Details for New Drug Application (NDA): 213026
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NDA 213026 describes AMONDYS 45, which is a drug marketed by Sarepta Theraps Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the AMONDYS 45 profile page.
The generic ingredient in AMONDYS 45 is casimersen. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the casimersen profile page.
The generic ingredient in AMONDYS 45 is casimersen. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the casimersen profile page.
Summary for 213026
| Tradename: | AMONDYS 45 |
| Applicant: | Sarepta Theraps Inc |
| Ingredient: | casimersen |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213026
Generic Entry Date for 213026*:
Constraining patent/regulatory exclusivity:
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 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: 213026
| Physiological Effect | Increased Protein Synthesis |
Suppliers and Packaging for NDA: 213026
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMONDYS 45 | casimersen | SOLUTION;INTRAVENOUS | 213026 | NDA | Sarepta Therapeutics, Inc. | 60923-227 | 60923-227-02 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-227-02) / 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: | Feb 25, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 25, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Feb 25, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING | ||||||||
| Patent: | 10,287,586 | Patent Expiration: | Nov 12, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 213026
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sarepta Theraps Inc | AMONDYS 45 | casimersen | SOLUTION;INTRAVENOUS | 213026-001 | Feb 25, 2021 | 10,533,174 | ⤷ Start Trial |
| Sarepta Theraps Inc | AMONDYS 45 | casimersen | SOLUTION;INTRAVENOUS | 213026-001 | Feb 25, 2021 | 9,416,361 | ⤷ Start Trial |
| Sarepta Theraps Inc | AMONDYS 45 | casimersen | SOLUTION;INTRAVENOUS | 213026-001 | Feb 25, 2021 | 9,447,415 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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