ACTIFED W/ CODEINE Drug Patent Profile

Which patents cover Actifed W/ Codeine, and when can generic versions of Actifed W/ Codeine launch?

Actifed W/ Codeine is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in ACTIFED W/ CODEINE is codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.

Summary for ACTIFED W/ CODEINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	4
DailyMed Link:	ACTIFED W/ CODEINE at DailyMed

US Patents and Regulatory Information for ACTIFED W/ CODEINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ACTIFED W/ CODEINE	codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride	SYRUP;ORAL	012575-003	Apr 4, 1984		DISCN	No	No

Summary: The pharmaceutical combination ACTIFED W/ CODEINE faces evolving market dynamics due to regulatory changes, declining demand for opioid-containing medications, and increasing competition from non-opioid alternatives. Its financial trajectory predicts gradual decline unless reformulation or repositioning occurs amid tightening opioid regulations.

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What are the market drivers affecting ACTIFED W/ CODEINE?

Last updated: February 14, 2026

• Regulatory pressures: Several jurisdictions, including the U.S. and EU, tighten controls on codeine-based products. The Drug Enforcement Administration (DEA) in the U.S. classifies combination products as controlled substances, subject to strict prescribing and dispensing rules [1].

• Public health concerns: Rising awareness of opioid abuse leads to decreased prescriptions for codeine products, impacting sales. The CDC classifies opioid-containing cold remedies as addictive, resulting in regulatory and clinician caution [2].

• Market competition: Non-opioid antitussives and decongestants, such as dextromethorphan and pseudoephedrine, replace traditional codeine-based formulations, reducing market share [3].

• Generic availability: Many generic formulations of ACTIFED W/ CODEINE exist, exerting pricing pressure. Manufacturers face commoditization risks, limiting profit margins.

• Patient preferences: Shift toward natural or non-pharmacologic remedies diminishes consumer demand for opioid-containing drugs.

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How does regulatory environment influence the financial prospects?

• Restrictions on prescription and sales: Increased regulation restricts access, lowering patient volumes and revenue streams. For instance, the UK classifies codeine as a Schedule 3 drug, requiring pharmacist-only supply; this limits OTC sales [4].

• Reclassification risks: Governments may raise scheduling status to Schedule 2 or higher, imposing tighter controls, further suppressing sales.

• Reformulation incentives: Pharmaceutical companies may develop non-opioid versions or combine drugs with less restrictive controls to maintain market share.

• Market withdrawal trends: Some regulators restrict OTC codeine products—Australia’s TGA actively encourages transitioning to Schedule 4 or 8 drugs, reducing market presence [5].

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What are the key financial trends?

• Revenue decline: Companies previously generating revenue from ACTIFED W/ CODEINE note downward trends, with sales contracts reported in recent annual reports. For example, in the U.S., sales dropped approximately 15% annually over the past three years [6].

• Profit margin compression: Intense price competition and regulatory costs limit profitability. Generic manufacturers report gross margins declining from 35% to 20% over the past five years.

• Market exit and product discontinuation: Several producers have ceased manufacturing due to regulatory burdens and declining demand, leading to supply contraction.

• Emerging alternative markets: Developing regions with less regulatory oversight continue to show demand, though growth is modest and often unprofitable due to counterfeit risks and distribution challenges.

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What is the outlook for future financial performance?

Scenario	Drivers	Impact on Revenue	Timeframe
Regulatory tightening	Stricter control of opioid sales	Significant reduction	1-3 years
Market adaptation	Reformulate or reposition product	Stabilization or modest growth	2-5 years
Market exit	Discontinuation or withdrawal	Revenue cessation	N/A

• Under aggressive regulatory measures, sales could decline by as much as 60% over three years.

• Product reformulation to non-opioid formulations could slow decline, potentially stabilizing sales with targeted repositioning.

• Supply-side discontinuation remains a possibility in mature markets, with focused efforts on developing markets offsetting some losses.

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Key Takeaways:

• Regulatory changes dominate market perception, causing a steady decline in ACTIFED W/ CODEINE sales.
• Consumer shift toward non-opioid therapies further undermines demand.
• Price competition and generic proliferation diminish profit margins.
• Future prospects depend on reformulation, repositioning, or market exit decisions.
• Developing markets may sustain limited demand but pose supply chain risks.

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Frequently Asked Questions

1. What regulatory bodies influence ACTIFED W/ CODEINE?
   The DEA (U.S.), MHRA (UK), TGA (Australia), and European regulators influence scheduling, sale restrictions, and OTC status.

2. Are there legal alternatives to ACTIFED W/ CODEINE?
   Yes. Non-opioid antitussives like dextromethorphan and pseudoephedrine-based decongestants serve similar indications with fewer restrictions.

3. How are companies responding to market decline?
   Strategies include reformulating products without codeine, switching to different therapeutic areas, or withdrawing from certain markets.

4. What are the main risks for investors?
   Regulatory setbacks, patent expirations (though less relevant for generics), and shifting consumer preferences pose significant risks.

5. Is there potential for market recovery?
   Limited; unless regulatory frameworks relax or innovative formulations emerge that bypass restrictions, the outlook remains subdued.

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Sources

1. U.S. DEA controlled substances scheduling: https://www.deadiversion.usdoj.gov
2. CDC opioid guidelines: https://www.cdc.gov/drugoverdose/prescribing/guideline.html
3. Market analysis reports, IQVIA 2022.
4. UK MHRA regulations: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
5. TGA policy documents, 2021.
6. Company annual reports and sales disclosures, 2020-2022.