Acetaminophen; butalbital; caffeine - Generic Drug Details

What are the generic drug sources for acetaminophen; butalbital; caffeine and what is the scope of patent protection?

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

Thirty-seven suppliers are listed for this compound.

Summary for acetaminophen; butalbital; caffeine

US Patents:	0
Tradenames:	10
Applicants:	34
NDAs:	60
Finished Product Suppliers / Packagers:	37
Clinical Trials:	1
DailyMed Link:	acetaminophen; butalbital; caffeine at DailyMed

Recent Clinical Trials for acetaminophen; butalbital; caffeine

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

Sponsor	Phase
GlaxoSmithKline	Phase 3

See all acetaminophen; butalbital; caffeine clinical trials

Pharmacology for acetaminophen; butalbital; caffeine

Drug Class	Barbiturate Central Nervous System Stimulant Methylxanthine
Physiological Effect	Central Nervous System Stimulation

Anatomical Therapeutic Chemical (ATC) Classes for acetaminophen; butalbital; caffeine

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

N06BC	Xanthine derivatives
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for acetaminophen; butalbital; caffeine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lannett Co Inc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	212083-001	Dec 17, 2019	AA	RX	No	No
Lannett Co Inc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	212082-001	Dec 17, 2019	AA	RX	No	No
Dr Reddys Labs Sa	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	089007-001	Mar 17, 1986	AA	RX	No	Yes

Acetaminophen; butalbital; caffeine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Acetaminophen, Butalbital, and Caffeine

Introduction

The combination of acetaminophen, butalbital, and caffeine is a widely used medication for treating tension headaches and other types of pain. This drug, often marketed under brand names like Fioricet, has a complex market dynamics and financial trajectory that is influenced by several factors.

Therapeutic Indications and Mechanism of Action

This combination drug is primarily indicated for the relief of tension headaches and other pain conditions. Acetaminophen acts as an analgesic and antipyretic, inhibiting the synthesis of prostaglandins responsible for pain and inflammation. Butalbital, a barbiturate, functions as a central nervous system depressant, providing muscle relaxation and sedative effects. Caffeine enhances the pain-relieving effects of the other components and helps in the absorption of the drug[1][2][4].

Regulatory Approval and Compliance

The drug has successfully completed all necessary clinical trials and has been granted regulatory approval for use in patients. For instance, Granules India received USFDA approval for Butalbital, Acetaminophen, and Caffeine Capsules USP, highlighting the rigorous testing and safety standards met by this medication[3].

Market Competition

The market for this combination drug is competitive, with several pharmaceutical companies involved in its development and distribution. Companies like AbbVie, Inc. and Granules India are key players, with a strong focus on this therapeutic target. The United States is a leading region in the development of drugs targeting the A1R, A2aR, COX, and GABAA receptors[1].

Financial Performance

The financial performance of Butalbital, Acetaminophen, and Caffeine Capsules is significant. For example, the US sales of Butalbital, Acetaminophen, and Caffeine Capsules USP (50 mg/300 mg/40 mg) were approximately $42 million for the twelve months ending in February 2020[3].

Brand Names and Generic Versions

The drug is available under several brand names, with Fioricet being the most common. Generic versions are also widely available, contributing to the drug's market penetration and affordability. The presence of both branded and generic options ensures a competitive pricing strategy, which can impact the financial trajectory of the drug[4].

Risk of Dependence and Regulatory Status

Butalbital, a component of this drug, poses a risk of dependence and misuse. While the combination itself is not a federally controlled substance, some states classify it as such. The DEA has proposed removing the exemption for BAC, which could potentially add all products containing butalbital to the list of Schedule III controlled substances. This regulatory landscape can influence the market dynamics and financial performance of the drug[4].

Side Effects and Safety Considerations

The combination of acetaminophen, butalbital, and caffeine can cause several side effects, including liver damage from acetaminophen overdose and stomach irritation. These safety considerations can affect prescription rates and patient compliance, thereby impacting the financial trajectory of the drug. It is crucial for patients to follow the prescribed dosage and avoid taking the drug with other acetaminophen-containing medications to prevent serious side effects[2][4].

Geriatric and Pediatric Use

The drug's use in geriatric patients requires caution due to potential age-related kidney problems, which may necessitate dose adjustments. There are limited studies on the use of this medication during breastfeeding, and its use in pediatric patients is generally not recommended due to the risk of dependence and other side effects[2].

Market Trends and Future Outlook

The market for pain relief medications, including the combination of acetaminophen, butalbital, and caffeine, is driven by the increasing prevalence of headaches and other pain conditions. The synergistic effect of the three components makes this drug an effective option for treating tension headaches, which is a common condition affecting a significant portion of the population.

Key Players and Market Share

Companies like Granules India and AbbVie, Inc. hold significant market share due to their strong focus on the development and distribution of this drug. The approval of generic versions by the USFDA further intensifies the competition, ensuring that the market remains dynamic and competitive[1][3].

Regional Market Analysis

The United States is a major market for this drug, with significant sales and a high level of competition among pharmaceutical companies. The regulatory environment in the US, including FDA approvals and DEA classifications, plays a crucial role in shaping the market dynamics[1][3].

Pricing and Reimbursement

The pricing of Butalbital, Acetaminophen, and Caffeine Capsules is influenced by the presence of both branded and generic versions. Generic options often offer a more affordable alternative, which can impact the revenue of branded products. Reimbursement policies by health insurance providers also play a role in the financial performance of the drug[3].

Conclusion

The combination of acetaminophen, butalbital, and caffeine is a significant player in the pain relief market, with a well-established therapeutic profile and regulatory approval. The market dynamics are influenced by factors such as competition, regulatory status, and safety considerations. Here are some key takeaways:

• Therapeutic Efficacy: The drug is effective in relieving tension headaches and other pain conditions due to its synergistic mechanism of action.
• Regulatory Approval: The drug has undergone rigorous testing and has been granted regulatory approval.
• Market Competition: The market is competitive with several pharmaceutical companies involved.
• Financial Performance: The drug generates significant revenue, with US sales of approximately $42 million in a recent 12-month period.
• Risk of Dependence: Butalbital poses a risk of dependence, which can impact prescription rates and regulatory status.
• Safety Considerations: The drug can cause side effects such as liver damage and stomach irritation, necessitating careful use.

FAQs

1. What are the primary components of the drug Butalbital, Acetaminophen, and Caffeine?

   • The primary components are butalbital, a barbiturate; acetaminophen, an analgesic and antipyretic; and caffeine, a stimulant that enhances pain relief[1][2][4].

2. What is the main therapeutic indication for this drug?

   • The main therapeutic indication is the relief of tension headaches and other pain conditions[2][3][4].

3. Is Butalbital, Acetaminophen, and Caffeine a controlled substance?

   • While the combination itself is not a federally controlled substance, some states classify it as such, and the DEA has proposed adding it to the list of Schedule III controlled substances[4].

4. What are the potential side effects of this drug?

   • Potential side effects include liver damage from acetaminophen overdose, stomach irritation, and the risk of dependence on butalbital[2][4].

5. Can this drug be taken with other medications containing acetaminophen?

   • No, taking this drug with other acetaminophen-containing medications can lead to serious side effects, including liver damage[4].

Sources

1. An In-depth Analysis of acetaminophen/butalbital/caffeine's R&D progress - Synapse Patsnap Blog
2. Butalbital, acetaminophen, and caffeine (oral route) - Mayo Clinic
3. Granules India gets USFDA approval for Butalbital, Acetaminophen and Caffeine Capsules - Economic Times
4. Butalbital-Acetaminophen-Caffeine: Uses and Side Effects - Healthline