FIORINAL W/CODEINE Drug Patent Profile

Which patents cover Fiorinal W/codeine, and what generic alternatives are available?

Fiorinal W/codeine is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in FIORINAL W/CODEINE is aspirin; butalbital; caffeine; codeine phosphate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine; codeine phosphate profile page.

Summary for FIORINAL W/CODEINE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for FIORINAL W/CODEINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	FIORINAL W/CODEINE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	019429-003	Oct 26, 1990		DISCN	Yes	No

Summary
The combination drug Fiorinal W/Codeine (butalbital, aspirin, caffeine, and codeine phosphate) presents limited investment potential due to market saturation, regulatory constraints, and declining prescription trends. While historically used for migraine relief, evolving medical guidelines, and the opioid crisis have reduced its utilization. Investment decisions should consider patent expirations, generic competition, FDA regulatory pathways, and potential shifts toward safer alternatives.

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What Is the Market Position of Fiorinal W/Codeine?

Fiorinal W/Codeine, introduced in the 1960s, combines butalbital, aspirin, caffeine, and codeine for acute migraine treatment. It has faced declining prescriptions owing to:

• The rise of triptans (e.g., Sumatriptan)
• Increased regulatory scrutiny over opioid-containing medications
• Concerns over dependency and abuse

In the U.S., sales peaked in the early 2000s but have since declined by approximately 70%. The market is now primarily composed of generic versions, with few branded formulations remaining. Data from IQVIA indicates annual prescriptions in the U.S. fall below 1 million units.

Regulatory Landscape and Patent/IP Status

Fiorinal W/Codeine is available as a generic drug, with no active patents listed beyond the original compound. The last patent for the original formulation expired in the early 2000s, opening the market to multiple generic manufacturers. The absence of exclusivity limits pricing power significantly.

FDA Approval specifics:

• Approved as a prescription drug, classified as a Schedule III opioid under the Controlled Substances Act.
• Limited opportunity for new formulations unless manufacturers pursue new delivery methods or reformulations.

Market Dynamics and Competitive Landscape

• Generic Competition: Dominates the market, pressuring margins and limiting profitability for innovator companies.
• Alternative Treatments: The rise of triptans (e.g., sumatriptan) has shifted prescribing patterns. Triptans are deemed more effective and pose fewer dependency risks.
• Opioid Regulations: Stricter prescribing restrictions and monitoring programs restrict usage.
• Off-Label Use & Abuse Concerns: Increased scrutiny reduces future prescribing potential.

Economic Fundamentals

• Limited revenue streams due to declining prescription volumes and patent expiration.
• Margins decrease further as generic manufacturers compete on price.
• No current pipeline or reformulation development publicly announced.
• Regulatory hurdles and societal trends decrease likelihood of revival.

Investment Implications

• High risk for companies relying on Fiorinal W/Codeine as a growth driver.
• Potential short-term income from legacy product sales but limited long-term upside.
• Opportunities may exist in niche markets or for companies developing new migraine formulations with improved safety profiles.
• Significant regulatory risk and societal pressure diminish attractiveness.

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Key Drivers for Future Performance

Factor	Impact	Details
Patent Status	Negative	Fully expired, no exclusivity
Prescription Trends	Declining	2010-2022 prescriptions down 70%+
Regulatory Environment	Restrictive	Opioid use under tighter controls
Market Competition	Intense	Multiple generic manufacturers
Innovation Pipeline	Absent	No announced reformulations

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Key Takeaways

• Fiorinal W/Codeine faces a shrinking market due to safety concerns and alternative therapies.
• Patent expirations and generic proliferation limit revenue potential.
• Regulatory restrictions on opioids reduce future prescribing.
• Investment is tied to legacy sales, with minimal prospects for growth.
• Opportunities exist only for niche reformulations or developments targeting safety or efficacy.

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FAQs

Last updated: February 4, 2026

1. Is Fiorinal W/Codeine a viable long-term investment?
No. The market has shrunk significantly, and regulatory pressures restrict growth.

2. What are the main competitive threats?
Generic competition, shift toward triptans and non-opioid treatments, and regulatory restrictions on opioid prescriptions.

3. Are there any opportunities for reformulation or new indications?
Potential exists in niche markets or for formulations emphasizing safety, but no current pipeline indicates active development.

4. How do regulatory changes impact the drug’s future?
Tighter controls on opioid prescribing and increased monitoring reduce usage, further limiting market potential.

5. Could patent or exclusivity extensions improve the outlook?
Unlikely; patent expirations occurred over two decades ago with no current exclusivity protections.

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Sources

[1] IQVIA Prescription Data, 2022
[2] FDA Drug Database
[3] Federal Register, Schedule III opioids, 2022
[4] Market research reports on migraine treatments, 2022