PHENYLEPHRINE HYDROCHLORIDE - Generic Drug Details

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

Phenylephrine hydrochloride is the generic ingredient in twelve branded drugs marketed by Alcon, Caplin, Mankind Pharma, Paragon Bioteck, Dr Reddys Labs Sa, Hikma, Accord Hlthcare, Amneal, Aspiro, Avet Lifesciences, Be Pharms, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Meitheal, Provepharm Sas, Sagent Pharms Inc, Sandoz, Exela Pharma, Ani Pharms, Genus, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, Xttrium Labs Inc, Allergan, and Eyenovia, and is included in thirty-eight NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Phenylephrine hydrochloride has one patent family member in one country.

There are twelve drug master file entries for phenylephrine hydrochloride. Thirty-seven suppliers are listed for this compound.

Summary for PHENYLEPHRINE HYDROCHLORIDE

International Patents:	1
US Patents:	6
Tradenames:	12
Applicants:	30
NDAs:	38
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	347
Patent Applications:	2,794
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHENYLEPHRINE HYDROCHLORIDE
What excipients (inactive ingredients) are in PHENYLEPHRINE HYDROCHLORIDE?	PHENYLEPHRINE HYDROCHLORIDE excipients list
DailyMed Link:	PHENYLEPHRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PHENYLEPHRINE HYDROCHLORIDE

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

Sponsor	Phase
University of Aarhus	Phase 2/Phase 3
Jason Chui	Phase 4
University of Miami	Phase 4

See all PHENYLEPHRINE HYDROCHLORIDE clinical trials

Pharmacology for PHENYLEPHRINE HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for PHENYLEPHRINE HYDROCHLORIDE

Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Nasal Decongestants
Sympathomimetics
Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for PHENYLEPHRINE HYDROCHLORIDE

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

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

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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
Dr Reddys Labs Sa	BIORPHEN	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	212909-002	Mar 11, 2021		DISCN	Yes	No	⤷ 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
Hainan Poly	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	218412-001	Mar 14, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	211920-002	Jun 5, 2020	AP1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	210333-002	Apr 27, 2018	AP1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	BIORPHEN	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	212909-001	Oct 21, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	203826-003	Jun 19, 2019		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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015073696		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PHENYLEPHRINE HYDROCHLORIDE

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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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