Details for New Drug Application (NDA): 211172
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The generic ingredient in TEGSEDI is inotersen sodium. One supplier is listed for this compound. Additional details are available on the inotersen sodium profile page.
Summary for 211172
Tradename: | TEGSEDI |
Applicant: | Akcea Theraps |
Ingredient: | inotersen sodium |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211172
Generic Entry Date for 211172*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 211172
Physiological Effect | Decreased RNA Integrity Increased Protein Breakdown |
Suppliers and Packaging for NDA: 211172
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172 | NDA | Akcea Therapeutics, Inc. | 72126-007 | 72126-007-01 | 4 TRAY in 1 CARTON (72126-007-01) / 1 SYRINGE in 1 TRAY (72126-007-02) / 1.5 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) | ||||
Approval Date: | Oct 5, 2018 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 5, 2025 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS | ||||||||
Patent: | 8,101,743 | Patent Expiration: | Apr 1, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | 8,697,860 | Patent Expiration: | Apr 29, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 211172
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | 7,015,315 | ⤷ Subscribe |
Akcea Theraps | TEGSEDI | inotersen sodium | SOLUTION;SUBCUTANEOUS | 211172-001 | Oct 5, 2018 | 7,101,993 | ⤷ Subscribe |
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