PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for phenylephrine hydrochloride; promethazine hydrochloride and what is the scope of patent protection?

Phenylephrine hydrochloride; promethazine hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms, Genus, Hikma, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, and Xttrium Labs Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

US Patents:	0
Tradenames:	6
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
DailyMed Link:	PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

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

Sponsor	Phase
University of North Carolina, Chapel Hill	PHASE4

See all PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE clinical trials

Pharmacology for PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

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

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

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

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

R06AD	Phenothiazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
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; PROMETHAZINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xttrium Labs Inc	PROMETHAZINE VC PLAIN	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088897-001	Jan 4, 1985		DISCN	No	No
Ani Pharms	PHENERGAN VC	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	008604-003	Apr 2, 1984		DISCN	Yes	No
Halsey	PHERAZINE VC	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088868-001	Mar 2, 1987		DISCN	No	No
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040902-001	Aug 25, 2009	AA	RX	No	No
G And W Labs Inc	PROMETH VC PLAIN	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088761-001	Nov 8, 1984		DISCN	Yes	No
Genus	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040654-001	Dec 7, 2006	AA	RX	No	Yes

Market Dynamics and Financial Trajectory for Phenylephrine Hydrochloride and Promethazine Hydrochloride

Last updated: February 15, 2026

Overview

Phenylephrine hydrochloride and promethazine hydrochloride are active pharmaceutical ingredients (APIs) with established roles in emergency and chronic therapy. Phenylephrine is primarily used as a decongestant and vasopressor, while promethazine functions as an antihistamine and antiemetic. Both compounds are marketed globally, with formulations including injectables, tablets, and syrups.

Market Size and Growth Drivers

Phenylephrine Hydrochloride

• Global Market Value (2022): Estimated at $320 million.
• Compound Annual Growth Rate (CAGR): Expected at 4% from 2023 to 2028.
• Key Drivers: Rise in cold and allergy medications, increased use in emergency settings for shock management, and the shift toward oral decongestants over pseudoephedrine due to regulatory restrictions.

Promethazine Hydrochloride

• Global Market Value (2022): Approximate $150 million.
• CAGR: Projected at 3.5% through 2028.
• Key Drivers: Long-standing efficacy as an antiemetic, demand in hospital settings, and steroid-sparing effects in allergic conditions.

Regulatory and Commercial Factors

1. Regulatory Status:

   • Both drugs are marketed in multiple jurisdictions, with USFDA approval for various formulations.
   • Phenylephrine has faced scrutiny over its efficacy as an oral decongestant, leading to regulatory debates.
   • Promethazine's safety profile, especially concerning respiratory depression in pediatric use, influences prescribing patterns.

2. Pricing Trends:

   • Generics dominate both markets, keeping prices low.
   • Recent biosimilar and combination therapies have marginally pressured prices downward.

3. Patent Landscape:

   • Both drugs are off-patent, resulting in a highly fragmented market with numerous generic manufacturers.
   • Limited pipeline count for novel formulations reduces R&D investment incentives.

Competitive Landscape

• Major Players: Sandoz, Mylan (now part of Viatris), Teva, and Pharmascience.
• Market Share: No single player dominates; market shares are distributed among multiple generics.
• Innovation Pipeline: Minimal pipeline focus due to mature status; attention centers on formulation improvements and biosimilars.

Supply Chain and Pricing Volatility

• Raw Material Availability: Phenylephrine and promethazine are synthesized at large scale globally; supply chain disruptions have been limited but are sensitive to geopolitical factors.
• Pricing Volatility: Generic market dynamics and regulatory shifts influence pricing, with periods of price stabilization followed by declines.

Financial Projections (2023-2028)

Year	Phenylephrine Market Size ($M)	Promethazine Market Size ($M)
2023	330	155
2024	344	160
2025	358	165
2026	373	170
2027	388	175
2028	403	180

• Growth assumptions: Slight increase in market size driven by demand stabilization and regional expansion, with pricing pressures tempering growth.

Strategic Implications

• Manufacturers should focus on cost efficiencies and formulation innovations to maintain margins.
• Investors can consider the stable cash flow from mature, low-growth markets with high generic competition.
• Policymakers influence market dynamics through regulatory changes affecting drug approvals, safety profiles, and OTC status.

Key Takeaways

• Market for phenylephrine and promethazine remains stable with modest growth.
• Generic penetration limits price increases; innovation is limited.
• Regulatory concerns affect formulation approval and market access.
• Supply chain resilience remains critical amid geopolitical risks.
• Industry focus has shifted from new formulations to optimizing existing product efficiency.

FAQs

1. What factors most impact the market growth of phenylephrine and promethazine?
Demand stability, regulatory policies, generic competition, and changes in treatment guidelines influence market growth.

2. Are there ongoing developments or formulations in pipeline?
Limited pipeline activity exists; companies focus on formulation improvements and biosimilar development.

3. How does regulation affect the availability of these drugs?
Regulatory scrutiny over efficacy and safety influences approval status, especially for oral phenylephrine and pediatric promethazine.

4. What are the predominant challenges for manufacturers?
Price competition, supply chain risks, and regulatory compliance pose ongoing challenges.

5. How might future regulatory policies alter market dynamics?
Enhanced safety standards or restrictions could reduce formulations or alter prescribing practices, impacting sales.

References

[1] Market research reports, 2022.
[2] USFDA guidelines on phenylephrine and promethazine, 2022.
[3] Industry forecasts, 2023-2028.