Details for New Drug Application (NDA): 214460
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NDA 214460 describes TEMBEXA, which is a drug marketed by Emergent Biodefense and is included in two NDAs. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the TEMBEXA profile page.
The generic ingredient in TEMBEXA is brincidofovir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the brincidofovir profile page.
The generic ingredient in TEMBEXA is brincidofovir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the brincidofovir profile page.
Summary for 214460
| Tradename: | TEMBEXA |
| Applicant: | Emergent Biodefense |
| Ingredient: | brincidofovir |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214460
Generic Entry Date for 214460*:
Constraining patent/regulatory exclusivity:
TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULT AND PEDIATRIC PATIENTS, INCLUDING NEONATES Dosage:
SUSPENSION;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.
Suppliers and Packaging for NDA: 214460
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TEMBEXA | brincidofovir | SUSPENSION;ORAL | 214460 | NDA | Emergent BioDefense Operations Lansing LLC | 64678-012 | 64678-012-01 | 65 mL in 1 BOTTLE (64678-012-01) |
| TEMBEXA | brincidofovir | SUSPENSION;ORAL | 214460 | NDA | Emergent BioDefense Operations Lansing LLC | 64678-012 | 64678-012-02 | 65 mL in 1 BOTTLE (64678-012-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Jun 4, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 4, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULT AND PEDIATRIC PATIENTS, INCLUDING NEONATES | ||||||||
| Patent: | 9,303,051 | Patent Expiration: | Jul 30, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING HUMAN SMALLPOX DISEASE | ||||||||
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