Details for New Drug Application (NDA): 211172
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NDA 211172 describes TEGSEDI, which is a drug marketed by Akcea Theraps and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the TEGSEDI profile page.
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.
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: | 6 |
DrugPatentWatch® Estimated Generic Entry Opportunity 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: | RX | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Oct 5, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Mar 21, 2023 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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