Is there a generic for Protirelin?

The FDA Orange Book does not currently list an approved generic (ANDA) for Protirelin. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Protirelin?

THYPINONE (NDA 017638, ABBOTT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Protirelin are approved?

Protirelin is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Protirelin

Protirelin is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:THYPINONE · NDA 017638

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
THYPINONE	ABBOTT	NDA 017638	—	Approved Prior to Jan 1, 1982
THYREL TRH	FERRING	NDA 018087	—	Approved Prior to Jan 1, 1982

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.

Protirelin — frequently asked questions

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

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