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BILTRICIDE

NDA

PRAZIQUANTEL | N018714 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Novitium Pharma LLC FDA-2025-P-2524 Novitium Pharma LLC filed this relisting petition under sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. sections 314.122 and 314.161 requesting that the FDA determine whether Biltricide (praziquantel) oral tablet 600 mg, NDA 018714, owned by Bayer Healthcare Phar	505(q)	2025-07-21	Denied	Novitium Pharma LLC
Amendments to Suitability Petition from Noble Pharma LLC FDA-2018-P-2344 Noble Pharma, LLC filed this amendment to a suitability petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an Abbreviated New Animal Drug Application (ANADA) for a generic soft chewable scored tablet formulation of praziquantel 34 mg for dogs	Suitability	2018-08-16	Open	Noble Pharma LLC
Suitability Petition from Noble Pharma LLC FDA-2018-P-2344 Noble Pharma, LLC submitted a suitability petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated New Animal Drug Application (ANADA) for a generic soft chewable scored tablet formulation of praziquantel for dogs, which differs in dos	Suitability	2018-06-18	Open	Noble Pharma LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs2 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

MERCK KGAAPRAZIQUANTEL 2-(CYCLOHEXYLCARBONYL)-1,2,3,6,7,11BETA-4HPYRAZINO-(2,1-ALPHA)

DMF 42871981

PCASPRAZIQUANTEL

DMF 139991999

CIPLA LTDPRAZIQUANTEL USP

DMF 143521999

SOLARA ACTIVE PHARMA SCIENCES LTDPRAZIQUANTEL

DMF 260762012

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDPRAZIQUANTEL

DMF 268372013

HISUN PHARMACEUTICAL NANTONG CO LTDPRAZIQUANTEL USP

DMF 292712015

CHROMO LABORATORIES INDIA PRIVATE LTDPRAZIQUANTEL USP

DMF 353062021

MICRO LABS LTDPRAZIQUANTEL USP

DMF 374592022

AUTHENTERRA HEALTHCARE LLPPRAZIQUANTEL IP/BP/EP/USP

DMF 426962025

SHANGHAI NUMBER 6 PHARMACEUTICAL FACTORYInactivePRAZIQUANTEL

DMF 116311995

SEQUENT SCIENTIFIC LTDInactivePRAZIQUANTEL

DMF 238872010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 20, 2023	SUPPL -20	View Letter (PDF)
Jan 23, 2019	SUPPL -18	View Letter (PDF)
Feb 27, 2014	SUPPL -13	View Letter (PDF)
Aug 20, 2010	SUPPL -12	View Letter (PDF)
Jul 21, 2004	SUPPL -9	View Letter (PDF)
Jul 21, 2004	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 29, 1982

No patent or exclusivity listings for this strength.