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Last Updated: September 19, 2020

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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 one hundred and twenty-four patent family members in eighteen countries.

One supplier is listed for this compound.

Summary for golodirsen
International Patents:124
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 2
DailyMed Link:golodirsen at DailyMed
Recent Clinical Trials for golodirsen

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

SponsorPhase
Kevin FlaniganPhase 2
Sarepta Therapeutics, Inc.Phase 2
Sarepta TherapeuticsPhase 3

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
AstraZeneca
McKesson
Johnson and Johnson
Moodys

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