Details for New Drug Application (NDA): 208627
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NDA 208627 describes TPOXX, which is a drug marketed by Siga Technologies and is included in two NDAs. It is available from one supplier. There are eight 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 208627
| Tradename: | TPOXX |
| Applicant: | Siga Technologies |
| Ingredient: | tecovirimat |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208627
Generic Entry Date for 208627*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Jul 13, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 13, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG | ||||||||
| Patent: | 11,890,270 | Patent Expiration: | Aug 8, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG | ||||||||
| Patent: | 12,433,868 | Patent Expiration: | Mar 23, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 208627
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Siga Technologies | TPOXX | tecovirimat | CAPSULE;ORAL | 208627-001 | Jul 13, 2018 | 8,124,643 | ⤷ Get Started Free |
| Siga Technologies | TPOXX | tecovirimat | CAPSULE;ORAL | 208627-001 | Jul 13, 2018 | 8,802,714 | ⤷ Get Started Free |
| Siga Technologies | TPOXX | tecovirimat | CAPSULE;ORAL | 208627-001 | Jul 13, 2018 | 8,530,509 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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