo's family patents as well as insights into ongoing legal events on those patents.
Rytelo's Family Patents
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Generic Launch
Generic Release Date:
Rytelo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 15, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rytelo Generics:
There are no approved generic versions for Rytelo as of now.
About Rytelo
Rytelo is a drug owned by Geron Corp. Rytelo uses Imetelstat Sodium as an active ingredient. Rytelo was launched by Geron in 2024.
Approval Date:
Rytelo was approved by FDA for market use on 06 June, 2024.
Active Ingredient:
Rytelo uses Imetelstat Sodium as the active ingredient. Check out other Drugs and Companies using Imetelstat Sodium ingredient
Dosage:
Rytelo is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 47MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |
| EQ 188MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |