Details for New Drug Application (NDA): 217779
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NDA 217779 describes RYTELO, which is a drug marketed by Geron and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the RYTELO profile page.
The generic ingredient in RYTELO is imetelstat sodium. One supplier is listed for this compound. Additional details are available on the imetelstat sodium profile page.
The generic ingredient in RYTELO is imetelstat sodium. One supplier is listed for this compound. Additional details are available on the imetelstat sodium profile page.
Summary for 217779
| Tradename: | RYTELO |
| Applicant: | Geron |
| Ingredient: | imetelstat sodium |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217779
Generic Entry Date for 217779*:
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.
Suppliers and Packaging for NDA: 217779
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779 | NDA | Geron Corporation | 82959-111 | 82959-111-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (82959-111-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779 | NDA | Geron Corporation | 82959-112 | 82959-112-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (82959-112-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 47MG BASE/VIAL | ||||
| Approval Date: | Jun 6, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 6, 2031 | ||||||||
| Regulatory Exclusivity Use: | 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) | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 27, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA | ||||||||
Expired US Patents for NDA 217779
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Geron | RYTELO | imetelstat sodium | POWDER;INTRAVENOUS | 217779-001 | 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 | 217779-002 | Jun 6, 2024 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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