FIORINAL W/CODEINE Drug Patent Profile

When do Fiorinal W/codeine patents expire, and when can generic versions of Fiorinal W/codeine launch?

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 is one drug master file entry 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
Patent Applications:	31
Drug Prices:	Drug price information for FIORINAL W/CODEINE
DailyMed Link:	FIORINAL W/CODEINE at DailyMed

See drug prices for FIORINAL W/CODEINE

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

Fiorinal With Codeine Market Dynamics, Financial Trajectory, Patent Status, and Generic Competition

Last updated: September 19, 2026

Fiorinal with Codeine is a mature combination analgesic containing butalbital, aspirin, caffeine, and codeine phosphate. Its commercial trajectory is defined by generic substitution, opioid controls, limited clinical demand, and the absence of meaningful remaining patent protection. The product has little identifiable standalone revenue because manufacturers generally report combination-analgesic sales within broader portfolios rather than as a separate product.

What is Fiorinal with Codeine and how is it used?

Fiorinal with Codeine combines four active ingredients:

Component	Role
Butalbital	Barbiturate with sedative and muscle-relaxant activity
Aspirin	Nonsteroidal anti-inflammatory analgesic
Caffeine	Analgesic adjuvant
Codeine phosphate	Opioid analgesic

The FDA-approved product is indicated for the relief of tension or muscle-contraction headaches when non-opioid therapy is inadequate. The labeling states that evidence supporting safety and efficacy for recurrent headaches is limited and that the product carries risks associated with barbiturates, aspirin, and opioids.[1]

Fiorinal with Codeine is distinct from Fiorinal, which does not contain codeine, and Fioricet with Codeine, which substitutes acetaminophen for aspirin. The three products compete within the older barbiturate-containing headache market but have different regulatory and safety profiles.

What is the FDA regulatory status of Fiorinal with Codeine?

Fiorinal with Codeine is an approved prescription drug, but its commercial status differs from its regulatory status.

The FDA-approved formulation is generally identified as:

• Butalbital
• Aspirin
• Caffeine
• Codeine phosphate
• Oral capsule
• Prescription-only status
• Federal Controlled Substance Act Schedule III classification because of the codeine component

The FDA label includes boxed-warning and precautionary language addressing addiction, abuse, misuse, respiratory depression, neonatal opioid withdrawal, and interactions with central nervous system depressants.[1]

The product is also subject to FDA labeling requirements for opioid-containing medicines. State-level controls can be more restrictive than federal scheduling. Some states impose additional prescribing, refill, or monitoring requirements for products containing codeine and butalbital.

How does Fiorinal with Codeine compare with Fioricet with Codeine?

Product	Active ingredients	Principal regulatory concern
Fiorinal	Butalbital, aspirin, caffeine	Barbiturate dependence and aspirin-related toxicity
Fiorinal with Codeine	Butalbital, aspirin, caffeine, codeine	Combined barbiturate, opioid, dependence, and respiratory-depression risk
Fioricet with Codeine	Butalbital, acetaminophen, caffeine, codeine	Opioid and barbiturate risk plus acetaminophen hepatotoxicity

Fiorinal with Codeine has a narrower commercial opportunity than non-opioid headache combinations because prescribers must manage both opioid and barbiturate exposure.

When did Fiorinal with Codeine lose exclusivity?

Fiorinal with Codeine is a legacy product. Any original compound, formulation, or regulatory exclusivity associated with its initial approval expired decades ago. The commercial market is therefore driven by generic approvals, manufacturing economics, controlled-substance compliance, and distribution access rather than by patent exclusivity.

The relevant exclusivity conclusions are:

Exclusivity category	Current commercial significance
Original product patent	Expired
New chemical entity exclusivity	Expired
Original formulation exclusivity	Expired
Pediatric exclusivity	No material current impact
Orphan exclusivity	Not applicable
Current branded patent moat	No meaningful protection identified
Generic entry	Established

The FDA Orange Book is the primary source for listed patents and regulatory exclusivity. Legacy combination products with long-established generic equivalents generally have no active Orange Book patent barrier of commercial consequence.[2]

What patents protect Fiorinal with Codeine?

No active patent estate is known to provide significant market exclusivity for the conventional Fiorinal with Codeine capsule.

The product’s active ingredients are old, and the dosage form is a conventional immediate-release oral capsule. That combination makes it difficult to sustain a commercially meaningful patent position based on:

• The active pharmaceutical ingredients
• Standard capsule composition
• Conventional manufacturing
• Ordinary oral administration
• The historical headache indication

A theoretical patent could cover a new release profile, abuse-deterrent design, salt form, manufacturing process, or delivery system. Such a patent would need to protect a commercially differentiated product rather than the legacy capsule itself. No such reformulated platform has established a major market position for Fiorinal with Codeine.

How strong is the patent estate for Fiorinal with Codeine?

The patent estate is weak from a competitive-defense perspective.

Patent factor	Assessment
Composition-of-matter protection	Expired
Basic formulation protection	Expired or commercially irrelevant
Orange Book blocking patents	No material barrier identified
Generic substitution defense	Weak
Manufacturing complexity	Low to moderate
Patent litigation exposure	Low
Reformulation opportunity	Possible but unproven
Patent-based pricing power	Minimal

Manufacturing know-how can still affect product availability, but it does not create the same legal barrier as an enforceable patent. Controlled-substance quotas, supplier qualifications, quality systems, and distribution contracts are more relevant than intellectual-property exclusivity.

How many generic manufacturers compete with Fiorinal with Codeine?

Generic competition is established, although the number of active suppliers can vary by dosage strength, package size, wholesaler inventory, and manufacturing economics.

Generic versions are marketed by companies that participate in the U.S. abbreviated new drug application system. The relevant competitive set can include specialty-generic companies, diversified pharmaceutical manufacturers, and contract manufacturers. Product availability may change when a supplier discontinues a strength, encounters a manufacturing issue, or reallocates controlled-substance capacity.

Generic competition has several effects:

1. Wholesale acquisition prices remain constrained.
2. Pharmacies can substitute between equivalent products.
3. Manufacturer volume is concentrated among a small number of suppliers.
4. Temporary shortages can create short-lived pricing opportunities.
5. The brand has limited ability to preserve a premium without a differentiated service or distribution strategy.

FDA approval of an ANDA establishes pharmaceutical equivalence and bioequivalence to the reference product. It does not create a durable commercial moat for the generic manufacturer.[2]

What is the Orange Book status of Fiorinal with Codeine?

The Orange Book remains the authoritative source for:

• Reference-listed drug status
• Approved dosage forms and strengths
• Therapeutic equivalence codes
• Listed patents
• Regulatory exclusivity
• Marketing-status information

For a mature product such as Fiorinal with Codeine, the principal Orange Book issue is generic substitution rather than patent litigation. An AB-rated generic can generally be substituted at the pharmacy level under applicable state law and payer rules.

Orange Book status should not be confused with active commercial distribution. A product can remain approved while a particular brand or generic manufacturer stops marketing it. FDA records, manufacturer labeling, wholesaler listings, and pharmacy availability can therefore show different results.[2][3]

What is the market size for Fiorinal with Codeine?

There is no reliable public standalone revenue series for Fiorinal with Codeine. Manufacturers do not generally disclose revenue for this product separately, and public prescription datasets often combine it with other butalbital or codeine products.

The market is best characterized as:

• Mature
• Genericized
• Low-growth
• Fragmented by manufacturer
• Sensitive to controlled-substance policy
• Vulnerable to therapeutic substitution
• Too small for material reporting by diversified pharmaceutical companies

The product competes against:

• Generic Fiorinal
• Generic Fioricet
• Fioricet with Codeine
• Triptans
• Gepants
• Nonsteroidal anti-inflammatory drugs
• Acetaminophen combinations
• Preventive migraine therapies
• Nonpharmacologic headache management

The growth of migraine-specific therapies has reduced the strategic relevance of older combination analgesics for many patients. Fiorinal with Codeine remains relevant in selected headache-treatment settings, but its use is constrained by medication-overuse headache, dependence risk, sedation, and opioid stewardship.

What factors are driving the financial trajectory?

The financial trajectory is structurally declining or flat at best for the legacy product, with occasional short-term gains caused by supply disruptions.

Generic price erosion

Once several ANDA holders enter, pharmacy benefit managers and wholesalers exert strong price pressure. The product lacks patent protection that could support premium pricing.

Opioid stewardship

FDA opioid labeling, CDC prescribing guidance, state prescription-monitoring programs, and payer controls reduce the attractiveness of codeine-containing headache products.[1][4] These policies affect prescribing frequency, refill behavior, and prescriber willingness to initiate treatment.

Clinical substitution

Providers increasingly favor migraine-specific medicines or non-opioid regimens where clinically appropriate. Barbiturate-containing products are often avoided for frequent or chronic headache because of dependence and medication-overuse concerns.

Supply-chain economics

The product requires controlled-substance compliance and reliable access to codeine and butalbital. Small-volume products can become commercially unattractive when manufacturers face:

• Raw-material constraints
• Quality remediation
• Controlled-substance quota limits
• Low contract prices
• Packaging and serialization costs
• Wholesale inventory rationalization

Payer and pharmacy behavior

Formulary management can encourage substitution with lower-cost generic alternatives. Pharmacies may also limit inventory because controlled substances require additional security and recordkeeping.

What revenue exposure does Fiorinal with Codeine create for manufacturers?

For diversified pharmaceutical companies, direct revenue exposure is likely immaterial relative to major branded products or high-volume generic medicines. The business can still provide incremental portfolio revenue because:

• Manufacturing costs are relatively low for a conventional capsule.
• The product has an established prescription base.
• Regulatory development costs are limited for existing generic versions.
• A manufacturer can benefit from temporary competitor exits.

The principal downside is compliance and liability exposure. A low-revenue controlled-substance product can create disproportionate operational costs if it generates adverse-event reports, diversion concerns, manufacturing findings, or enforcement scrutiny.

The commercial value is therefore based on contribution margin and portfolio fit, not brand equity.

Which companies are challenging Fiorinal with Codeine?

The market is challenged primarily by generic manufacturers, not by a named innovator-led patent challenger. Because the product has long been genericized, current competition typically occurs through:

• ANDA approvals
• Pharmacy substitution
• Contract pricing
• Wholesale distribution
• Supply continuity
• Product-line consolidation

There is no material current Paragraph IV campaign comparable to litigation surrounding recently launched small-molecule products. Paragraph IV litigation is generally relevant when an ANDA applicant certifies that a listed patent is invalid, unenforceable, or not infringed. A legacy product without meaningful unexpired Orange Book patents offers little basis for sustained Paragraph IV litigation.[2]

What patent litigation or settlement agreements affect the product?

No major active patent litigation or settlement structure is associated with the conventional Fiorinal with Codeine market.

The absence of litigation is commercially important. It indicates that:

• Generic launch timing is not controlled by an active patent settlement.
• No authorized-generic strategy is publicly central to the market.
• Manufacturers compete mainly on price and supply.
• Litigation risk is more likely to arise from product liability, controlled-substance compliance, labeling, or manufacturing issues than from patent infringement.

What generic launch scenarios exist?

Base case: continued low-value generic supply

Multiple suppliers continue to market the product, with low prices and limited manufacturer investment. This is the most likely long-term outcome.

Shortage-driven pricing

One or more suppliers exit or experience manufacturing disruption. Remaining manufacturers gain temporary volume and negotiating leverage. The effect is usually reversible when supply returns.

Further market contraction

Prescribing declines because of opioid controls, headache-treatment substitution, or payer restrictions. Manufacturers discontinue low-volume strengths or package sizes.

Reformulated product strategy

A company could pursue an abuse-deterrent, modified-release, or non-opioid formulation. Such a strategy would require new clinical, regulatory, and commercial investment and would compete against newer headache treatments. It is not an extension of the existing Fiorinal with Codeine franchise.

What manufacturing and intellectual-property barriers remain?

The formulation is technically straightforward compared with sterile injectables, biologics, inhaled products, or complex modified-release systems. The main barriers are operational:

• Qualified suppliers for active ingredients
• Controlled-substance handling
• FDA manufacturing compliance
• Batch testing and release
• Serialization and traceability
• Secure distribution
• Demand forecasting
• Wholesale and pharmacy access

These barriers can cause supply volatility but do not support durable monopoly pricing. The manufacturing barrier is moderate operationally and weak legally.

How does Fiorinal with Codeine compare with competing headache drugs?

Attribute	Fiorinal with Codeine	Fioricet with Codeine	Triptans	Gepants
Generic availability	Established	Established	Broad for older agents	Limited or brand-led
Opioid exposure	Yes	Yes	No	No
Barbiturate exposure	Yes	Yes	No	No
Patent protection	None of material value	Generally limited for legacy products	Varies	Often stronger
Clinical positioning	Selected tension-headache use	Tension or mixed headache use	Acute migraine	Acute or preventive migraine
Pricing power	Low	Low	Moderate to low	Higher for branded agents
Regulatory scrutiny	High	High	Moderate	Moderate

Fiorinal with Codeine is commercially disadvantaged against newer therapies because it carries more safety restrictions while offering limited differentiation.

Key Takeaways

• Fiorinal with Codeine is a mature, genericized product containing butalbital, aspirin, caffeine, and codeine.
• Original patent and regulatory exclusivity have expired.
• No material active patent estate or Paragraph IV campaign is central to the current market.
• The Orange Book is relevant mainly for generic equivalence and marketing status, not for an active patent barrier.
• Standalone product revenue is not publicly disclosed in a dependable form.
• Financial performance is driven by generic pricing, supply continuity, controlled-substance compliance, and declining clinical preference.
• Shortages can create temporary volume and pricing gains, but the long-term market outlook is flat to declining.
• The largest commercial risks are opioid stewardship, medication-overuse concerns, generic substitution, and manufacturer withdrawal.
• Manufacturing complexity is manageable, while compliance and distribution requirements remain meaningful.
• The product has little strategic value as a branded franchise unless paired with a materially differentiated reformulation.

FAQs About Fiorinal With Codeine

Is Fiorinal with Codeine still available in the United States?

Generic versions may remain available even when branded distribution is limited or discontinued. FDA approval status and pharmacy availability are separate questions.

Is Fiorinal with Codeine a controlled substance?

Yes. The codeine-containing product is federally scheduled as a Schedule III controlled substance, subject to applicable federal and state requirements.

Can pharmacies substitute generic Fiorinal with Codeine?

An FDA-rated therapeutically equivalent generic may generally be substituted subject to state law, payer rules, and pharmacist practice requirements.

Does Fiorinal with Codeine have a market exclusivity period today?

No meaningful market exclusivity period remains for the established conventional product. Competition is primarily generic.

Could a company obtain new patents on a Fiorinal with Codeine reformulation?

A genuinely new formulation, delivery system, manufacturing process, or abuse-deterrent design could potentially support patent protection if it satisfies patentability requirements. Such protection would apply to the new product, not automatically to the legacy capsule.

References

1. U.S. Food and Drug Administration. (n.d.). Fiorinal with Codeine prescribing information.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations.
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database.
4. Centers for Disease Control and Prevention. (2022). CDC clinical practice guideline for prescribing opioids for pain: United States, 2022. MMWR Recommendations and Reports, 71(3), 1-95.