Question 1

Is there a generic for Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate?

Accepted Answer

MULTRYS (NDA 209376, AM REGENT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate?

Accepted Answer

The Orange Book lists 5 patents against Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate products, with the earliest listed expiry in 2041. 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

What dosage forms of Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate are approved?

Accepted Answer

Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate is approved in the following dosage form: solution.

Patent	Expires	In	Type
12150957	Jul 01, 2041	in 15 yr 3 mo	U-3900
12150956	Jul 01, 2041	in 15 yr 3 mo	U-3900
11975022	Jul 01, 2041	in 15 yr 3 mo	U-3900
11786548	Jul 01, 2041	in 15 yr 3 mo	Product
11998565	Jul 01, 2041	in 15 yr 3 mo	Product

Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate

Brand (NDA) products · solution

Listed patents (5)

Cupric sulfate; manganese sulfate; selenious acid; zinc sulfate — frequently asked questions

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