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
Sponsor | Phase |
---|---|
Rare Disease Research, LLC | Phase 4 |
Sarepta Therapeutics, Inc. | Phase 4 |
Sarepta Therapeutics, Inc. | Phase 2 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GOLODIRSEN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
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) | ⤷ Try a Trial |
Austria | E498685 | ⤷ Try a Trial | |
European Patent Office | 3029142 | 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) | ⤷ Try a Trial |
European Patent Office | 2305200 | Parure de transfert d'occupant (Occupant transfer topper) | ⤷ Try a Trial |
Spain | 2361325 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |