PHENYLEPHRINE HYDROCHLORIDE - Generic Drug Details

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-six 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:	36
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	347
Patent Applications:	2,923
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	213237-001	Jul 1, 2020		DISCN	No	No
G And W Labs Inc	PROMETH VC PLAIN	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088761-001	Nov 8, 1984		DISCN	Yes	No
Exela Pharma	VAZCULEP	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	204300-002	Jun 27, 2014	AP1	RX	Yes	Yes
Hikma	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040675-001	Dec 23, 2014		DISCN	No	No
Hikma	IMMPHENTIV	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	203826-005	Mar 9, 2023		RX	Yes	Yes	11,471,400		Y
Caplin	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	215183-002	May 23, 2024	AT	RX	No	No
Aspiro	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	218110-001	May 10, 2024	AP1	RX	No	No

International Patents for PHENYLEPHRINE HYDROCHLORIDE

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

PHENYLEPHRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Phenylephrine Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

Phenylephrine hydrochloride is a widely used active pharmaceutical ingredient (API) in the pharmaceutical industry, particularly for its decongestant and vasoconstrictor properties. Here is a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The phenylephrine hydrochloride market has been experiencing significant growth. As of 2023, the market size was valued at USD 0.9 billion and is expected to reach USD 1.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.8% from 2024 to 2031[1].

Another report indicates that the phenylephrine hydrochloride market size was valued at USD 777.6 million in 2022 and is anticipated to reach USD 1.6 billion by 2032, with a growth rate of 7.7% during the forecast period[4].

Key Drivers of Market Growth

Increasing Prevalence of Respiratory Ailments

The rising incidence of respiratory conditions such as allergies, sinusitis, and the common cold is a major driver of the phenylephrine hydrochloride market. These conditions necessitate the use of decongestant medications, which often contain phenylephrine hydrochloride[1][3][4].

Technological Advancements in Formulations

The adaptability of phenylephrine hydrochloride in various formulations, including nasal sprays, oral tablets, and ophthalmic solutions, contributes to its market growth. Technological advancements in pharmaceutical formulations have made it possible to develop more effective and convenient dosage forms[1][4].

Growing Pharmaceutical Industry

The expansion of the global pharmaceutical industry also plays a crucial role in the growth of the phenylephrine hydrochloride market. Increasing public awareness of effective remedies for cold and allergy symptoms further boosts demand[1][3].

Market Segmentation

Application Segments

The phenylephrine hydrochloride market is segmented based on applications such as nasal congestion, eye conditions, anesthesia, and cold & flu relief. The nasal congestion segment is particularly significant due to the high demand for decongestant medications[1].

Product Segments

The market is also segmented by product type, including oral tablets, injectable solutions, nasal sprays, and ophthalmic solutions. The oral segment dominates the market, with a significant market share[1][3].

Geographical Segments

Geographically, the market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America holds a substantial market share, with the U.S. expected to exhibit a CAGR of 6.9% between 2024 and 2032[1][3].

Challenges and Pitfalls

Price Volatility and Shortages

The market faces challenges such as price volatility and shortages, particularly in the ophthalmic segment. Financial instability at generic companies and narrow profit margins can lead to abrupt cessation of operations, resulting in supply-demand mismatches and price increases[2].

Regulatory Factors

Regulatory actions, such as those by the FDA, can significantly impact the market. For instance, the FDA's approval of specific formulations can lead to market exclusivity, reducing competition and driving up prices[2].

Profit Margins

Generic drug manufacturers face low profit margins, averaging around 5%, compared to the higher margins of brand-name drug manufacturers. This can lead to reduced competition and increased prices as smaller companies exit the market[2].

Competitive Landscape

The competitive landscape of the phenylephrine hydrochloride market is characterized by the presence of established pharmaceutical companies. These companies engage in strategic initiatives such as collaborations, product launches, investments, and partnerships to strengthen their product portfolios and address the rising demand for phenylephrine-based drugs[1][3].

Distribution Channels

The market is segmented by distribution channels, including hospital pharmacies, drug stores & retail pharmacies, and online pharmacies. Drug stores & retail pharmacies are expected to exhibit a significant CAGR during the forecast period[3].

Clinical and Economic Impact

The availability and pricing of phenylephrine hydrochloride have clinical consequences, particularly in ophthalmic practices. The lack of easy and inexpensive access to phenylephrine can affect cataract surgeries and other ophthalmic procedures, highlighting the need for stable and affordable supply chains[2].

"The thing that is disheartening for us is that we have been using this drug for years," Dr. Tsai said. "Every institution that I have talked to has stated they are not likely to use very much of the new, costly medication."[2]

Key Takeaways

• The phenylephrine hydrochloride market is expected to grow significantly, driven by the increasing prevalence of respiratory ailments and advancements in pharmaceutical formulations.
• The market is segmented by application, product type, and geographical regions, with North America holding a substantial market share.
• Challenges such as price volatility, shortages, and regulatory factors impact the market dynamics.
• Established pharmaceutical companies dominate the competitive landscape, engaging in various strategic initiatives.
• The market faces clinical and economic impacts due to the critical role of phenylephrine hydrochloride in various medical treatments.

FAQs

What is the current market size of the phenylephrine hydrochloride market?

The phenylephrine hydrochloride market size was valued at USD 0.9 billion in 2023 and USD 777.6 million in 2022, depending on the source[1][4].

What is the expected growth rate of the phenylephrine hydrochloride market?

The market is expected to grow at a CAGR of 5.8% from 2024 to 2031 and 7.7% from 2023 to 2032, according to different reports[1][4].

What are the main drivers of the phenylephrine hydrochloride market growth?

The main drivers include the increasing prevalence of respiratory ailments, technological advancements in formulations, and the expansion of the global pharmaceutical industry[1][3][4].

Which region holds the largest market share in the phenylephrine hydrochloride market?

North America holds a substantial market share, with the U.S. expected to exhibit a significant CAGR during the forecast period[1][3].

What are the challenges faced by the phenylephrine hydrochloride market?

Challenges include price volatility, shortages, regulatory factors, and low profit margins for generic manufacturers[2].

How does the competitive landscape of the phenylephrine hydrochloride market look?

The market is dominated by established pharmaceutical companies that engage in strategic initiatives such as collaborations, product launches, and partnerships[1][3].