Tecovirimat - Generic Drug Details

What are the generic drug sources for tecovirimat and what is the scope of freedom to operate?

Tecovirimat is the generic ingredient in one branded drug marketed by Siga Technologies and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tecovirimat has ninety-five patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for tecovirimat

International Patents:	95
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	10
Patent Applications:	71
DailyMed Link:	tecovirimat at DailyMed

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

Dosage:

CAPSULE;ORAL

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.

Recent Clinical Trials for tecovirimat

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Calmy Alexandra	Phase 3
Oswaldo Cruz Foundation	Phase 3
ANRS, Emerging Infectious Diseases	Phase 3

See all tecovirimat clinical trials

Pharmacology for tecovirimat

Drug Class	Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inducers

Anatomical Therapeutic Chemical (ATC) Classes for tecovirimat

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for tecovirimat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes			Y
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes			Y
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes			Y
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes
Siga Technologies	TPOXX	tecovirimat	CAPSULE;ORAL	208627-001	Jul 13, 2018		RX	Yes	Yes			Y	Y
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518-001	May 18, 2022		RX	Yes	Yes

International Patents for tecovirimat

Country	Patent Number	Title	Estimated Expiration
Japan	5657489
China	103281898	St-246 liquid formulations and methods
South Korea	20130018271	POLYMORPHIC FORMS ST-246 AND METHODS OF PREPARATION
Israel	201736	תכשירים המכילים תולדות של אצילהידרזיד ציקלי ויחידות מינון הכוללות אותם (Compositions comprising cyclic acylhydrazide derivatives and a dosage unit comprising the same)
European Patent Office	3006425	COMPOSITION PHARMACEUTIQUE DESTINEES AU TRAITEMENT ET A LA PRÉVENTION D'UNE INFECTION CAUSÉE PAR DES ORTHOPOXVIRUS (PHARMACEUTICAL COMPOSITION FOR USE IN THE TREATMENT AND PREVENTION OF ORTHOPOXVIRUS INFECTIONS AND ASSOCIATED DISEASES)
Israel	242666	תהליך להכנת 4-trifluoromethyl-n-(3,3a,4,4a,5,5a,6,6a-octahydro-1,3-dioxo-4,6-ethenocycloprop[f] isoindol-2(lh)-yl)-benzamide (st-246) (Process for producing 4-trifluoromethyl-n-(3,3a,4,4a,5,5a,6,6a-octahydro-1,3-dioxo-4,6-ethenocycloprop[f] isoindol-2(lh)-yl)-benzamide (st-246))

Supplementary Protection Certificates for tecovirimat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638938	2290024-5	Sweden		PRODUCT NAME: TECOVIRIMAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1600/001 20220107
1638938	301177	Netherlands		PRODUCT NAME: TECOVIRIMAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1600/001 20220107
2549871	122022000033	Germany		PRODUCT NAME: TECOVIRIMAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1600 20220106
1638938	122022000032	Germany		PRODUCT NAME: TECOVIRIMAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1600 20220106
2549871	22C1023	France		PRODUCT NAME: TECOVIRIMAT, SOUS TOUTES LES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE; REGISTRATION NO/DATE: EU/1/21/1600/001 20220106
1638938	C202230021	Spain		PRODUCT NAME: TECOVIRIMAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1600; DATE OF AUTHORISATION: 20220106; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1600; DATE OF FIRST AUTHORISATION IN EEA: 20220106