RYTELO Drug Patent Profile
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Which patents cover Rytelo, and when can generic versions of Rytelo launch?
Rytelo is a drug marketed by Geron and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and twenty-six patent family members in thirty-three countries.
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.
DrugPatentWatch® Generic Entry Outlook for Rytelo
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 6, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for RYTELO
International Patents: | 126 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
What excipients (inactive ingredients) are in RYTELO? | RYTELO excipients list |
DailyMed Link: | RYTELO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RYTELO
Generic Entry Date for RYTELO*:
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) NDA:
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.
US Patents and Regulatory Information for RYTELO
RYTELO is protected by four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of RYTELO is ⤷ Sign Up.
This potential generic entry date is based on 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).
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting RYTELO
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Use of telomerase inhibitors for the treatment of myeloproliferative disorders and myeloproliferative neoplasms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA
Modified oligonucleotides for telomerase inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA
Modified oligonucleotides for telomerase inhibition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS) WITH TRANSFUSION-DEPENDENT ANEMIA
FDA Regulatory Exclusivity protecting RYTELO
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)
Exclusivity Expiration: ⤷ Sign Up
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 | 217779-001 | 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 | Y | Y | ⤷ 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 | ||||
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 | ||||
>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 RYTELO
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 | 217779-002 | 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 RYTELO
See the table below for patents covering RYTELO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2012085648 | MODIFIED OLIGONUCLEOTIDE FOR TELOMERASE INHIBITION | ⤷ Sign Up |
European Patent Office | 3456333 | UTILISATION DE L'INHIBITEUR DE LA TÉLOMÉRASE IMETELSTAT POUR LE TRAITEMENT DU SYNDROME MYÉLODYSPLASIQUE (USE OF THE TELOMERASE INHIBITOR IMETELSTAT FOR THE TREATMENT OF MYELODYSPLASTIC SYNDROME) | ⤷ Sign Up |
Spain | 2789176 | ⤷ Sign Up | |
European Patent Office | 3342425 | OLIGONUCLÉOTIDES MODIFIÉS POUR L'INHIBITION DE LA TÉLOMÉRASE (MODIFIED OLIGONUCLEOTIDES FOR TELOMERASE INHIBITION) | ⤷ Sign Up |
Denmark | 2928477 | ⤷ Sign Up | |
Japan | 2021169466 | テロメラーゼ阻害のための改変オリゴヌクレオチド (MODIFIED OLIGONUCLEOTIDES FOR TELOMERASE INHIBITION) | ⤷ Sign Up |
China | 111617252 | 端粒酶抑制剂用于治疗骨髓增生性病症和骨髓增生性肿瘤的用途 (USE OF TELOMERASE INHIBITORS FOR THE TREATMENT OF MYELOPROLIFERATIVE DISORDERS AND MYELOPROLIFERATIVE NEOPLASMS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |