Aspirin; butalbital; caffeine; codeine phosphate - Generic Drug Details

What are the generic sources for aspirin; butalbital; caffeine; codeine phosphate and what is the scope of patent protection?

Aspirin; butalbital; caffeine; codeine phosphate is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Sa, Esjay Pharma, Lgm Pharma, Stevens J, Watson Labs, and Allergan, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for aspirin; butalbital; caffeine; codeine phosphate

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	5
DailyMed Link:	aspirin; butalbital; caffeine; codeine phosphate at DailyMed

Pharmacology for aspirin; butalbital; caffeine; codeine phosphate

Drug Class	Barbiturate Central Nervous System Stimulant Methylxanthine Nonsteroidal Anti-inflammatory Drug Opioid Agonist Platelet Aggregation Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors Full Opioid Agonists
Physiological Effect	Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production

Anatomical Therapeutic Chemical (ATC) Classes for aspirin; butalbital; caffeine; codeine phosphate

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

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for aspirin; butalbital; caffeine; codeine phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Stevens J	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074951-001	Aug 31, 1998	AB	RX	No	Yes
Watson Labs	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074359-001	Aug 31, 1995		DISCN	No	No
Dr Reddys Labs Sa	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	203335-001	Oct 30, 2015		DISCN	No	No
Lgm Pharma	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	075231-001	Nov 30, 2001	AB	RX	No	No

Aspirin; butalbital; caffeine; codeine phosphate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aspirin, Butalbital, Caffeine, and Codeine Phosphate

Introduction

The combination drug consisting of aspirin, butalbital, caffeine, and codeine phosphate is widely used for the management of tension or muscle contraction headaches. This article delves into the market dynamics and financial trajectory of this medication, highlighting its indications, risks, market trends, and financial implications.

Indications and Usage

This combination drug is specifically indicated for the management of tension or muscle contraction headaches when other non-opioid analgesics and alternative treatments are inadequate. It combines the effects of a barbiturate (butalbital), a nonsteroidal anti-inflammatory drug (aspirin), a CNS stimulant (caffeine), and an opioid agonist (codeine phosphate)[1][3][4].

Market Demand

The demand for this medication is driven by the prevalence of tension headaches, which are among the most common types of headaches. The market is also influenced by the limited availability of effective alternative treatments for severe headache symptoms.

Patient Population

The patient population for this medication includes individuals suffering from frequent or severe tension headaches who have not responded adequately to other treatments. This includes a broad demographic, although elderly patients and those with certain health conditions may require special consideration due to potential side effects and interactions[2][4].

Risks and Limitations

Addiction, Abuse, and Misuse

One of the significant risks associated with this medication is the potential for addiction, abuse, and misuse, particularly due to the presence of codeine and butalbital. This has led to the implementation of the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program to mitigate these risks[1][3][4].

Life-Threatening Respiratory Depression

Another critical risk is the potential for serious, life-threatening, or fatal respiratory depression, especially upon initiation or following a dose increase. This necessitates close monitoring of patients[1][3].

Other Risks

Other risks include accidental ingestion, especially by children, which can result in fatal overdose, and complex interactions with cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors[1][3].

Market Trends

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of this medication. The need for prior approval and the restricted distribution program under the Opioid Analgesic REMS program can affect accessibility and prescribing patterns[4][5].

Competition

The market for headache medications is competitive, with various alternatives available, including non-opioid analgesics and other combination drugs. However, the specific formulation of aspirin, butalbital, caffeine, and codeine phosphate maintains a niche due to its efficacy in treating severe tension headaches[3].

Pricing and Reimbursement

The pricing of this medication can vary based on regional healthcare policies and reimbursement structures. In some cases, such as in the VA system, it may require a non-formulary drug request and prior approval, which can impact its financial trajectory[5].

Financial Trajectory

Revenue Streams

The revenue generated from this medication is substantial due to its widespread use in managing tension headaches. However, the financial performance is influenced by factors such as prescription rates, competition from other analgesics, and regulatory constraints.

Cost Considerations

The cost of developing and maintaining this medication, including the costs associated with the REMS program, can be significant. Additionally, the potential for legal and regulatory challenges related to opioid misuse can impact the financial stability of manufacturers[1][3].

Market Projections

Despite the risks and limitations, the market for this medication is expected to remain stable due to the ongoing need for effective headache treatments. However, growth may be tempered by increasing scrutiny of opioid-containing medications and the development of alternative therapies.

Key Players

The market for aspirin, butalbital, caffeine, and codeine phosphate includes several key players, such as Amneal Pharmaceuticals and Watson Pharmaceuticals, which manufacture and distribute these medications under various brand names like Fiorinal with Codeine[1][3].

Financial Impact on Manufacturers

Manufacturers face significant financial implications, including the costs of compliance with regulatory requirements, the potential for legal liabilities related to opioid misuse, and the need to invest in research and development to address emerging safety concerns.

Financial Impact on Healthcare Systems

Healthcare systems also bear the financial burden of managing patients on this medication, including the costs of monitoring for addiction and respiratory depression, as well as the treatment of adverse effects. The restricted distribution program adds an additional layer of complexity and cost[1][3][4].

Conclusion

The combination drug of aspirin, butalbital, caffeine, and codeine phosphate remains a critical treatment option for tension headaches despite its associated risks. The market dynamics are influenced by regulatory environments, competition, and the ongoing need for effective headache treatments.

Key Takeaways

• Indications: Used for managing tension or muscle contraction headaches when other treatments are inadequate.
• Risks: Potential for addiction, abuse, and misuse; life-threatening respiratory depression; and complex drug interactions.
• Market Trends: Influenced by regulatory environments, competition, and reimbursement structures.
• Financial Trajectory: Revenue streams are substantial but tempered by regulatory costs, legal liabilities, and the need for ongoing compliance.
• Key Players: Includes manufacturers like Amneal Pharmaceuticals and Watson Pharmaceuticals.

FAQs

Q: What are the primary components of the medication aspirin, butalbital, caffeine, and codeine phosphate?

A: The primary components are aspirin (a nonsteroidal anti-inflammatory drug), butalbital (a barbiturate), caffeine (a CNS stimulant), and codeine phosphate (an opioid agonist)[1][3][4].

Q: What are the risks associated with this medication?

A: The risks include addiction, abuse, and misuse, life-threatening respiratory depression, and complex interactions with other medications[1][3].

Q: Why is this medication subject to the Opioid Analgesic REMS program?

A: It is subject to the REMS program due to the risks of addiction, abuse, and misuse associated with the opioid component (codeine phosphate) and the barbiturate component (butalbital)[1][3][4].

Q: Can this medication be used in elderly patients?

A: Yes, but with caution. Elderly patients may have age-related health issues that require dose adjustments and careful monitoring[2][4].

Q: Is this medication safe for breastfeeding women?

A: No, studies have shown harmful infant effects, so an alternative medication should be prescribed or breastfeeding should be stopped while using this medicine[2][4].

Sources

1. DailyMed: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE capsule.
2. Mayo Clinic: Butalbital, acetaminophen, caffeine, and codeine (oral route).
3. FDA: Fiorinal with Codeine Label.
4. Mayo Clinic: Butalbital, aspirin, caffeine, and codeine (oral route).
5. VA.gov: ASPIRIN/ BUTALBITAL/ CAFFEINE/ CODEINE CAP, ORAL.