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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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:	⤷ Sign Up	Patent Expiration:	Aug 2, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	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:	⤷ Sign Up	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	⤷ Sign Up	⤷ Sign Up
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022	⤷ Sign Up	⤷ Sign Up
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.