Is there a generic for Glucagon hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Glucagon hydrochloride. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Glucagon hydrochloride?

GLUCAGON (NDA 201849, FRESENIUS KABI USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Glucagon hydrochloride are approved?

Glucagon hydrochloride is approved in the following dosage forms: injectable, powder.

FDA Orange Book · active-ingredient family

Glucagon hydrochloride

Glucagon hydrochloride is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:GLUCAGON · NDA 201849

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, powder

Product	Applicant	Application	TE	Approved
GLUCAGONRLD×2	FRESENIUS KABI USA	NDA 201849	—	May 08, 2015
GLUCAGENRLD×2	NOVO NORDISK	NDA 020918	—	Jun 22, 1998
GLUCAGONRLD×2	LILLY	NDA 012122	—	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.

Glucagon hydrochloride — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo