Question 1

Is there a generic for Dasiglucagon hydrochloride?

Accepted Answer

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

Question 2

What is the reference-listed drug for Dasiglucagon hydrochloride?

Accepted Answer

ZEGALOGUE (NDA 214231, ZEALAND PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Dasiglucagon hydrochloride?

Accepted Answer

The Orange Book lists 2 patents against Dasiglucagon hydrochloride products, with the earliest listed expiry in 2034. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Dasiglucagon hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Dasiglucagon hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Dasiglucagon hydrochloride are approved?

Accepted Answer

Dasiglucagon hydrochloride is approved in the following dosage form: solution.

Patent	Expires	In	Type
11795204	Jan 06, 2034	in 7 yr 8 mo	U-3752
10442847	Mar 22, 2035	in 8 yr 11 mo	SubstanceProduct

Dasiglucagon hydrochloride

Brand (NDA) products · solution

Marketing exclusivity (2)

Listed patents (2)

Dasiglucagon hydrochloride — frequently asked questions

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