Details for New Drug Application (NDA): 206488
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The generic ingredient in EXONDYS 51 is eteplirsen. 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: | 9 |
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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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 | 206488-001 | Sep 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-002 | Sep 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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