Codeine phosphate; promethazine hydrochloride - Generic Drug Details

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

Codeine phosphate; promethazine hydrochloride is the generic ingredient in five branded drugs marketed by Ani Pharms, Halsey, Actavis Mid Atlantic, Amneal Pharms, Hikma, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Wockhardt Bio Ag, and Cenci, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for codeine phosphate; promethazine hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	11
NDAs:	12
Finished Product Suppliers / Packagers:	6
DailyMed Link:	codeine phosphate; promethazine hydrochloride at DailyMed

Pharmacology for codeine phosphate; promethazine hydrochloride

Drug Class	Opioid Agonist Phenothiazine
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for codeine phosphate; promethazine hydrochloride

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

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

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

US Patents and Regulatory Information for codeine phosphate; promethazine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200894-001	Apr 24, 2013	AA	RX	No	No
Hikma	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	040151-001	Aug 26, 1997		DISCN	No	No
Ani Pharms	PHENERGAN W/ CODEINE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	008306-004	Apr 2, 1984		DISCN	Yes	No
Pharm Assoc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	089647-001	Dec 22, 1988		DISCN	No	No
Tris Pharma Inc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386-001	Jun 29, 2012	AA	RX	No	Yes
Pharm Assoc	PROMETHAZINE WITH CODEINE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	040650-001	Jan 31, 2006	AA	RX	No	No

Codeine phosphate; promethazine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Codeine Phosphate and Promethazine Hydrochloride

Introduction to Codeine Phosphate and Promethazine Hydrochloride

Codeine phosphate and promethazine hydrochloride are two pharmaceutical compounds with distinct therapeutic applications. Codeine phosphate is a semi-synthetic opioid used primarily for its analgesic, antitussive, and antidiarrheal properties, while promethazine hydrochloride is an antihistamine with sedative and antiemetic effects.

Codeine Phosphate Market Dynamics

Market Size and Growth

The codeine phosphate market was valued at USD 274.39 million in 2023 and is projected to reach USD 292.64 million in 2024, with a forecasted expansion to USD 489.81 million by 2032, growing at a CAGR of 6.65% during the forecast period[1][4].

Key Drivers

• Increasing Prevalence of Chronic Pain: The rising incidence of chronic pain conditions such as arthritis, cancer, and postoperative pain drives the demand for effective pain management solutions like codeine phosphate.
• Advancements in Drug Delivery Systems: Improvements in formulation technologies have enhanced the efficacy and safety profiles of codeine phosphate, making it a preferred choice among healthcare professionals.
• Expanding Healthcare Infrastructure: Growing healthcare investments in developing regions, particularly in Asia-Pacific, Latin America, and the Middle East, are increasing access to advanced medical treatments and pharmaceuticals[1][4].

Market Opportunities

• Novel Formulations: The development of extended-release formulations, combination therapies, and abuse-deterrent technologies offers significant opportunities for market growth and differentiation.
• Strategic Collaborations: Pharmaceutical companies can leverage strategic collaborations to enhance their competitive advantage and achieve sustainable growth[1].

Challenges

• Regulatory and Safety Concerns: The potential for addiction and side effects associated with long-term use of codeine phosphate can impede market growth.
• Generic Competition: The presence of generic drugs can create challenges for branded codeine phosphate products[4].

Promethazine Hydrochloride Market Dynamics

Market Size and Growth

The promethazine hydrochloride market is anticipated to grow steadily, driven by its extensive use in various therapeutic applications. The market is expected to reach USD 11.3 billion by 2031, growing at a CAGR of 7.99% from 2024 to 2031[2].

Key Drivers

• Increasing Prevalence of Allergies and Respiratory Conditions: The rising prevalence of allergies and respiratory conditions is driving the demand for effective antihistamines like promethazine hydrochloride.
• Healthcare Spending and Infrastructure: Growing healthcare expenditures and the expansion of the pharmaceutical sector are contributing to the market's growth.
• Regulatory Support: Regulatory support for the safe and effective use of promethazine hydrochloride in diverse medical contexts further strengthens the market[2].

Market Opportunities

• Emerging Markets: Regions such as Asia-Pacific, Latin America, and the Middle East offer significant growth opportunities due to increasing urbanization, rising disposable income, and improving healthcare infrastructure.
• Technological Advancements: Access to new technologies and intellectual property through mergers and acquisitions can enable companies to innovate faster and stay ahead of market trends[2].

Challenges

• Urbanization and Environmental Concerns: While urbanization drives demand, environmental concerns and stringent regulations may shift the market towards sustainable alternatives.
• Mergers and Acquisitions: While mergers and acquisitions can drive growth, they also present challenges in terms of market consolidation and competition[2].

Financial Trajectory for Codeine Phosphate

• Current Valuation: The codeine phosphate market was valued at USD 274.39 million in 2023.
• Projected Growth: It is expected to reach USD 292.64 million in 2024 and expand to USD 489.81 million by 2032, with a CAGR of 6.65% during the forecast period[1][4].

Financial Trajectory for Promethazine Hydrochloride

• Current Valuation: The promethazine hydrochloride market is valued at USD 6.6 billion in 2024.
• Projected Growth: It is anticipated to reach USD 11.3 billion by 2031, growing at a CAGR of 7.99% from 2024 to 2031[2].

Regional Insights

Codeine Phosphate

• North America: Dominates the codeine phosphate market due to the rising prevalence of chronic diseases and the strong presence of major market players.
• Asia-Pacific and Latin America: These regions are witnessing significant growth due to expanding healthcare infrastructure and increasing healthcare expenditures[1][4].

Promethazine Hydrochloride

• Asia-Pacific: A rapidly growing region driven by countries like China, Japan, India, and South Korea, with a large population and rising disposable income.
• Europe: Characterized by a mature market with well-established infrastructure and consumer preferences.
• Latin America and Middle East & Africa: Present opportunities and challenges, with economic fluctuations and political instability impacting market dynamics[2].

Technological and Regulatory Influences

Codeine Phosphate

• Advancements in Drug Delivery: Extended-release formulations and abuse-deterrent technologies are enhancing the safety and efficacy of codeine phosphate.
• Regulatory Support: Inclusion in essential medicine lists by health authorities enhances availability and affordability[1].

Promethazine Hydrochloride

• Regulatory Support: Regulatory approval for various therapeutic applications supports market growth.
• Technological Access: Mergers and acquisitions provide access to new technologies, enabling faster innovation and market competitiveness[2].

"Understanding these dynamics is crucial for stakeholders to navigate the market effectively and capitalize on emerging opportunities."[1]

Key Takeaways

• Codeine Phosphate: The market is driven by the increasing prevalence of chronic pain, advancements in drug delivery systems, and expanding healthcare infrastructure. It is expected to grow at a CAGR of 6.65% from 2024 to 2032.
• Promethazine Hydrochloride: The market is driven by the rising prevalence of allergies and respiratory conditions, growing healthcare spending, and regulatory support. It is expected to grow at a CAGR of 7.99% from 2024 to 2031.
• Regional Growth: Both markets see significant growth in Asia-Pacific, Latin America, and the Middle East & Africa due to improving healthcare infrastructure and increasing healthcare expenditures.

FAQs

What is the current market size and projected growth for the codeine phosphate market?

The codeine phosphate market was valued at USD 274.39 million in 2023 and is projected to reach USD 489.81 million by 2032, growing at a CAGR of 6.65% during the forecast period[1][4].

What are the key drivers of the promethazine hydrochloride market?

The key drivers include the increasing prevalence of allergies and respiratory conditions, growing healthcare spending, and regulatory support for its use in various therapeutic applications[2].

What are the challenges facing the codeine phosphate market?

The challenges include the potential for addiction and side effects associated with long-term use, as well as competition from generic drugs[4].

How is the promethazine hydrochloride market expected to grow in emerging regions?

The market is expected to grow significantly in regions like Asia-Pacific, Latin America, and the Middle East & Africa due to increasing urbanization, rising disposable income, and improving healthcare infrastructure[2].

What role do technological advancements play in the growth of these markets?

Technological advancements, such as extended-release formulations and abuse-deterrent technologies for codeine phosphate, and access to new technologies through mergers and acquisitions for promethazine hydrochloride, are crucial for enhancing market growth and competitiveness[1][2].

Sources

1. Global Growth Insights - Codeine Phosphate Market Share, Forecast, 2032
2. OpenPR - Promethazine HCL Market Size, Share and Forecast By Key Players
3. The Insight Partners - DXM and Codeine Syrup Market Opportunities 2031
4. Business Research Insights - Codeine Phosphate Market Size, Share, Growth, Trends 2032
5. Verified Industry Insights - Dioxy Promethazine Hydrochloride Market Analysis: Global Industry ...