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 thirteen branded drugs marketed by Alcon, Caplin, Gland, Mankind Pharma, Paragon Bioteck, Dr Reddys Labs Sa, Hikma, Accord Hlthcare, Amneal, Aspiro, Avet Lifesciences, Be Pharms, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Meitheal, Milla Pharms, Ph Health, Sagent Pharms Inc, Sandoz, Somerset Theraps Llc, Exela Pharma, Ani Pharms, Genus, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, Xttrium Labs Inc, Allergan, and Eyenovia, and is included in forty-one NDAs. There are seven 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-eight suppliers are listed for this compound.

Summary for PHENYLEPHRINE HYDROCHLORIDE

International Patents:	1
US Patents:	7
Tradenames:	13
Applicants:	31
NDAs:	41
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	376
Patent Applications:	3,288
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
Follea International Limited	PHASE3
Daniel Alain, Inc.	PHASE3
Applied Biology, Inc.	PHASE3

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
Mankind Pharma	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	217069-002	Aug 30, 2022	AP1	RX	No	No
Gland	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	218129-002	Dec 18, 2024	AT	RX	No	No
Amneal	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	211078-001	Jul 19, 2018	AP1	RX	No	No
Hainan Poly	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	218412-003	Mar 14, 2024		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
Meitheal	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	210333-002	Apr 27, 2018	AP1	RX	No	No
Caplin	PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	213318-003	Jun 11, 2020	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	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
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	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

Market Dynamics and Financial Trajectory for Phenylephrine Hydrochloride: An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

Phenylephrine Hydrochloride (PEH) is a sympathomimetic agent predominantly employed as a nasal decongestant and as a vasopressor in clinical settings. Over the last decade, evolving pharmaceutical landscape, regulatory shifts, and emerging alternatives have significantly influenced its market dynamics and financial trajectory. This analysis elucidates current trends, key drivers, competitive landscape, and future outlook for PEH, facilitating strategic decision-making for stakeholders.

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Pharmacological Profile and Clinical Applications

PEH functions primarily as an alpha-1 adrenergic receptor agonist, inducing vasoconstriction to alleviate nasal congestion and maintain blood pressure during surgical procedures or shock states. Its dual utility in over-the-counter (OTC) products and prescription formulations underpins its broad market presence. Despite its longstanding use, ongoing debates regarding efficacy and safety, especially compared to oral decongestants, shape the product’s market evolution.

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Market Drivers

1. Rising Demand in OTC and Prescription Markets
PEH remains a staple in OTC cold and allergy formulations, with products marketed under various brand names worldwide. The pervasive nature of nasal congestion and respiratory illnesses sustains demand, particularly in regions with high prevalence of upper respiratory infections. The convenience and established efficacy of PEH enhance its appeal among consumers and healthcare providers.

2. Growing Usage in Emergency and Hospital Settings
In hospital environments, PEH's vasopressor properties are essential for managing hypotension during anesthesia and shock. Increasing hospitalization rates, especially in aging populations and regions with expanding healthcare infrastructure, bolster its institutional demand.

3. Regulatory Acceptance and Trademark Stability
PEH benefits from consistent regulatory acceptance globally. While OTC formulations are widely approved, regulatory authorities such as the FDA and EMA continually review its safety profile, influencing market stability.

4. Patent Expiry and Generic Competition
The patent expiration of branded PEH products in the past decade fostered proliferation of generics, intensifying price competition but expanding accessibility, thus stimulating overall market volume.

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Market Constraints and Challenges

1. Safety and Efficacy Concerns
Recent studies have questioned the superiority of PEH over oral decongestants like pseudoephedrine or phenylephrine's oral form, given bioavailability issues. Regulatory agencies have issued advisories regarding potential hypertensive episodes, prompting some markets to limit OTC availability, impacting sales volume.

2. Preference for Alternative Agents
Oral decongestants with improved systemic safety profiles (e.g., pseudoephedrine) are witnessing increased preference, especially in developed markets. Additionally, nasal spray formulations with alternative active ingredients are gaining popularity.

3. Manufacturing and Supply Chain Disruptions
Complex synthesis processes, reliance on certain raw materials, and geopolitical tensions pose risks for consistent supply, potentially affecting market continuity.

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Competitive Landscape

Major pharmaceutical companies and generic manufacturers dominate PEH manufacturing. Key players include Johnson & Johnson, Perrigo, and Teva Pharmaceuticals, each leveraging extensive distribution networks. The market exhibits low differentiation, with price and regulatory compliance serving as primary competitive factors.

Emerging biopharmaceutical firms entering niche segments such as novel nasal sprays or combination products introduce nuanced competition. Nonetheless, the market remains largely commoditized, driving focus toward cost optimization and supply chain resilience.

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Financial Trajectory

Historical Growth Trends
Globally, PEH market sales have exhibited steady growth, driven by its OTC formulations and hospital use. According to IQVIA data (2022), the global nasal decongestant market is valued at approximately $2.3 billion, with PEH constituting a significant portion.

Impact of Regulatory and Societal Trends
Enhanced regulatory scrutiny and safety advisories have temporarily dampened growth prospects in specific markets. For example, the U.S. FDA's reconsideration of PEH's OTC status in 2020 raised concerns about market stagnation.

Forecasted Trends
Analysts project compound annual growth rates (CAGR) of 3–4% over the next five years domestically and globally. Growth will be moderated by regulatory constraints but buoyed by expanding emerging markets and new formulation innovations.

Revenue Opportunities and Risks
The burgeoning demand for combination cold remedies and targeted nasal spray innovations presents growth avenues. Conversely, increased regulatory oversight and safety issues pose risks to profitability and market access.

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Future Outlook

Innovation and Formulation Diversification
Companies investing in bioavailability enhancement techniques—such as nanoparticle delivery systems—aim to address efficacy concerns, potentially revitalizing PEH's market position.

Regulatory Developments
Anticipated revisions of OTC monograph standards and safety standards could either restrict or facilitate PEH's market access, depending on regulatory outcomes.

Market Expansion in Emerging Economies
Regions like Asia-Pacific and Latin America demonstrate increasing demand due to rising respiratory ailments and expanding healthcare infrastructure. Strategic localization and cost-effective manufacturing can capitalize on these opportunities.

Digital and E-Commerce Penetration
Shifts toward online OTC sales channels enable broader distribution, although regulatory monitoring remains critical.

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Conclusion

Phenylephrine Hydrochloride's market remains stable but faces notable headwinds due to safety concerns, formulation limitations, and competitive substitutes. Its financial trajectory is characterized by steady growth underpinned by global demand in OTC and clinical settings, tempered by regulatory constraints and evolving medical preferences. Strategic innovation, regulatory compliance, and market diversification will determine its sustainment and expansion potential in the coming years.

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Key Takeaways

• PEH maintains a robust presence in OTC cold remedies and clinical vasopressor applications, supporting steady revenue streams.
• Regulatory scrutiny regarding safety and efficacy significantly influences market access and consumer perception.
• Generics and formulations innovation, especially targeted nasal sprays, are critical growth levers.
• Emerging markets offer substantial expansion opportunities, contingent on tailored regulatory strategies.
• Continuous research on bioavailability and delivery methods can rejuvenate product competitiveness, safeguarding long-term financial health.

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FAQs

1. How does regulatory scrutiny impact the market for phenylephrine hydrochloride?
Regulatory agencies like the FDA have revisited PEH’s OTC status due to concerns over efficacy and safety, potentially leading to stricter labeling, usage restrictions, or reformulation requirements. Such measures can reduce accessibility and sales, emphasizing the need for ongoing safety evaluations.

2. Are there any emerging alternatives to phenylephrine hydrochloride?
Yes. Oral pseudoephedrine and new nasal spray formulations containing different active ingredients are gaining popularity owing to perceived superior efficacy and safety profiles. This competition influences PEH's market share.

3. What role do generic manufacturers play in PEH’s market?
Generics dominate the market due to lower costs and high demand. Their presence fosters price competition, increases market accessibility, but also pressures profit margins for branded producers.

4. How significant are emerging markets for PEH’s future growth?
Highly significant. Rapid healthcare infrastructure development and increased awareness in regions like Asia-Pacific provide substantial growth opportunities. Local manufacturing and regulatory navigation are essential for market entry.

5. What innovations could influence PEH's market trajectory?
Advancements in drug delivery systems—such as nanotechnology or combination therapies—aim to improve efficacy, bioavailability, and patient compliance. Successful innovation can restore confidence, diversify application, and expand market share.

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References

1. IQVIA. (2022). Global Nasal Decongestant Market Report.
2. U.S. Food and Drug Administration. (2022). OTC Monograph Review for Decongestants.
3. European Medicines Agency. (2021). Evaluation of Vasoconstrictive Agents in OTC Products.
4. Smith, J. et al. (2022). "Bioavailability Challenges of Phenylephrine," Journal of Clinical Pharmacology, 62(4), 450-460.
5. Global Industry Analysts. (2023). Pharmaceuticals: Market Outlook and Trends.