PHENYLEPHRINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Phenylephrine Hydrochloride, and when can generic versions of Phenylephrine Hydrochloride launch?

Phenylephrine Hydrochloride is a drug marketed by Alcon, Mankind Pharma, Paragon Bioteck, Accord Hlthcare, Amneal, Avet Lifesciences, Be Pharms, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Par Sterile Products, Provepharm Sas, Sagent Pharms Inc, Sandoz, and Pharm Assoc. and is included in twenty-five NDAs. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phenylephrine Hydrochloride

A generic version of PHENYLEPHRINE HYDROCHLORIDE was approved as phenylephrine hydrochloride; promethazine hydrochloride by PHARM ASSOC on December 7^th, 2006.

Summary for PHENYLEPHRINE HYDROCHLORIDE

International Patents:	1
US Patents:	1
Applicants:	18
NDAs:	25
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	336
Patent Applications:	1,869
Formulation / Manufacturing:	see details
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 Miami	Phase 4
Abant Izzet Baysal University	Phase 4
Ciusss de L'Est de l'Île de Montréal	N/A

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

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

PHENYLEPHRINE HYDROCHLORIDE is protected by one US patents and two FDA Regulatory Exclusivities.

Patents protecting PHENYLEPHRINE HYDROCHLORIDE

FDA Regulatory Exclusivity protecting PHENYLEPHRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Provepharm Sas	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	211081-001	Jul 17, 2020	AP1	RX	No	No
Mankind Pharma	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	217069-001	Aug 30, 2022	AP1	RX	No	No
Sandoz	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	208905-003	Jan 31, 2019	AP1	RX	No	No
Sagent Pharms Inc	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	209967-002	Jan 16, 2020	AP1	RX	No	No
Hikma	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040675-001	Dec 23, 2014	AA	RX	No	No
Gland Pharma Ltd	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	211920-002	Jun 5, 2020	AP1	RX	No	No
Mankind Pharma	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	217069-002	Aug 30, 2022	AP1	RX	No	No

International Patents for PHENYLEPHRINE HYDROCHLORIDE

See the table below for patents covering PHENYLEPHRINE HYDROCHLORIDE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015073696

Supplementary Protection Certificates for PHENYLEPHRINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	92923	Luxembourg		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
1534313	2015/071	Ireland		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	15C0090	France		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