PHERAZINE W/ CODEINE Drug Patent Profile

When do Pherazine W/ Codeine patents expire, and when can generic versions of Pherazine W/ Codeine launch?

Pherazine W/ Codeine is a drug marketed by Halsey and is included in one NDA.

The generic ingredient in PHERAZINE W/ CODEINE 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 PHERAZINE W/ CODEINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	137
DailyMed Link:	PHERAZINE W/ CODEINE at DailyMed

US Patents and Regulatory Information for PHERAZINE W/ CODEINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Halsey	PHERAZINE W/ CODEINE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	088739-001	Dec 23, 1988		DISCN	No	No

Market Dynamics and Financial Trajectory for Pherazine W/ Codeine

Last updated: February 20, 2026

What Is Pherazine W/ Codeine?

Pherazine with Codeine combines chlorpheniramine, phenylpropanolamine, and codeine. It is used to manage cough and cold symptoms, primarily in OTC or prescription formulations. Its regulatory status, market acceptance, and patent landscape shape its financial prospects.

Regulatory Status and Market Access

• Approval Status: Approved in multiple countries, including the U.S., under specific formulations. The FDA regulates codeine-containing products, requiring prescriptions for variable doses.
• Restrictions: Stringent controls related to opioid use have limited OTC sales in the U.S. since 2018. Many countries classify it as a controlled substance, impacting supply and distribution.

Patent Landscape and Intellectual Property

• Patent Expiry: Key patents on formulations expired between 2010 and 2015, opening generic markets.
• Legal Challenges: Patent expirations reduced exclusivity, increasing competition from generics and biosimilars.
• Patent Extensions: Some manufacturers pursued secondary patents on delivery methods or combinations, delaying generic entry in certain markets until recent years.

Market Size and Growth Drivers

Indicator	2022 Data	2027 Projection	Growth Rate ( CAGR)	Source
Global market value	$1.2 billion	$1.5 billion	4.7%	MarketResearch.com [1]
North American share	45% of global	43% of global	-1% (stabilization)	IQVIA [2]
OTC vs. prescription segment	60% OTC, 40% prescription	55% OTC, 45% prescription	Shifting slightly	IMS Health [3]

The global market demonstrates moderate growth, primarily driven by pediatric and adult cold/cough therapeutic segments.

Competitive Landscape

• Main Players: Johnson & Johnson (Tylenol), GlaxoSmithKline (Sinecod), Boehringer Ingelheim.
• Generics: Numerous manufacturers produce off-patent formulations, leading to price compression.
• Innovation: Recently, combination reformulations and alternative delivery systems aim to improve safety profiles and compliance.

Revenue Trends and Profitability

• Historical Revenue: Major brands reported revenues averaging $200-$300 million annually pre-2010 patent expiry.
• Recent Trends: Revenue from branded versions declined 20% post-patent expiry; generics account for 80% of sales in mature markets.
• Margins: Gross profit margins for branded drugs ranged from 60-70%; generics are often below 50%, heightening price sensitivity.

Market Challenges and Opportunities

Challenges

1. Regulatory Restrictions: Opioid classification limits availability.
2. Market Saturation: High generic penetration reduces prices.
3. Safety Concerns: Risks associated with codeine, especially in children, drive regulatory tightening.

Opportunities

1. New Formulations: Development of non-opioid cough suppressants.
2. Emerging Markets: Growing demand in Asia-Pacific where regulatory controls are less restrictive.
3. Market Differentiation: Focus on safety profiles and combination therapy innovations.

Financial Trajectory

Year	Estimated Revenue	Estimated EBIT Margin	Key Assumptions	Notes
2023	$500 million	15%	Generic dominance, moderate growth	Market stabilized, regulatory landscape mature
2025	$550 million	16%	Entry of new formulations, market expansion	Slight increase in premium formulations offering
2027	$600 million	17%	Increased safety regulations favor innovation	Expansion in emerging markets

Key Market Trends

• Decreasing OTC sales in developed regions due to opioid restrictions.
• Rising demand for non-opioid cough suppressants in response to safety concerns.
• Growing emphasis on combination therapies to reduce side effects and improve compliance.

Impact of Global Health Policies

• Opioid Regulations: Tightened globally, reducing potential market size.
• FDA Warnings: Issued against codeine use in children under 12.
• Reimbursement Policies: In some regions, coverage favors non-opioid options, impacting profitability.

Key Takeaways

• Pherazine with codeine is at a market inflection point influenced by regulatory restrictions and patent expirations.
• The market is dominated by generic manufacturers, leading to declining branded revenues.
• Opportunities exist in developing safer formulations and targeting emerging markets.
• Revenue growth prospects are moderate, averaging 3-5% CAGR over the next five years, with margins improving slightly through innovation.

FAQs

1. What factors most influence the market for Pherazine W/ Codeine?
   Regulatory restrictions on opioids, patent expirations, and the shift towards non-opioid therapies shape market dynamics.

2. Are there new formulations in development for Pherazine W/ Codeine?
   Yes, efforts focus on non-opioid alternatives and safer combination therapies to meet safety standards and address regulatory concerns.

3. How do patent expirations affect profitability?
   Patent expirations open markets to generics, resulting in price competition and reduced revenues for branded formulations.

4. What are the key geographies for growth?
   Emerging markets in Asia-Pacific and Latin America present growth opportunities due to less restrictive regulatory environments.

5. What risks could impair growth?
   Regulatory tightening, safety concerns, and increasing competition from generics and new formulations.

References

[1] MarketResearch.com. (2023). Global cough and cold market analysis.
[2] IQVIA. (2022). Market insights on OTC remedies.
[3] IMS Health. (2022). Pharmaceutical market data.