Question 1

Is there a generic for Ketorolac tromethamine; phenylephrine hydrochloride?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ketorolac tromethamine; phenylephrine hydrochloride, referencing the brand OMIDRIA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Ketorolac tromethamine; phenylephrine hydrochloride?

Accepted Answer

OMIDRIA (NDA 205388, RAYNER SURGICAL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Ketorolac tromethamine; phenylephrine hydrochloride?

Accepted Answer

The Orange Book lists 5 patents against Ketorolac tromethamine; phenylephrine hydrochloride products, with the earliest listed expiry in 2033. 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 Ketorolac tromethamine; phenylephrine hydrochloride are approved?

Accepted Answer

Ketorolac tromethamine; phenylephrine hydrochloride is approved in the following dosage form: solution.

Patent	Expires	In	Type
9486406	Oct 23, 2033	in 7 yr 5 mo	Product
9066856	Oct 23, 2033	in 7 yr 5 mo	Product
9855246	Oct 23, 2033	in 7 yr 5 mo	Product
9066856*PED	Apr 23, 2034	in 8 yr
9486406*PED	Apr 23, 2034	in 8 yr

Ketorolac tromethamine; phenylephrine hydrochloride

Brand (NDA) products · solution

Generic (ANDA) products (1)

Listed patents (5)

Ketorolac tromethamine; phenylephrine hydrochloride — frequently asked questions

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