Question 1

Is there a generic for Phenylephrine hydrochloride; tropicamide?

Accepted Answer

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

Question 2

What is the reference-listed drug for Phenylephrine hydrochloride; tropicamide?

Accepted Answer

MYDCOMBI (NDA 215352, EYENOVIA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Phenylephrine hydrochloride; tropicamide?

Accepted Answer

The Orange Book lists 3 patents against Phenylephrine hydrochloride; tropicamide products, with the earliest listed expiry in 2031. 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 Phenylephrine hydrochloride; tropicamide have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Phenylephrine hydrochloride; tropicamide. 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 Phenylephrine hydrochloride; tropicamide are approved?

Accepted Answer

Phenylephrine hydrochloride; tropicamide is approved in the following dosage form: spray, metered.

Patent	Expires	In	Type
11398306	Jul 15, 2031	in 5 yr 2 mo	U-3685
10839960	Jul 15, 2031	in 5 yr 2 mo	U-3685
11839487	Jul 15, 2031	in 5 yr 2 mo	U-3685

Phenylephrine hydrochloride; tropicamide

Brand (NDA) products · spray, metered

Marketing exclusivity (1)

Listed patents (3)

Phenylephrine hydrochloride; tropicamide — frequently asked questions

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