Promethazine hydrochloride - Generic Drug Details

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

Promethazine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Wyeth Ayerst, Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt Bio Ag, Xgen Pharms, Altana, Norvium Bioscience, Pharmobedient, Polymedica, Able, Annora Pharma, Cosette, Padagis Israel, Sun Pharma Canada, Watson Labs Inc, Usl Pharma, Alpharma Us Pharms, Actavis Mid Atlantic, Cenci, Amneal Pharms, Chartwell Rx, Kv Pharm, Pharm Assoc, Quagen, Strides Pharma, Whiteworth Town Plsn, Ani Pharms, Delcor Asset Corp, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, and Bristol Myers Squibb, and is included in eighty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for promethazine hydrochloride. Fifty suppliers are listed for this compound.

Summary for promethazine hydrochloride

US Patents:	0
Tradenames:	13
Applicants:	52
NDAs:	89
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	65
Patent Applications:	6,043
What excipients (inactive ingredients) are in promethazine hydrochloride?	promethazine hydrochloride excipients list
DailyMed Link:	promethazine hydrochloride at DailyMed

Recent Clinical Trials for promethazine hydrochloride

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

Sponsor	Phase
Montefiore Medical Center	PHASE4
Texas Scottish Rite Hospital for Children	PHASE2
University of North Carolina, Chapel Hill	PHASE4

See all promethazine hydrochloride clinical trials

Pharmacology for promethazine hydrochloride

Drug Class

Phenothiazine

Medical Subject Heading (MeSH) Categories for promethazine hydrochloride

Anti-Allergic Agents

Antipruritics

Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for promethazine hydrochloride

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

R06AD	Phenothiazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for promethazine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Quagen	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040673-002	Mar 5, 2008	AB	RX	No	No
Watson Labs	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	INJECTABLE;INJECTION	084591-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbott	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	084166-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Promethazine Hydrochloride

Last updated: July 27, 2025

Introduction

Promethazine hydrochloride, a first-generation antihistamine with sedative, antiemetic, and anticholinergic properties, remains a vital component in the pharmacological landscape. Its applications span allergy relief, motion sickness prevention, nausea management, and sedation, positioning it as a historically significant drug. This analysis examines the evolving market dynamics and financial trajectory of promethazine hydrochloride, emphasizing factors influencing supply, demand, regulation, competitive landscape, and future outlook.

Market Overview and Historical Context

Promethazine hydrochloride was first synthesized in the 1940s and gained widespread use due to its efficacy in treating allergic conditions, nausea, and as a sedative. It is available in various formulations — tablets, syrups, injectables, and suppositories — and primarily marketed by major pharmaceutical companies worldwide. Despite the advent of newer agents with improved safety profiles, promethazine retains relevance in clinical settings, especially within hospital and emergency contexts.

Current Market Dynamics

Demand Drivers

1. Clinical Applications and Prescriptions

Promethazine is entrenched in hospital protocols for nausea and preoperative sedation, particularly in populations where alternative agents may be contraindicated (e.g., pediatrics, certain psychiatric conditions). Its role in combination therapies, such as in promethazine-codeine syrups, sustains demand, notably in regions with high respiratory infection and cough prevalence.

2. Regulatory Acceptance and Usage Trends

Regulatory agencies such as the FDA continue to approve promethazine formulations; however, safety concerns — notably, black box warnings regarding tissue injury, respiratory depression, and extrapyramidal symptoms — affect prescribing behaviors. These warnings influence medical guidelines and can dampen growth prospects.

3. Geographical Variations

Demand intensity varies by region. Developed markets exhibit stable or declining consumption due to the availability of newer, safer alternatives. Conversely, in emerging economies, promethazine remains a cost-effective therapeutic choice, supporting sustained demand.

Supply-Side Factors

1. Manufacturing and Supply Chain Considerations

Promethazine hydrochloride production involves standard chemical synthesis, with a relatively stable supply chain due to established manufacturing processes. However, supply chain disruptions in key manufacturing hubs (e.g., India and China) can impact availability and pricing dynamics.

2. Patent Status and Generics Market

As a generic drug, promethazine faces limited patent protections. Market competition primarily hinges on generic manufacturing rights, which keeps prices competitive and suppresses revenue growth potential for manufacturers.

Regulatory and Safety Challenges

The safety profile of promethazine, particularly the risk of tissue necrosis post-injection and respiratory depression, triggers regulatory scrutiny and influences clinical uptake. Some jurisdictions have issued restrictions or warnings, potentially limiting market accessibility and growth.

Competitive Landscape

Promethazine's market is predominantly generics-driven, with several pharmaceutical companies manufacturing and distributing it globally. While no new proprietary formulations dominate the market, alternative medications such as ondansetron and dimenhydrinate increasingly capture market share, especially in formal antiemetic indications.

Emerging Trends and Innovations

Long-term growth prospects for promethazine are modest. Continuous innovation in antiemetics, sedatives, and allergy medications—particularly those with better safety profiles—poses competitive pressure. There has been limited pipeline innovation around promethazine specifically; instead, focus shifts toward newer agents and combination therapies.

Financial Trajectory and Market Forecast

Revenue Trends

The overall market for promethazine hydrochloride is characterized by stagnation or slight decline in developed regions, driven by safety concerns and the availability of newer drugs. Nonetheless, in regions with limited healthcare budgets, especially in Asia, Africa, and Latin America, promethazine continues to serve as an affordable therapeutic mainstay, sustaining revenues.

Pricing Dynamics

The generic nature of promethazine ensures low pricing, thereby limiting revenue expansion opportunities. Manufacturers’ strategies encompass volume sales rather than premium pricing, with price competition further constraining profit margins.

Market Size and Future Forecasts

Preliminary data indicates that the global market for promethazine hydrochloride remains in the hundreds of millions of dollars, with regional variation. Market analysts predict a compound annual growth rate (CAGR) of approximately 1-2% over the next five years, primarily driven by increasing healthcare access in emerging markets rather than innovation or expansion in developed markets. Notably, the market's stability hinges on generic supply consistency and regional prescription practices.

Impact of Regulatory Changes

Increased safety regulation and precautionary measures could lead to further restrictions on promethazine’s use, particularly injectable forms. Such regulatory shifts are likely to marginally decrease market size, primarily in jurisdictions prioritizing patient safety.

Strategic Implications for Stakeholders

1. Manufacturers: Focus on cost-efficient, high-volume production and exploring formulations with improved safety profiles to mitigate regulatory risks.

2. Investors: View promethazine hydrochloride as a mature, stable asset with limited growth potential, primarily valuable within emerging market portfolios.

3. Healthcare Providers: Given safety warnings, clinicians should prioritize alternative agents where feasible, affecting future demand and prescribing patterns.

4. Regulators: Ongoing safety reviews may lead to market restrictions, influencing supply and availability.

Conclusion and Outlook

The market for promethazine hydrochloride is characterized by stability with limited growth prospects, spanning primarily low-margin, high-volume generic sales. While it remains integral in certain clinical settings, the increasing availability of safer, more effective antiemetics and sedatives constrains its expansion. Manufacturers and stakeholders must navigate evolving regulatory landscapes and regional demands, recognizing that future revenue streams are more likely derived from volume rather than innovation or premium pricing.

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Key Takeaways

• Stable Market Base: Promethazine hydrochloride continues to serve essential functions globally, especially in emerging economies where cost-effective treatments are prioritized.

• Regulatory and Safety Impact: Growing safety concerns suppress prescribing and market growth, requiring manufacturers to adapt through formulation improvements or diversification.

• Limited Innovation Agenda: R&D activity around promethazine remains minimal; the market’s future hinges on generic supply stability and regional demand dynamics.

• Regional Variations: Demand in developing regions supports ongoing sales, while developed markets observe decline, highlighting the importance of geographic diversification.

• Growth Outlook: Projected modest growth at 1-2% CAGR over the next five years, driven by access expansion rather than product innovation.

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FAQs

1. What are the primary clinical uses of promethazine hydrochloride today?
Promethazine is chiefly used for allergy relief, nausea and vomiting prevention, sedation, and motion sickness. It remains a standard in hospital protocols, especially for pediatric and postoperative care.

2. How do safety concerns impact the market for promethazine?
Regulatory warnings about adverse effects such as tissue necrosis and respiratory depression have led to cautious prescribing, reduced use in some regions, and restricts formulations and dosages, thereby constraining market growth.

3. What is the competitive landscape for promethazine hydrochloride?
The market is highly commoditized, dominated by generic manufacturers. Limited proprietary formulations exist, with competition largely based on price and supply efficiency.

4. Are there innovative developments related to promethazine?
Currently, there is minimal pipeline innovation focused specifically on promethazine. The focus is on safer alternatives and novel antiemetics, which further compress its market expansion potential.

5. What regions present growth opportunities for promethazine hydrochloride?
Emerging markets in Asia, Africa, and Latin America offer the most significant growth opportunities due to increasing healthcare access and reliance on cost-effective medications, despite regional safety regulations.

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Sources:
[1] Market research reports on antihistamines and antiemetics.
[2] Regulatory agency guidelines, including FDA black box warnings.
[3] Industry publications and pharmaceutical trade data.