ACETAMINOPHEN; BUTALBITAL - Generic Drug Details

What are the generic drug sources for acetaminophen; butalbital and what is the scope of freedom to operate?

Acetaminophen; butalbital is the generic ingredient in twenty branded drugs marketed by Forest Pharms, Mallinckrodt, Dr Reddys Labs Sa, Granules, Valeant, Dunhall, Pharmobedient, Alvogen, Anda Repository, Halsey, Lgm Pharma, Ne Rx Pharma, Quagen, Senores Pharms, Watson Labs, Mikart, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma, Key Therap, Lannett Co Inc, Novast Labs, Nuvo Pharms Inc, Taro, Us Chem, Genus, Abhai Llc, Able, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Strides Pharma Intl, Sun Pharm Industries, Vintage Pharms, and Hikma Intl Pharms, and is included in eighty-two NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for ACETAMINOPHEN; BUTALBITAL

US Patents:	0
Tradenames:	20
Applicants:	41
NDAs:	82
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
DailyMed Link:	ACETAMINOPHEN; BUTALBITAL at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; BUTALBITAL

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

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

See all ACETAMINOPHEN; BUTALBITAL clinical trials

Pharmacology for ACETAMINOPHEN; BUTALBITAL

Drug Class

Barbiturate

US Patents and Regulatory Information for ACETAMINOPHEN; BUTALBITAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	040885-001	Nov 16, 2009	AA	RX	No	Yes
Abhai Llc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	211106-001	Sep 26, 2018	AA	RX	No	No
Strides Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	204649-001	Jul 8, 2020		DISCN	No	No
Nesher Pharms	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	211543-001	Jul 17, 2020		DISCN	No	No
Mallinckrodt	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	088758-001	Mar 27, 1985		DISCN	No	No
Strides Pharma Intl	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040511-001	Aug 27, 2003	AA	RX	No	Yes

ACETAMINOPHEN; BUTALBITAL Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Acetaminophen and Butalbital?

The combined market for acetaminophen and butalbital revolves around their use in pain management and headache treatment. Acetaminophen, a common over-the-counter analgesic and antipyretic, has a broad consumer base. Butalbital, a barbiturate, is primarily used in combination products for treating tension headaches and migraines.

Market Size and Growth

• The global analgesic pharmaceuticals market exceeded $25 billion in 2022, with acetaminophen comprising a significant share.
• The demand for over-the-counter (OTC) analgesics fuels volume growth, especially in North America and Europe.
• Prescription products containing butalbital account for a smaller segment, constrained by regulatory restrictions.

Regulatory Environment

• Acetaminophen faces regulatory scrutiny for hepatotoxicity risks. The FDA limits the maximum dose per dosing and warns against chronic overdose.
• Butalbital has increased regulatory restrictions due to potential dependence and abuse liability; several countries have restricted its prescription status or withdrawn it from markets.

Competitive Landscape

Key Players	Market Share	Focus
Johnson & Johnson	20%	OTC acetaminophen products
Sanofi	15%	Combination analgesic products
Local generic manufacturers	40%	Generic acetaminophen supplies

• OTC brands dominate the acetaminophen market, creating high price competition but stable demand.
• Butalbital-containing formulations are less prevalent, with fewer manufacturers due to regulatory hurdles.

Current Trends

• A shift toward combination analgesics with lower dependence potential.
• Rising interest in non-opioid migraine treatments, reducing demand for butalbital formulations.
• Increased focus on safety profiles encourages reformulation and reformulation of existing products.

How Do Financial Trajectories Evolve?

Revenue Projections

• The acetaminophen market is expected to grow at a compound annual growth rate (CAGR) of 2-3% through 2028, driven by population growth and demand for OTC pain relief.
• The market for butalbital-containing drugs contracts due to tighter regulations, with revenues declining at a CAGR of approximately 5% since 2020.

Profitability

• OTC acetaminophen products have high margins due to volume sales and low manufacturing costs.
• Prescription products with butalbital face margin pressure due to regulatory compliance costs and shrinking demand.

Pricing Trends

• Prices for generic acetaminophen remain stable but face downward pressure from increased competition.
• Branded formulations command higher prices but see limited growth.
• Butalbital combination products are priced higher but are less profitable amid declining use.

Investment and R&D

• Market participants invest less in butalbital R&D, prioritizing safer alternatives.
• Companies focus R&D on non-opioid, non-barbiturate migraine therapies, such as CGRP inhibitors.
• Market entry barriers are high for new formulations due to regulatory and patent challenges.

What Are the Regulatory Considerations?

• The FDA classified butalbital as a Schedule III controlled substance in 2018, reducing its availability and increasing oversight.
• Acetaminophen's safety concerns remain under review; recent advisories call for dosing limits and labeling improvements.
• EU regulators have imposed restrictions on combination products with barbiturates, influencing market dynamics globally.

How Does Pricing and Reimbursement Impact?

• OTC acetaminophen benefits from broad insurance coverage and OTC sales channels.
• Prescription products with butalbital are subject to stricter formulary review, limiting reimbursement and access.
• Price competition among generics constrains margins for acetaminophen manufacturers, while regulatory restrictions on butalbital limit pricing leverage.

What Are the Future Outlooks?

• The core acetaminophen market maintains stability, with growth driven by aging populations and increased pain management needs.
• Butalbital's decline continues as safer, more effective migraine therapies penetrate the market.
• Innovation focuses on combining acetaminophen with other active ingredients to expand indications and improve safety.

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Key Takeaways

• Acetaminophen commands a large, stable OTC market with slow but steady growth.
• Regulatory pressures hinder butalbital's market and lead to manufacturer withdrawal.
• The market's focus shifts toward safer, non-barbiturate alternatives for headache and pain management.
• Price competition and regulatory costs limit profitability for generic and branded acetaminophen products.
• Investment trends favor non-opioid, non-barbiturate drug development over traditional butalbital formulations.

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FAQs

1. What drives the demand for acetaminophen globally?
   Its widespread OTC availability, broad safety profile at recommended doses, and use in multiple formulations sustain demand.

2. Why is butalbital losing market share?
   Regulatory restrictions, abuse potential, and safer alternatives reduce its prescription and market presence.

3. How do regulatory changes affect these drugs?
   Stricter controls on butalbital decrease its market; dosage limits and safety advisories influence acetaminophen formulations.

4. What are the key challenges in developing new formulations?
   Regulatory hurdles, patent expirations, and the need for safety and efficacy improvements complicate innovation.

5. What is the outlook for generic drug manufacturers?
   Continued demand for inexpensive acetaminophen favors generics, but price competition limits margin growth.

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References

[1] Market research reports on analgesic pharmaceuticals.
[2] FDA regulatory updates on acetaminophen and butalbital.
[3] Industry analysis on headache medication trends.
[4] Patent and innovation reports in pain management therapeutics.