Is there a generic for Praziquantel?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Praziquantel, referencing the brand BILTRICIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Praziquantel?

BILTRICIDE (NDA 018714, BAYER HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Praziquantel are approved?

Praziquantel is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Praziquantel

Praziquantel is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BILTRICIDE · NDA 018714

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
BILTRICIDERLD	BAYER HLTHCARE	NDA 018714	—	Dec 29, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
PRAZIQUANTEL	PH HEALTH	ANDA 208820	—	Nov 27, 2017

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Praziquantel — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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