Details for New Drug Application (NDA): 211970
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NDA 211970 describes VYONDYS 53, which is a drug marketed by Sarepta Theraps Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VYONDYS 53 profile page.
The generic ingredient in VYONDYS 53 is golodirsen. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the golodirsen profile page.
The generic ingredient in VYONDYS 53 is golodirsen. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the golodirsen profile page.
Summary for 211970
| Tradename: | VYONDYS 53 |
| Applicant: | Sarepta Theraps Inc |
| Ingredient: | golodirsen |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211970
Generic Entry Date for 211970*:
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.
Pharmacology for NDA: 211970
| Physiological Effect | Increased Protein Synthesis |
Suppliers and Packaging for NDA: 211970
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970 | NDA | Sarepta Therapeutics, Inc. | 60923-465 | 60923-465-02 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-465-02) / 2 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/2ML (50MG/ML) | ||||
| Approval Date: | Dec 12, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 12, 2026 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Patent: | RE47691 | Patent Expiration: | Jun 28, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 211970
| 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 | 10,227,590 | ⤷ Start Trial |
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | 9,416,361 | ⤷ Start Trial |
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | 9,994,851 | ⤷ Start Trial |
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | 9,024,007 | ⤷ Start Trial |
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | 10,533,174 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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