Details for New Drug Application (NDA): 214518
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NDA 214518 describes TPOXX, which is a drug marketed by Siga Technologies and is included in two NDAs. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the TPOXX profile page.
The generic ingredient in TPOXX is tecovirimat. One supplier is listed for this compound. Additional details are available on the tecovirimat profile page.
The generic ingredient in TPOXX is tecovirimat. One supplier is listed for this compound. Additional details are available on the tecovirimat profile page.
Summary for 214518
| Tradename: | TPOXX |
| Applicant: | Siga Technologies |
| Ingredient: | tecovirimat |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214518
Generic Entry Date for 214518*:
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: 214518
Suppliers and Packaging for NDA: 214518
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TPOXX | tecovirimat | SOLUTION;INTRAVENOUS | 214518 | NDA | SIGA Technologies, Inc. | 50072-010 | 50072-010-01 | 7 VIAL in 1 CARTON (50072-010-01) / 20 mL in 1 VIAL (50072-010-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/20ML (10MG/ML) | ||||
| Approval Date: | May 18, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 2, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 4, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TPOXX IS INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 3 KG | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 23, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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