ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE - Generic Drug Details

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

Acetaminophen; caffeine; dihydrocodeine bitartrate is the generic ingredient in five branded drugs marketed by Mikart, Wraser Pharms Llc, Pharm Res Assoc, Leitner Pharms, Key Therap, Larken Labs Inc, Boca Pharma Llc, and West-ward Pharm Corp, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

US Patents:	0
Tradenames:	5
Applicants:	8
NDAs:	9
Finished Product Suppliers / Packagers:	1
DailyMed Link:	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE at DailyMed

Pharmacology for ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Drug Class	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; CAFFEINE; DIHYDROCODEINE BITARTRATE

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

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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; CAFFEINE; DIHYDROCODEINE BITARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leitner Pharms	SYNALGOS-DC-A	acetaminophen; caffeine; dihydrocodeine bitartrate	CAPSULE;ORAL	089166-001	May 14, 1986		DISCN	No	No
Key Therap	TREZIX	acetaminophen; caffeine; dihydrocodeine bitartrate	CAPSULE;ORAL	204785-001	Nov 26, 2014		DISCN	No	No
Mikart	ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	acetaminophen; caffeine; dihydrocodeine bitartrate	CAPSULE;ORAL	040109-001	Aug 26, 1997		DISCN	No	No
Boca Pharma Llc	ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	acetaminophen; caffeine; dihydrocodeine bitartrate	TABLET;ORAL	040701-001	Apr 3, 2007		DISCN	No	No
West-ward Pharm Corp	ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	acetaminophen; caffeine; dihydrocodeine bitartrate	TABLET;ORAL	040637-001	Sep 22, 2006		DISCN	No	No

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate

Introduction

Acetaminophen, caffeine, and dihydrocodeine bitartrate is a combination medication used to relieve moderate to moderately severe pain. This article will delve into the market dynamics and financial trajectory of this drug, exploring its usage, market trends, and financial implications.

Clinical Use and Indications

This combination medication is prescribed for managing pain that is severe enough to require an opioid analgesic and for which other treatments have not been effective or are not tolerated[1][2][4].

Market Demand

The demand for pain management medications, particularly those combining multiple active ingredients, remains high due to the prevalence of chronic pain conditions. Acetaminophen, caffeine, and dihydrocodeine bitartrate fills a niche in this market by offering a potent combination for moderate to moderately severe pain.

Competitive Landscape

The pain management market is highly competitive, with various opioid and non-opioid analgesics available. However, the specific combination of acetaminophen, caffeine, and dihydrocodeine bitartrate offers a unique profile that distinguishes it from other pain medications. Brands such as Dvorah, Panlor, and Trezix are prominent in this segment[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of any pharmaceutical product. Acetaminophen, caffeine, and dihydrocodeine bitartrate is classified as a DEA Schedule III drug, indicating a potential for abuse but also acknowledging its medical use. Regulatory guidelines from the FDA, such as those outlined in the draft guidance, ensure that generic versions meet bioequivalence standards, which can impact market competition[1][3].

Financial Performance

The financial performance of this drug is influenced by several factors, including prescription rates, insurance coverage, and competition from generic versions.

Prescription Rates

Given its specific indications, the drug is prescribed when other pain medications are ineffective or not tolerated. This targeted use ensures a steady demand, contributing to stable revenue streams.

Insurance Coverage

Insurance coverage is a significant factor in the financial trajectory of pharmaceuticals. Acetaminophen, caffeine, and dihydrocodeine bitartrate is typically covered by health insurance plans, which helps maintain market demand and revenue.

Generic Competition

The availability of generic versions can significantly impact the financial performance of branded drugs. For acetaminophen, caffeine, and dihydrocodeine bitartrate, generic competition is managed through bioequivalence testing and regulatory approvals, ensuring that generic versions meet the same efficacy and safety standards as the branded product[3].

Revenue Trends

The revenue generated by acetaminophen, caffeine, and dihydrocodeine bitartrate is stable due to its consistent demand and limited competition from exact generic equivalents. However, the overall revenue can fluctuate based on factors such as changes in prescription rates, new market entrants, and regulatory updates.

Cost and Pricing

The cost of the medication is a critical factor in its market dynamics. The pricing strategy must balance profitability with patient affordability and insurance reimbursement rates. The combination of acetaminophen, caffeine, and dihydrocodeine bitartrate is generally priced competitively within the pain management market, reflecting its value as a potent analgesic combination.

Patient and Physician Preferences

Patient and physician preferences also influence the market dynamics. The medication's effectiveness in relieving moderate to moderately severe pain, along with its relatively well-tolerated side effect profile, makes it a preferred choice among both patients and healthcare providers.

Side Effects and Safety Concerns

While the medication is effective, it comes with significant safety concerns, including the risk of addiction, abuse, and misuse. These risks must be carefully managed through patient selection and monitoring, which can impact market dynamics and financial performance[1][4].

Geriatric and Special Populations

The use of acetaminophen, caffeine, and dihydrocodeine bitartrate in geriatric patients and other special populations requires careful consideration due to potential age-related or condition-specific complications. This necessitates adjusted dosing and monitoring, which can affect market demand and financial outcomes[4].

Breastfeeding and Pregnancy Considerations

The medication's use in breastfeeding women is contraindicated due to harmful infant effects, which can reduce its market share in this demographic. Alternative medications are often prescribed, impacting the financial trajectory[4].

Market Projections

Given the stable demand for pain management solutions and the unique profile of acetaminophen, caffeine, and dihydrocodeine bitartrate, market projections indicate a continued presence in the pharmaceutical market. However, the impact of generic competition, regulatory changes, and evolving patient needs must be closely monitored.

Key Takeaways

• Stable Demand: The medication fills a specific need in pain management, ensuring consistent demand.
• Regulatory Environment: DEA Schedule III classification and FDA guidelines influence market competition and safety.
• Financial Performance: Stable revenue streams due to prescription rates, insurance coverage, and managed generic competition.
• Safety Concerns: Risks of addiction, abuse, and misuse must be managed carefully.
• Special Populations: Adjusted dosing and monitoring are necessary for geriatric and other special populations.
• Market Projections: Continued market presence with careful monitoring of competition and regulatory changes.

Frequently Asked Questions

Q: What are the primary components of acetaminophen, caffeine, and dihydrocodeine bitartrate?

A: The primary components are acetaminophen (a non-opiate analgesic and antipyretic), caffeine (a CNS and cardiovascular stimulant), and dihydrocodeine bitartrate (a semi-synthetic narcotic analgesic)[1][2][4].

Q: What are the common side effects of this medication?

A: Common side effects include difficulty having a bowel movement, relaxed and calm feeling, and sleepiness. Serious side effects can include respiratory depression, hypotension, and addiction[1][4].

Q: Is this medication safe for breastfeeding women?

A: No, the medication is contraindicated in breastfeeding women due to harmful infant effects[4].

Q: How does the regulatory environment impact this medication?

A: The medication is classified as a DEA Schedule III drug, and FDA guidelines ensure that generic versions meet bioequivalence standards, influencing market competition and safety[1][3].

Q: What are the market projections for this medication?

A: Market projections indicate a continued presence in the pharmaceutical market, with stable demand and managed generic competition, but with careful monitoring of regulatory changes and evolving patient needs.

Sources

1. DailyMed: Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsule.
2. Cleveland Clinic: Acetaminophen; Caffeine; Dihydrocodeine Capsules or Tablets.
3. FDA: Draft Guidance on Acetaminophen, Caffeine and Dihydrocodeine Bitartrate.
4. Mayo Clinic: Acetaminophen, caffeine, and dihydrocodeine (oral route).