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Last Updated: March 26, 2023

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 twenty-nine patent family members in thirteen countries.

One supplier is listed for this compound.

Summary for golodirsen
International Patents:29
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
Recent Clinical Trials for golodirsen

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

SponsorPhase
Rare Disease Research, LLCPhase 4
Sarepta Therapeutics, Inc.Phase 4
Sarepta Therapeutics, Inc.Phase 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 golodirsen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc VYONDYS 53 golodirsen SOLUTION;INTRAVENOUS 211970-001 Dec 12, 2019 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for golodirsen

Country Patent Number Title Estimated Expiration
European Patent Office 3228711 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) See Plans and Pricing
Poland 2206781 See Plans and Pricing
Slovenia 2206781 See Plans and Pricing
Portugal 1766010 See Plans and Pricing
Austria 498685 See Plans and Pricing
Hong Kong 1216545 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) See Plans and Pricing
Croatia P20110352 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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