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 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 208627

Tradename:	TPOXX
Applicant:	Siga Technologies
Ingredient:	tecovirimat
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208627

Generic Entry Date for 208627^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,339,466 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.

Pharmacology for NDA: 208627

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: 208627

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TPOXX	tecovirimat	CAPSULE;ORAL	208627	NDA	SIGA Technologies, Inc.	50072-200	50072-200-42	42 CAPSULE in 1 BOTTLE (50072-200-42)

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:	7,737,168	Patent Expiration:	Sep 4, 2031	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

Expired US Patents for NDA 208627

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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	⤷ Subscribe
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018	8,802,714	⤷ Subscribe
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018	8,530,509	⤷ Subscribe
>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.