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, Xgen Pharms, Altana, Norvium Bioscience, Polymedica, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Usl Pharma, Alpharma Us Pharms, Actavis Mid Atlantic, Cenci, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Ani Pharms, Xttrium Labs Inc, Delcor Asset Corp, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Strides Pharma, 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. Forty-seven suppliers are listed for this compound.

Summary for promethazine hydrochloride

US Patents:	0
Tradenames:	13
Applicants:	54
NDAs:	89
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	58
Patent Applications:	4,802
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
National Trauma Center	N/A
Oman Medical Speciality Board	Phase 3
Tanta University	N/A

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	SYRUP;ORAL	213890-001	Jul 12, 2021	AA	RX	No	No
Prinston Inc	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040622-003	Jul 18, 2006	AB	RX	No	No
Invatech	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	084233-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Prinston Inc	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040622-001	Jul 18, 2006	AB	RX	No	No
Sandoz	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	084176-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Market Dynamics and Financial Trajectory for Promethazine Hydrochloride

Introduction

Promethazine Hydrochloride, a versatile antihistamine and sedative, is gaining significant traction in the pharmaceutical industry. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of Promethazine Hydrochloride.

Market Size and Growth

The Promethazine Hydrochloride market is projected to experience substantial growth over the next decade. As of 2023, the market was valued at $XX million and is expected to reach $YY million by 2033, with a Compound Annual Growth Rate (CAGR) of ZZ% from 2024 to 2033[1].

Segmentation

The market is segmented based on several key factors:

Formulation Type

Promethazine Hydrochloride is available in various formulations, including tablets, injections, syrups, suspensions, and others. Each formulation type caters to different patient needs and preferences, contributing to the market's diversity and growth[1].

End User

The primary end users of Promethazine Hydrochloride include hospitals, clinics, pharmacies, homecare settings, and others. The demand from these segments is driven by the increasing need for effective allergy and sedation treatments[1].

Distribution Channel

The distribution channels for Promethazine Hydrochloride include online, offline, direct sales, pharmaceutical wholesalers, and others. The rise of online pharmacies and direct sales channels has enhanced accessibility and contributed to market growth[1].

Geographical Regions

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region presents unique opportunities and challenges, influenced by local healthcare policies and market dynamics[1].

Key Drivers

Several factors are driving the growth of the Promethazine Hydrochloride market:

Increasing Demand for Allergy Treatments

The rising incidence of allergies and the need for effective treatments are significant drivers. Promethazine Hydrochloride's multi-action properties in relieving allergies and inducing sedation make it a preferred choice among healthcare providers and patients[1].

Advancements in Formulation and Delivery Methods

Recent improvements in the formulation and delivery methods of Promethazine Hydrochloride have enhanced its effectiveness and safety. These advancements are aligned with the emerging patient-centered approach to care, which emphasizes personalized and efficient treatment options[1].

Launch of New Products

Companies like ANI Pharmaceuticals are launching new products, such as Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, which are timely and meet the increasing demand for cough and cold treatments. This launch is expected to drive strong growth in the generics business[2].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

Regulatory Hurdles

Changes in regulatory policies and FDA approvals can significantly impact the market. Delays or failures in obtaining approvals can hinder product commercialization and affect market growth[2].

Competition

The pharmaceutical market is highly competitive, with numerous generic alternatives to branded products. This competition can delay market entry and affect the pricing strategies of companies involved in the Promethazine Hydrochloride market[2].

Supply Chain Risks

Reliance on single-source suppliers for raw materials and active pharmaceutical ingredients can lead to production delays and increased costs, which can negatively impact the financial trajectory of the market[2].

Financial Performance

The financial performance of the Promethazine Hydrochloride market is robust, with significant revenue growth anticipated:

Revenue Projections

U.S. annual sales for Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution are approximately $42.6 million, based on July 2024 data. This figure indicates a strong market presence and potential for further growth[2].

Market Valuation

The global Promethazine Hydrochloride market is valued at $XX million in 2023 and is expected to grow to $YY million by 2033. This growth is driven by increasing demand, new product launches, and advancements in formulation and delivery methods[1].

Regional Analysis

The market performance varies across different regions:

North America and Europe

These regions are expected to dominate the market due to well-established healthcare systems and high demand for allergy treatments. The presence of major pharmaceutical companies and stringent regulatory frameworks also influence market dynamics in these regions[1].

Asia-Pacific

The Asia-Pacific region is emerging as a significant market due to its large population, increasing healthcare expenditure, and growing awareness of allergy treatments. This region offers substantial growth opportunities for companies involved in the Promethazine Hydrochloride market[1].

Competitive Landscape

The Promethazine Hydrochloride market is characterized by a competitive landscape with several key players:

Major Companies

Companies like ANI Pharmaceuticals, among others, are actively involved in the market. These companies are focused on launching new products, expanding their market share, and enhancing their product portfolios through strategic alliances and acquisitions[1][2].

Market Strategies

Key players are employing various strategies such as detailed profiling, SWOT analysis, and benchmarking to stay competitive. Custom research services and market analysis reports are also being utilized to understand market trends and opportunities better[1].

Technological Advancements

Technological advancements play a crucial role in the development and analysis of Promethazine Hydrochloride:

Analytical Methods

New methods, such as the ultra-violet estimation technique, have been proposed for detecting and determining the concentration of Promethazine Hydrochloride. These methods are easy, straightforward, and quick, enhancing the precision and accuracy of pharmaceutical formulations[5].

Consumer Behavior and ESG Analysis

Consumer behavior and Environmental, Social, and Governance (ESG) factors are increasingly influencing the pharmaceutical industry:

Patient-Centered Care

The shift towards patient-centered care is driving the demand for more effective and safe treatments. Promethazine Hydrochloride, with its multi-action properties, aligns well with this trend[1].

ESG Considerations

Companies are now more focused on ESG factors, which include environmental sustainability, social responsibility, and good governance practices. These factors can impact the market trajectory and the reputation of companies involved in the Promethazine Hydrochloride market[4].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the Promethazine Hydrochloride market:

Supply Chain Disruptions

The pandemic led to supply chain disruptions, affecting the production and distribution of pharmaceuticals. However, the increased focus on healthcare during the pandemic also boosted the demand for allergy treatments[4].

Key Takeaways

• Market Growth: The Promethazine Hydrochloride market is expected to grow significantly, driven by increasing demand for allergy treatments and advancements in formulation and delivery methods.
• Segmentation: The market is segmented by formulation type, end user, distribution channel, and geographical region.
• Key Drivers: Increasing demand for allergy treatments, new product launches, and patient-centered care are key drivers.
• Challenges: Regulatory hurdles, competition, and supply chain risks are significant challenges.
• Financial Performance: The market is financially robust, with projected revenue growth and significant market valuation.

FAQs

1. What are the primary formulation types of Promethazine Hydrochloride? The primary formulation types include tablets, injections, syrups, suspensions, and others[1].

2. Which regions are expected to dominate the Promethazine Hydrochloride market? North America and Europe are expected to dominate the market, with the Asia-Pacific region emerging as a significant growth area[1].

3. What are the key drivers of the Promethazine Hydrochloride market? Key drivers include increasing demand for allergy treatments, advancements in formulation and delivery methods, and the launch of new products[1][2].

4. How has the COVID-19 pandemic impacted the Promethazine Hydrochloride market? The pandemic has led to supply chain disruptions but also increased the focus on healthcare, boosting demand for allergy treatments[4].

5. What are the major challenges facing the Promethazine Hydrochloride market? Regulatory hurdles, competition from generic alternatives, and supply chain risks are significant challenges[2].

Sources

1. Verified Industry Insights - Global Dioxy Promethazine Hydrochloride Industry Report.
2. ANI Pharmaceuticals - Launch of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution.
3. Justdial - Antiemetic Market Dynamics.
4. Cognitive Market Research - Global Promethazine Hydrochloride Market Report 2024 Edition.
5. Journal of Medicinal and Pharmaceutical Chemistry - Ultra Violet Estimation of Promethazine HCl in Pharmaceutical Formulations.

Last updated: 2024-12-17