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Last Updated: May 22, 2024

Golodirsen - Generic Drug Details


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What are the generic drug sources for golodirsen and what is the scope of freedom to operate?

Golodirsen is the generic ingredient in one branded drug marketed by Sarepta Theraps Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Golodirsen has thirty patent family members in thirteen countries.

One supplier is listed for this compound.

Summary for golodirsen
International Patents:30
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 4
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for golodirsen
What excipients (inactive ingredients) are in golodirsen?golodirsen excipients list
DailyMed Link:golodirsen at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for golodirsen
Generic Entry Date for golodirsen*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING
Dosage:
SOLUTION;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 golodirsen

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rare Disease Research, LLCPhase 4
Sarepta Therapeutics, Inc.Phase 4
Kevin FlaniganPhase 2

See all golodirsen clinical trials

US Patents and Regulatory Information for golodirsen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 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

International Patents for golodirsen

Country Patent Number Title Estimated Expiration
Poland 2206781 ⤷  Sign Up
Cyprus 1117475 ⤷  Sign Up
European Patent Office 2933332 OLIGONUCLÉOTIDES ANTISENS PERMETTANT D'INDUIRE UN SAUT D'EXON ET LEURS PROCÉDÉS D'UTILISATION (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF) ⤷  Sign Up
European Patent Office 2305200 Parure de transfert d'occupant (Occupant transfer topper) ⤷  Sign Up
Hong Kong 1245325 用於誘導外顯子跳躍的反義寡核苷酸及其使用方法 (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2006000057 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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