Details for New Drug Application (NDA): 215352

NDA 215352 describes MYDCOMBI, which is a drug marketed by Eyenovia and is included in one NDA. There are three patents protecting this drug. Additional details are available on the MYDCOMBI profile page.

The generic ingredient in MYDCOMBI is phenylephrine hydrochloride; tropicamide. There are twenty-one drug master file entries for this compound. Additional details are available on the phenylephrine hydrochloride; tropicamide profile page.

Summary for 215352

Tradename:	MYDCOMBI
Applicant:	Eyenovia
Ingredient:	phenylephrine hydrochloride; tropicamide
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 215352

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SPRAY, METERED;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;OPHTHALMIC			Strength	2.5%;1%
Approval Date:	May 5, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 5, 2026
Regulatory Exclusivity Use:	NEW PRODUCT
Patent:		Patent Expiration:	Jul 15, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF ADMINISTERING AN EFFECTIVE DOSE OF TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE TO AN EYE
Patent:		Patent Expiration:	Jul 15, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF ADMINISTERING AN EFFECTIVE DOSE OF TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE TO AN EYE

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