IMETELSTAT SODIUM - Generic Drug Details
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What are the generic drug sources for imetelstat sodium and what is the scope of freedom to operate?
Imetelstat sodium
is the generic ingredient in one branded drug marketed by Geron and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Imetelstat sodium has one hundred and twenty-six patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for IMETELSTAT SODIUM
| International Patents: | 126 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 7 |
| Patent Applications: | 31 |
| What excipients (inactive ingredients) are in IMETELSTAT SODIUM? | IMETELSTAT SODIUM excipients list |
| DailyMed Link: | IMETELSTAT SODIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IMETELSTAT SODIUM
Generic Entry Date for IMETELSTAT SODIUM*:
Constraining patent/regulatory exclusivity:
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 ERYTHROPOIESIS-STIMULATING AGENTS (ESA) Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for IMETELSTAT SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Oncology Group | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
| Pediatric Brain Tumor Consortium | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for IMETELSTAT SODIUM
US Patents and Regulatory Information for IMETELSTAT SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Geron | RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779-002 | Jun 6, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Geron | RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779-001 | Jun 6, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Geron | RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779-002 | Jun 6, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Geron | RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779-001 | Jun 6, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for IMETELSTAT SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Geron | RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779-002 | Jun 6, 2024 | ⤷ Sign Up | ⤷ Sign Up |
| Geron | RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779-001 | Jun 6, 2024 | ⤷ Sign Up | ⤷ Sign Up |
| Geron | RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779-002 | Jun 6, 2024 | ⤷ Sign Up | ⤷ Sign Up |
| Geron | RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779-001 | Jun 6, 2024 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IMETELSTAT SODIUM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Serbia | 60401 | UPOTREBA INHIBITORA TELOMERAZE IMETELSTATA ZA LEČENJE MIJELODISPLASTIČNOG SINDROMA (USE OF THE TELOMERASE INHIBITOR IMETELSTAT FOR THE TREATMENT OF MYELODYSPLASTIC SYNDROME) | ⤷ Sign Up |
| Portugal | 3342425 | ⤷ Sign Up | |
| New Zealand | 708920 | Use of telomerase inhibitors for the treatment of myeloproliferative disorders and myeloproliferative neoplasms | ⤷ Sign Up |
| China | 104936602 | USE OF TELOMERASE INHIBITORS FOR THE TREATMENT OF MYELOPROLIFERATIVE DISORDERS AND MYELOPROLIFERATIVE NEOPLASMS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
