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

Drug patent expirations by year for RYTELO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RYTELO

Generic Entry Date for RYTELO^: ⤷ Sign Up* 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: 217779 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

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

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Glossary

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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

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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.

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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