PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE Drug Patent Profile

Which patents cover Promethazine Hydrochloride And Codeine Phosphate, and when can generic versions of Promethazine Hydrochloride And Codeine Phosphate launch?

Promethazine Hydrochloride And Codeine Phosphate is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Chartwell Rx, Cosette, Hikma, Pharm Assoc, Pharmobedient, and Quagen. and is included in eight NDAs.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.

Summary for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	5
DailyMed Link:	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE at DailyMed

Pharmacology for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Drug Class	Opioid Agonist Phenothiazine
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Mid Atlantic	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	088763-001	Oct 31, 1984		DISCN	Yes	No
Pharmobedient	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	088875-001	Dec 17, 1984	AA	RX	No	No
Cosette	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386-001	Jun 29, 2012	AA	RX	No	Yes

Market Dynamics and Financial Trajectory for Promethazine Hydrochloride and Codeine Phosphate

Last updated: July 27, 2025

Introduction

Promethazine Hydrochloride combined with Codeine Phosphate remains a pivotal formulation within the analgesic and antitussive landscape. This combination capitalizes on promethazine’s antihistaminic and antiemetic properties, paired with codeine’s opioid-based cough suppressant and analgesic effects. As a controlled substance, its market trajectory is shaped by regulatory, clinical, and societal factors, demanding a nuanced analysis for stakeholders seeking strategic insight.

Global Market Overview

The demand for promethazine-codeine formulations predominantly stems from North America, Europe, and select Asian markets. North America, especially the United States, accounts for a significant market share owing to established prescription practices and high prevalence of respiratory conditions. Europe exhibits steady growth driven by aging populations and respiratory disease management. In Asia, expanding healthcare infrastructure and rising chronic cough cases propel future growth, although strict regulatory controls modulate supply dynamics.

The overall global pharmaceutical market for combination analgesics and antitussives, including promethazine-codeine, was valued at approximately USD 2 billion in 2022, with projections suggesting a compound annual growth rate (CAGR) of 3–4% through 2030 [1].

Market Drivers

1. Clinical Efficacy and Established Use

Promethazine-codeine’s longstanding presence in symptom management reinforces its appeal among clinicians. The combination effectively alleviates cough, upper respiratory symptoms, and nausea, especially in acute settings. Its familiarity enhances prescription rates, maintaining steady demand despite emerging therapies.

2. Regulatory Approvals and Patents

While several formulations are off-patent, regulatory approvals sustain their market presence. Limited patent protections for specific formulations permit generic manufacturers to capture significant market share, leading to competitive pricing and widespread availability.

3. Rising Respiratory Illnesses

Increased incidence of respiratory infections and chronic cough conditions—exacerbated by environmental pollution and urbanization—drive the demand for antitussives like promethazine-codeine. The COVID-19 pandemic further heightened awareness of respiratory symptom management, although restrictions limited outpatient prescriptions for controlled substances in some regions.

4. Prescribing Practices and Medical Guidelines

In regions where opioids are heavily regulated, physicians increasingly favor non-opioid alternatives, thereby constraining growth. Conversely, in jurisdictions with lenient restrictions, promethazine-codeine remains a preferred first-line therapy under strict medical supervision.

Market Restraints

1. Regulatory and Legal Challenges

Codeine’s status as a controlled substance limits mass distribution. Variations in regulations across countries, such as Brazil’s more permissive Schedule C restrictions versus stringent controls in the UK, create complex market access landscapes. Increasing regulatory scrutiny and calls to curb opioid dependence threaten the future availability and prescribing of promethazine-codeine formulations [2].

2. Rising Concerns over Opioid Dependence

Global awareness of opioid misuse has led to stricter prescribing guidelines. Several regions have introduced opioid stewardship programs, restricting dosages and durations, which directly impact sales volumes.

3. Competition from Alternative Therapies

Non-opioid antitussives, including centrally acting agents and newer non-addictive formulations, challenge promethazine-codeine’s market share. Advances in cough suppressant medications with better safety profiles are further reducing reliance on traditional opioids.

4. Public Health Initiatives and Prescription Monitoring Programs

Implementation of real-time prescription monitoring impairs over-prescription and diversion of codeine-containing medications. These initiatives, while beneficial for public health, can inadvertently constrain legitimate pharmaceutical sales.

Emerging Trends and Market Opportunities

1. Reformulation and Patent Strategies

Pharmaceutical companies are exploring reformulations with abuse-deterrent properties to address dependence issues, potentially restoring market viability. Additional patent protections for such formulations could establish competitive advantages.

2. Digital Health Integration

Leveraging telemedicine and digital prescription tracking offers opportunities for targeted distribution, particularly in regions with unmet respiratory illness burdens. These platforms can also facilitate adherence monitoring for prescribed regimens.

3. Focus on Safe Prescribing

Enhanced clinician education and stricter formulation standards promote safer prescribing practices. Such initiatives could buffer against regulatory crackdowns while sustaining legitimate markets.

4. Expansion into Emerging Markets

Market penetration into Southeast Asia, Africa, and Latin America hinges on regulatory harmonization, infrastructure development, and strategic partnerships. These regions present growth