BUTALBITAL AND ACETAMINOPHEN Drug Patent Profile

Which patents cover Butalbital And Acetaminophen, and what generic alternatives are available?

Butalbital And Acetaminophen is a drug marketed by Dr Reddys Labs Sa, Granules, Alvogen, Anda Repository, Halsey, Lgm Pharma, Ne Rx Pharma, Pharmobedient, Quagen, Senores Pharms, and Watson Labs. and is included in thirteen NDAs.

The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.

Summary for BUTALBITAL AND ACETAMINOPHEN

US Patents:	0
Applicants:	11
NDAs:	13
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	7
DailyMed Link:	BUTALBITAL AND ACETAMINOPHEN at DailyMed

Recent Clinical Trials for BUTALBITAL AND ACETAMINOPHEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
GlaxoSmithKline	Phase 3

See all BUTALBITAL AND ACETAMINOPHEN clinical trials

Pharmacology for BUTALBITAL AND ACETAMINOPHEN

Drug Class

Barbiturate

US Patents and Regulatory Information for BUTALBITAL AND ACETAMINOPHEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	BUTALBITAL AND ACETAMINOPHEN	acetaminophen; butalbital	CAPSULE;ORAL	207313-001	Dec 27, 2017	AA	RX	No	Yes
Lgm Pharma	BUTALBITAL AND ACETAMINOPHEN	acetaminophen; butalbital	TABLET;ORAL	090956-001	Aug 23, 2011	AA	RX	No	Yes
Alvogen	BUTALBITAL AND ACETAMINOPHEN	acetaminophen; butalbital	TABLET;ORAL	205120-001	Oct 30, 2015		DISCN	No	No
Senores Pharms	BUTALBITAL AND ACETAMINOPHEN	acetaminophen; butalbital	TABLET;ORAL	214088-001	Apr 7, 2022	AA	RX	No	No

Butalbital and Acetaminophen Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 6, 2026

Butalbital-acetaminophen is a mature, genericized prescription headache product with limited pricing power, fragmented manufacturing, and declining long-term strategic value. The market is concentrated in low-cost generic tablets and capsules, commonly sold with caffeine as the Fioricet-equivalent combination. Revenue is not reported as a standalone category by major manufacturers, and no reliable public source supports a precise global market-size or drug-level revenue estimate.

The commercial outlook depends more on generic supply, state prescribing controls, pharmacy substitution, and safety restrictions than on patent exclusivity. The product has no meaningful remaining brand patent moat in the United States based on publicly available FDA Orange Book records and product labeling.

What is butalbital and acetaminophen used for?

Butalbital-acetaminophen is prescribed for the short-term relief of tension or muscle-contraction headaches. The common product contains:

Component	Common strength	Function
Butalbital	50 mg	Barbiturate sedative
Acetaminophen	300 mg or 325 mg	Analgesic
Caffeine, in many products	40 mg	Adjunct analgesic and stimulant

The best-known commercial formulation is Fioricet, generally containing butalbital 50 mg, acetaminophen 300 mg, and caffeine 40 mg. Equivalent products are marketed as generic butalbital, acetaminophen, and caffeine capsules or tablets. Products containing only butalbital and acetaminophen also exist, although the caffeine-containing combination has greater market recognition.

Butalbital is a central nervous system depressant with misuse, dependence, and withdrawal risks. Acetaminophen creates a separate hepatotoxicity risk when patients combine the product with other acetaminophen-containing medicines. The FDA-approved labeling limits treatment to short-term use and warns against excessive dosing and concurrent central nervous system depressants.[1]

What is the FDA regulatory status of butalbital and acetaminophen?

The FDA regulatory position is established but commercially fragmented.

Fioricet is associated with FDA-approved prescription labeling, while numerous generic products have been approved through abbreviated new drug applications. Butalbital is federally classified as a Schedule III controlled substance when combined with nonnarcotic analgesics such as acetaminophen, under the Controlled Substances Act.[2]

Regulatory issue	Status
Prescription requirement	Yes
FDA pathway for generics	ANDA approval
Federal controlled-substance schedule	Schedule III for qualifying butalbital combinations
Common dosage forms	Tablets and capsules
OTC status	No
Typical indication	Short-term tension-headache treatment
Biosimilar pathway	Not applicable
REMS requirement	No product-specific FDA REMS identified in standard labeling

State rules can impose tighter prescribing, refill, or controlled-substance monitoring requirements. Commercial demand is also affected by state prescription-monitoring programs and payer policies that favor non-barbiturate headache therapies.

The FDA has repeatedly emphasized the risk of acetaminophen-associated liver injury, especially when patients take several acetaminophen products at the same time.[3] That risk limits the potential for dose escalation and discourages chronic use.

What patents protect butalbital and acetaminophen products?

No significant active U.S. patent barrier is evident for the mature butalbital-acetaminophen market.

The underlying active ingredients are old. The principal commercial formulations have been available for decades, and the brand-era protection associated with the original products has expired. Public Orange Book records do not indicate a meaningful current patent estate that could prevent ANDA competition for standard Fioricet-equivalent tablets or capsules.[4]

Protection category	Current commercial significance
Active-ingredient patent	None of practical relevance
Original combination patent	Expired or commercially obsolete
Formulation patent	No significant barrier for standard products identified
Method-of-use patent	No meaningful blocking patent identified
Manufacturing patent	Potentially relevant to individual suppliers, but not a market-wide barrier
Regulatory exclusivity	No current new-drug exclusivity moat for the mature combination
Biosimilar exclusivity	Not applicable

Patent risk is therefore lower than regulatory and supply-chain risk. A manufacturer could still hold confidential manufacturing know-how, process controls, or narrow formulation rights, but those rights would not generally prevent competitors from selling conventional butalbital-acetaminophen products.

When does butalbital and acetaminophen lose exclusivity?

The product lost practical U.S. market exclusivity many years ago. Generic competition is already established, and the product is not approaching a future loss-of-exclusivity event in the way a patented branded medicine would.

The relevant commercial timeline is:

Period	Market development
1960s-1970s	Fioricet-type butalbital combinations introduced and commercialized
1980s-1990s	Brand and generic availability expands
2000s	Generic substitution becomes standard
2010s	Prescription monitoring and medication-overuse concerns increase
2020s	Mature, low-price generic market with fragmented suppliers

The practical result is that generic entry is no longer a future event. It is the existing market structure.

How many patents cover butalbital and acetaminophen?

For standard U.S. butalbital-acetaminophen products, no material set of active Orange Book patents appears to cover the core tablet or capsule market. The relevant competitive protection is based on FDA approval, manufacturing capability, controlled-substance compliance, and distribution access rather than patent exclusivity.

A patent count is less useful for this product than for a branded small molecule because:

1. The active ingredients are long established.
2. The common formulations are conventional.
3. Generic ANDA products are already marketed.
4. The product has no active biologic, device, or delivery-system barrier.
5. Manufacturers compete primarily on price, availability, and wholesaler contracts.

Patent litigation is therefore unlikely to be a central market event unless a supplier introduces a new delivery system, abuse-deterrent formulation, extended-release product, or other differentiated dosage form.

What formulations are protected by butalbital and acetaminophen patents?

The conventional immediate-release tablet and capsule formulations do not have an evident patent moat. Potentially protectable formulation categories could include:

• Extended-release butalbital products.
• Abuse-deterrent dosage forms.
• Modified-release capsules.
• Lower-acetaminophen formulations.
• Non-sedating or reduced-butalbital combinations.
• Novel delivery systems.

These products would face a difficult commercial tradeoff. A reformulated product could obtain new intellectual-property protection, but it would also need to overcome limited physician demand, generic substitution, controlled-substance concerns, and competition from migraine-specific therapies.

No established reformulated product has displaced the conventional Fioricet-equivalent market.

What is the Orange Book status of Fioricet and generic butalbital-acetaminophen?

The Orange Book is relevant primarily to the listed NDA and approved generic equivalents. Conventional generic butalbital-acetaminophen products are generally approved through ANDAs referencing the applicable reference product. The Orange Book does not create a new exclusivity period for every generic manufacturer.

The commercially important Orange Book conclusions are:

• Standard products are genericized.
• There is no apparent current patent listing capable of blocking ordinary ANDA competition.
• Paragraph IV litigation is not a major current feature of the market.
• Generic manufacturers do not receive a new market monopoly merely by obtaining approval.
• Product-specific listing status can change as manufacturers add, withdraw, or transfer applications.

FDA Drugs@FDA and the Orange Book remain the controlling sources for application-level approval and patent-listing data.[4,5]

Which companies manufacture or sell butalbital and acetaminophen?

The market is supplied by multiple generic manufacturers and contract manufacturers. Historical and current commercial participants have included Actavis, Amneal, Hikma, Mayne Pharma, West-Ward or related Hikma entities, and other ANDA holders, depending on the dosage form and product presentation.

The product market is difficult to map to a single originator because:

• Brand ownership has changed over time.
• Authorized generic and conventional generic channels overlap.
• Manufacturers may hold approvals without actively marketing every strength.
• Wholesaler supply may change by quarter.
• Shortages can shift market share rapidly.

Fioricet-branded products and generic equivalents compete in the same therapeutic category, but the brand has limited ability to sustain a large premium because pharmacists can substitute approved generic products.

How strong is the patent estate for butalbital and acetaminophen?

The patent estate is weak from an investment or licensing perspective.

Patent-strength factor	Assessment
Core composition protection	Weak or expired
Formulation protection	Limited for conventional products
Use protection	Weak; tension-headache use is established
Manufacturing protection	Potentially narrow and supplier-specific
Enforcement leverage	Low
Generic entry resistance	Low
Licensing value	Low unless tied to a differentiated formulation
Lifecycle-management potential	Limited

A buyer acquiring a conventional product would be purchasing regulatory approvals, supply contracts, manufacturing access, and distribution rights rather than durable patent protection.

What is the competitive landscape for butalbital and acetaminophen?

The product competes against several classes of headache treatments:

Competitive category	Examples	Commercial effect
Simple analgesics	Acetaminophen, ibuprofen, naproxen	Low-cost substitutes
Combination analgesics	Aspirin-acetaminophen-caffeine products	Direct non-barbiturate competition
Triptans	Sumatriptan and other triptans	Preferred for many migraine patients
CGRP therapies	Ubrogepant, rimegepant, atogepant, monoclonal antibodies	Higher-cost, targeted migraine alternatives
Muscle relaxants or other headache therapies	Varies by diagnosis	Substitute treatment options
Nonpharmacologic treatment	Behavioral and physical approaches	Reduces repeated acute-use demand

The main structural pressure is clinical. Butalbital combinations are associated with medication-overuse headache, dependence, sedation, and impaired cognition. Specialty and primary-care guidelines commonly favor limiting barbiturate-containing headache products and using diagnosis-specific treatments where appropriate.[6]

What is the financial trajectory for butalbital and acetaminophen?

The financial trajectory is mature to declining in strategic value, with intermittent volume support from chronic users and prescription inertia.

Public companies generally do not disclose revenue for butalbital-acetaminophen separately. Revenue is typically aggregated within generic prescription portfolios. A precise market-size estimate would require proprietary prescription, sell-through, or claims data.

The financial profile is nevertheless clear:

Financial driver	Direction
Unit price	Low and under generic pressure
Prescription volume	Mature, with long-term clinical pressure
Gross margin	Variable; vulnerable to price competition
Revenue visibility	Low at individual-product level
Supply volatility	Moderate to high
Brand premium	Limited
Patent-driven upside	Minimal
Acquisition value	Based on cash flow and supply position, not exclusivity

Revenue can rise temporarily when competitors experience shortages or withdraw from the market. That increase is usually volume- or price-driven and does not indicate durable market expansion. In a stable supply environment, competition tends to push prices downward.

For manufacturers, the product may still be attractive when it uses existing controlled-substance infrastructure, has reliable API access, and fills a portfolio gap. It is less attractive as a standalone development asset because the product has limited differentiation and little opportunity for premium pricing.

What generic entry risks exist for butalbital and acetaminophen?

Generic entry risk is already realized rather than prospective. The key risks to an incumbent are:

• Additional ANDA approvals.
• Price erosion after supplier entry.
• Loss of preferred wholesaler placement.
• Substitution toward caffeine-containing or different acetaminophen strengths.
• Manufacturing interruptions.
• Controlled-substance quota or compliance constraints.
• Acetaminophen safety restrictions.
• Reduced prescribing by clinicians concerned about dependence or medication-overuse headache.

A generic launch would not require a Paragraph IV strategy if no blocking patent remains. The likely path is a standard ANDA approval followed by commercial launch, subject to manufacturing readiness and controlled-substance compliance.

What patent litigation and Paragraph IV challenges affect the market?

No major active U.S. patent litigation or Paragraph IV campaign is central to the conventional butalbital-acetaminophen market based on the publicly established product structure and absence of a meaningful blocking patent estate.

Future litigation would be more likely to involve:

• ANDA product labeling.
• Trade dress or trademark rights.
• Product liability.
• Manufacturing quality.
• Controlled-substance distribution.
• A new extended-release or abuse-deterrent formulation.

Those issues differ from classic patent litigation over a still-exclusive branded drug.

What licensing deals affect butalbital and acetaminophen?

No major recent licensing transaction appears to define the conventional market. Historical transfers of Fioricet-related rights and generic product portfolios have occurred through corporate acquisitions, product divestitures, and marketing arrangements rather than high-value discovery or co-development partnerships.

Licensing economics are usually modest because the assets lack patent exclusivity. The principal negotiable rights are:

• NDA or ANDA ownership.
• Authorized-generic rights.
• Territory-specific marketing rights.
• Supply and contract-manufacturing agreements.
• Controlled-substance distribution permissions.
• Trademark rights for Fioricet or related names.

How does butalbital-acetaminophen compare with newer migraine drugs?

Butalbital-acetaminophen is cheaper but less differentiated and carries greater dependence and medication-overuse concerns. Newer migraine drugs have stronger clinical positioning and higher prices but face payer controls, prior authorization, and more substantial patent exposure.

Attribute	Butalbital-acetaminophen	Newer migraine therapies
Patent protection	Minimal	Often substantial
Price	Low	Moderate to high
Dependence risk	Material due to butalbital	Generally lower for non-barbiturate agents
Use case	Tension headache and legacy prescribing	Migraine-specific treatment or prevention
Generic competition	Extensive	Limited for recently launched agents
Commercial growth	Low	Higher for successful differentiated products
Regulatory risk	Safety and controlled-substance oversight	Label, payer, and postmarketing requirements

The product retains demand where low acquisition cost and historical prescribing patterns outweigh clinical disadvantages. It is unlikely to regain broad growth without a materially differentiated formulation or new clinical positioning.

What are the key commercial scenarios through the late 2020s?

The base case is continued generic availability, low pricing, and gradual volume erosion. A shortage-driven upside case could produce temporary revenue gains for manufacturers with reliable inventory. A downside case would involve additional prescribing restrictions, supplier exits, or stronger migration to migraine-specific therapies.

Scenario	Expected market effect
Base case	Stable-to-declining volume and continued price pressure
Supply shortage	Temporary price and share expansion for available suppliers
New restrictions	Lower prescribing and reduced chronic use
Product reformulation	Potential premium, but substantial development and adoption risk
Supplier consolidation	Better pricing for remaining manufacturers, but greater regulatory scrutiny
Expanded migraine alternatives	Long-term erosion of legacy use

Key Takeaways

• Butalbital-acetaminophen is a mature, genericized prescription product.
• The most recognized formulation is Fioricet, which commonly includes caffeine.
• Butalbital combinations are federally Schedule III controlled substances when paired with nonnarcotic analgesics.
• No meaningful current patent barrier appears to block conventional U.S. generic products.
• Paragraph IV litigation and biosimilar risk are not material to the standard market.
• Revenue is not publicly reported as a standalone category.
• Financial performance depends on generic pricing, supplier availability, distribution, and controlled-substance compliance.
• Long-term demand faces pressure from medication-overuse headache, dependence concerns, acetaminophen toxicity, and newer migraine therapies.
• The strongest commercial assets are regulatory approvals and reliable supply, not patents.
• A differentiated extended-release or abuse-deterrent formulation could create new IP value, but no established product currently changes the market structure.

FAQs

Is butalbital-acetaminophen still profitable for generic manufacturers?

It can generate recurring cash flow, but profitability depends on manufacturing cost, supplier competition, and distribution access. It is generally a portfolio product rather than a high-growth asset.

Does Fioricet have patent protection?

The conventional Fioricet-equivalent market does not appear to have a current patent estate capable of preventing ordinary generic competition. Trademark rights and product branding are separate from patent exclusivity.

Can a company launch a generic without challenging a patent?

Yes. Where no blocking patent remains listed for the relevant reference product, a manufacturer can pursue the applicable ANDA pathway without relying on a Paragraph IV certification.

Is butalbital-acetaminophen a controlled substance in every state?

Federal classification is Schedule III for qualifying combinations, but state prescribing, refill, monitoring, and dispensing requirements can be stricter.

Could a new butalbital formulation support premium pricing?

Only if it delivers a meaningful clinical or safety advantage, such as controlled release or abuse deterrence, and obtains payer and physician adoption. Conventional reformulation alone would face strong generic substitution pressure.

References

1. U.S. Food and Drug Administration. (n.d.). Fioricet prescribing information. DailyMed.
2. U.S. Drug Enforcement Administration. (n.d.). Controlled substance schedules.
3. U.S. Food and Drug Administration. (2011). Prescription acetaminophen products to be limited to 325 mg per dosage unit; boxed warning will highlight potential for severe liver failure.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.
5. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database.
6. American Headache Society. (2015). The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache, 55(1), 6-9.