ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE - Generic Drug Details

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

Acetaminophen; butalbital; caffeine; codeine phosphate is the generic ingredient in three branded drugs marketed by Able, Hikma, Hikma Intl Pharms, Lgm Pharma, Nostrum Labs Inc, Strides Pharma, Actavis Labs Ut Inc, and Valeant, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

US Patents:	0
Tradenames:	3
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	5
DailyMed Link:	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE at DailyMed

Pharmacology for ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Drug Class	Barbiturate Central Nervous System Stimulant Methylxanthine Opioid Agonist
Mechanism of Action	Full Opioid Agonists
Physiological Effect	Central Nervous System Stimulation

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; 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 ACETAMINOPHEN; 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
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076560-001	Jun 10, 2004	AB	RX	No	No
Hikma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	215138-002	Jan 26, 2022	AB	RX	No	No
Hikma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	215138-001	Jan 26, 2022	AB	RX	No	No
Valeant	PHRENILIN WITH CAFFEINE AND CODEINE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074911-001	Aug 22, 2001		DISCN	No	No
Able	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076528-001	Aug 21, 2003		DISCN	No	No
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076560-002	Jul 19, 2012	AB	RX	No	No

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE Market Analysis and Financial Projection Experimental

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

Introduction

The combination drug product consisting of acetaminophen, butalbital, caffeine, and codeine phosphate, commonly known as Fioricet with Codeine, is a significant player in the pharmaceutical market, particularly for the treatment of tension headaches. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Indications and Usage

Fioricet with Codeine is indicated for the relief of the symptom complex of tension (or muscle contraction) headaches. This drug combines the analgesic properties of acetaminophen and codeine, the barbiturate effects of butalbital, and the stimulant effects of caffeine[1][2][4].

Competitive Landscape

The market for headache treatments is competitive, with various pharmaceutical companies producing generic and branded versions of Fioricet with Codeine. Key players include Lannett, Mallinckrodt, Mikart, Qualitest, Watson, West-Ward, Teva, and Breckenridge. Despite the introduction of new innovator drugs for migraines, there remains a loyal following for Butalbital products[3].

Demand and Market Trends

Migraines and tension headaches are increasingly prevalent conditions in the United States, driving the demand for effective treatments. The loyal customer base and the ongoing need for analgesic solutions contribute to the stable demand for Fioricet with Codeine. However, the market is also influenced by the availability of alternative non-opioid and non-barbiturate analgesics[3].

Financial Performance

In fiscal year 2017, net sales of Butalbital products, including Fioricet with Codeine, totaled $19.6 million. This figure indicates a steady revenue stream, although it is lower compared to other pharmaceutical products. The financial performance is influenced by competition from both generic and branded products, as well as regulatory and safety concerns associated with the drug[3].

Regulatory Environment

Fioricet with Codeine is classified as a Schedule III controlled substance due to its potential for abuse and dependence. This classification necessitates strict regulatory oversight, including the implementation of an Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to manage risks associated with addiction, abuse, and misuse[2][4].

Safety and Risk Factors

The drug carries significant safety risks, including addiction, abuse, and misuse, as well as life-threatening respiratory depression, especially in children and adolescents. These risks necessitate careful patient selection and monitoring, which can impact prescribing rates and overall market performance[2][4].

Pharmacokinetics and Metabolism

The pharmacokinetics of Fioricet with Codeine involve the absorption, distribution, and elimination of its active ingredients. Butalbital, acetaminophen, and codeine are well absorbed from the gastrointestinal tract, with varying half-lives and elimination pathways. Understanding these pharmacokinetics is crucial for managing the drug's efficacy and safety profile[2].

Contraindications and Warnings

The drug is contraindicated in patients with hypersensitivity to any of its components, those with porphyria, and children under 12 years of age or adolescents with certain risk factors. It also carries boxed warnings for serious and life-threatening risks such as respiratory depression, accidental ingestion, and neonatal opioid withdrawal syndrome[1][2][4].

Impact of Generic Competition

The presence of generic versions of Fioricet with Codeine affects the market dynamics. Generic competition can reduce the market share of branded products but also ensures that the drug remains accessible to a broader patient population. However, generic versions must meet therapeutic equivalence standards set by regulatory bodies[3].

Future Outlook

Given the ongoing demand for headache treatments and the loyal customer base, the financial trajectory for Fioricet with Codeine is expected to remain stable. However, the market will continue to be influenced by regulatory changes, safety concerns, and the introduction of new treatments. Pharmaceutical companies must balance these factors to maintain market share and ensure patient safety.

Key Takeaways

• Market Indications: Fioricet with Codeine is primarily used for tension headaches.
• Competitive Landscape: Multiple pharmaceutical companies produce this drug, with a loyal customer base.
• Demand and Trends: Steady demand driven by prevalence of headaches, despite competition from new treatments.
• Financial Performance: Stable revenue, though lower compared to other pharmaceuticals.
• Regulatory Environment: Classified as a Schedule III controlled substance with strict oversight.
• Safety Risks: Significant risks including addiction, abuse, and respiratory depression.
• Pharmacokinetics: Well-absorbed ingredients with varying half-lives and elimination pathways.
• Contraindications and Warnings: Several contraindications and boxed warnings.
• Generic Competition: Affects market share but ensures accessibility.

FAQs

Q: What are the primary ingredients in Fioricet with Codeine? A: The primary ingredients are butalbital, acetaminophen, caffeine, and codeine phosphate.

Q: What is the main indication for Fioricet with Codeine? A: It is indicated for the relief of the symptom complex of tension (or muscle contraction) headaches.

Q: Why is Fioricet with Codeine classified as a controlled substance? A: It is classified as a Schedule III controlled substance due to its potential for abuse and dependence.

Q: What are the significant safety risks associated with Fioricet with Codeine? A: The drug carries risks of addiction, abuse, and misuse, as well as life-threatening respiratory depression.

Q: Can Fioricet with Codeine be used in children and adolescents? A: It is contraindicated in children under 12 years of age and in adolescents with certain risk factors.

Cited Sources

1. Fioricet with Codeine Label - FDA.
2. Butalbital/Acetaminophen/Caffeine/Codeine Capsules - eMPR.com.
3. Annual Report Fiscal Year 2017 - Lannett.
4. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Label - FDA.
5. ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE/ CODEINE CAP, ORAL - VA Formulary Advisor.