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^: ⤷ Sign Up* 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

Sponsor	Phase
Sarepta Therapeutics, Inc.	Phase 4
Rare Disease Research, LLC	Phase 4
Sarepta Therapeutics, Inc.	Phase 2

See all GOLODIRSEN clinical trials

Pharmacology for GOLODIRSEN

Drug Class	Antisense Oligonucleotide
Physiological Effect	Increased Protein Synthesis

Anatomical Therapeutic Chemical (ATC) Classes for GOLODIRSEN

M09AX	Other drugs for disorders of the musculo-skeletal system
M09A	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M09	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M	Musculo-skeletal system

US Patents and Regulatory Information for GOLODIRSEN

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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
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			⤷ 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	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

Expired US Patents for GOLODIRSEN

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

International Patents for GOLODIRSEN

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3808845	OLIGONUCLÉOTIDES ANTISENS POUR INDUIRE L'OMISSION DE L'EXON ET LEURS PROCÉDÉS D'UTILISATION (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF)	⤷ Sign Up
Cyprus	1111447		⤷ Sign Up
Cyprus	1117475		⤷ Sign Up
European Patent Office	2305200	Parure de transfert d'occupant (Occupant transfer topper)	⤷ Sign Up
Denmark	2206781		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.