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.

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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 10,576,165 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

Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inducers

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:	10,576,165	Patent Expiration:	Aug 2, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	7,737,168	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:	8,039,504	Patent Expiration:	Jul 23, 2027	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 214518

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022	8,124,643	⤷ Subscribe
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022	8,802,714	⤷ Subscribe
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022	8,530,509	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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