PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE - Generic Drug Details

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What are the generic drug sources for phenylephrine hydrochloride; tropicamide and what is the scope of freedom to operate?

Phenylephrine hydrochloride; tropicamide is the generic ingredient in one branded drug marketed by Eyenovia and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Phenylephrine hydrochloride; tropicamide has forty-four patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

International Patents:	44
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	26
DailyMed Link:	PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

Generic Entry Date for PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE^: ⤷ Sign Up* 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.

Recent Clinical Trials for PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National and Kapodistrian University of Athens	Phase 4
Eyenovia Inc.	Phase 4
Ocuphire Pharma, Inc.	Phase 3

See all PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE clinical trials

Pharmacology for PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AX	Other agents for treatment of hemorrhoids and anal fissures for topical use
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

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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 PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

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Country	Patent Number	Title	Estimated Expiration
Canada	2805426	DISPOSITIF DE GENERATION DE GOUTTELETTES (DROP GENERATING DEVICE)	⤷ Sign Up
South Korea	20130051476	OPHTHALMIC DRUG DELIVERY	⤷ Sign Up
Japan	2015120035	点眼薬送達 (OPHTHALMIC DRUG DELIVERY)	⤷ Sign Up
South Korea	20130054352	DROP GENERATING DEVICE	⤷ Sign Up
European Patent Office	2593055	PROCÉDÉ ET SYSTÈME DE RÉALISATION D'UN TRAITEMENT ET D'UNE SURVEILLANCE À DISTANCE (METHOD AND SYSTEM FOR PERFORMING REMOTE TREATMENT AND MONITORING)	⤷ Sign Up
European Patent Office	2485691	ADMINISTRATION DE MÉDICAMENT OPHTALMIQUE (OPHTHALMIC DRUG DELIVERY)	⤷ Sign Up
China	103118643	Method and system for performing remote treatment and monitoring	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

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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

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