TRICLABENDAZOLE - Generic Drug Details

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What are the generic drug sources for triclabendazole and what is the scope of patent protection?

Triclabendazole is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for triclabendazole. One supplier is listed for this compound.

Summary for TRICLABENDAZOLE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	2
Patent Applications:	2,637
What excipients (inactive ingredients) are in TRICLABENDAZOLE?	TRICLABENDAZOLE excipients list
DailyMed Link:	TRICLABENDAZOLE at DailyMed

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

Generic Entry Date for TRICLABENDAZOLE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: INDICATED FOR THE TREATMENT OF FASCIOLIASIS IN PATIENTS 6 YEARS OF AGE AND OLDER Dosage: TABLET;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.

Recent Clinical Trials for TRICLABENDAZOLE

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 4
University of Colorado, Denver

See all TRICLABENDAZOLE clinical trials

Pharmacology for TRICLABENDAZOLE

Drug Class	Anthelmintic
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2A6 Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TRICLABENDAZOLE

P02BX	Other antitrematodal agents
P02B	ANTITREMATODALS
P02	ANTHELMINTICS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for TRICLABENDAZOLE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EGATEN	triclabendazole	TABLET;ORAL	208711-001	Feb 13, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	EGATEN	triclabendazole	TABLET;ORAL	208711-001	Feb 13, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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