Is there a generic for Teriparatide acetate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Teriparatide acetate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Teriparatide acetate?

PARATHAR (NDA 019498, SANOFI AVENTIS US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Teriparatide acetate are approved?

Teriparatide acetate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Teriparatide acetate

Teriparatide acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PARATHAR · NDA 019498

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
PARATHAR	SANOFI AVENTIS US	NDA 019498	—	Dec 23, 1987

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.

Teriparatide acetate — frequently asked questions

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

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