Details for New Drug Application (NDA): 206488
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NDA 206488 describes EXONDYS 51, 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 EXONDYS 51 profile page.
The generic ingredient in EXONDYS 51 is eteplirsen. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the eteplirsen profile page.
The generic ingredient in EXONDYS 51 is eteplirsen. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the eteplirsen profile page.
Summary for 206488
| Tradename: | EXONDYS 51 |
| Applicant: | Sarepta Theraps Inc |
| Ingredient: | eteplirsen |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206488
Generic Entry Date for 206488*:
Constraining patent/regulatory exclusivity:
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: 206488
Suppliers and Packaging for NDA: 206488
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488 | NDA | Sarepta Therapeutics, Inc. | 60923-284 | 60923-284-10 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-284-10) / 10 mL in 1 VIAL, SINGLE-USE |
| EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488 | NDA | Sarepta Therapeutics, Inc. | 60923-363 | 60923-363-02 | 1 VIAL, SINGLE-USE in 1 CARTON (60923-363-02) / 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: | Sep 19, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 10,337,003 | Patent Expiration: | Mar 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING | ||||||||
| Patent: | 10,364,431 | Patent Expiration: | Mar 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | RESTORING AN MRNA READING FRAME TO INDUCE DYSTROPHIN PROTEIN PRODUCTION IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING | ||||||||
| Patent: | 10,364,431 | Patent Expiration: | Mar 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING | ||||||||
Expired US Patents for NDA 206488
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | 10,533,174 | ⤷ Start Trial |
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | 10,533,174 | ⤷ Start Trial |
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | 10,781,451 | ⤷ Start Trial |
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | 9,416,361 | ⤷ Start Trial |
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | 9,018,368 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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