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MYDCOMBI Drug Patent Profile

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When do Mydcombi patents expire, and what generic alternatives are available?

Mydcombi is a drug marketed by Eyenovia and is included in one NDA. There are three patents protecting this drug.

This drug has forty-four patent family members in fourteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Mydcombi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 5, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MYDCOMBI

International Patents:	44
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in MYDCOMBI?	MYDCOMBI excipients list
DailyMed Link:	MYDCOMBI at DailyMed

Drug patent expirations by year for MYDCOMBI

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

Generic Entry Date for MYDCOMBI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW PRODUCT NDA: 215352 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.

Pharmacology for MYDCOMBI

Drug Class	Anticholinergic alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists Cholinergic Antagonists

US Patents and Regulatory Information for MYDCOMBI

MYDCOMBI is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MYDCOMBI is ⤷ Sign Up.

This potential generic entry date is based on NEW PRODUCT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MYDCOMBI

Ophthalmic drug delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF ADMINISTERING AN EFFECTIVE DOSE OF TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE TO AN EYE

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF ADMINISTERING AN EFFECTIVE DOSE OF TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE TO AN EYE

FDA Regulatory Exclusivity protecting MYDCOMBI

NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for MYDCOMBI

See the table below for patents covering MYDCOMBI around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	6039719		⤷ Sign Up
Japan	5964826		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012009702		⤷ Sign Up
Canada	2805425	ADMINISTRATION DE MEDICAMENT OPHTALMIQUE (OPHTHALMIC DRUG DELIVERY)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MYDCOMBI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	15C0090	France	⤷ Sign Up	PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	2015/071	Ireland	⤷ Sign Up	PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	92923	Luxembourg	⤷ Sign Up	PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description