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Last Updated: December 22, 2024

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE Drug Patent Profile


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Which patents cover Acetaminophen, Caffeine And Dihydrocodeine Bitartrate, and what generic alternatives are available?

Acetaminophen, Caffeine And Dihydrocodeine Bitartrate is a drug marketed by Larken Labs Inc and is included in one NDA.

The generic ingredient in ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

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Summary for ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE at DailyMed
Drug patent expirations by year for ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE

US Patents and Regulatory Information for ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Larken Labs Inc ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE acetaminophen; caffeine; dihydrocodeine bitartrate TABLET;ORAL 204209-001 Sep 30, 2016 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ACETAMINOPHEN, CAFFEINE AND 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 drug used to relieve moderate to moderately severe pain. This medication combines the analgesic and antipyretic properties of acetaminophen, the central nervous system (CNS) stimulant effects of caffeine, and the opioid analgesic properties of dihydrocodeine bitartrate. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Demand and Patient Needs

The demand for pain relief medications is consistently high due to the prevalence of chronic and acute pain conditions. Acetaminophen, caffeine, and dihydrocodeine bitartrate cater to this demand by offering a multi-mechanism approach to pain management, making it a valuable option for patients requiring opioid analgesics[1][4].

Competitive Landscape

The pain relief market is highly competitive, with various opioid and non-opioid analgesics available. However, the unique combination of acetaminophen, caffeine, and dihydrocodeine bitartrate sets it apart. This combination is particularly effective for patients who require both immediate pain relief and a CNS stimulant to enhance the analgesic effect[4].

Regulatory Environment

The drug is classified as a Schedule III controlled substance due to its opioid component, which imposes certain regulatory restrictions. The FDA and DEA closely monitor the prescribing and distribution of such medications to mitigate the risk of abuse and addiction[1][3].

Economic Factors

The cost of acetaminophen, caffeine, and dihydrocodeine bitartrate can vary depending on the manufacturer, dosage form, and geographical location. Generally, it is priced competitively within the pain relief market, making it accessible to a wide range of patients. However, the cost can be a barrier for some, especially those without adequate insurance coverage.

Pharmaceutical Industry Trends

The pharmaceutical industry is shifting towards more personalized and multi-mechanism therapies. The combination of acetaminophen, caffeine, and dihydrocodeine bitartrate aligns with this trend, offering a tailored approach to pain management. This alignment can contribute to its market stability and growth[5].

Geriatric and Pediatric Considerations

The drug's use in geriatric patients requires caution due to age-related health issues such as lung, liver, kidney, or heart problems. For pediatric patients, the risk of respiratory depression and other serious side effects necessitates careful dosing and monitoring[4].

Side Effects and Safety Concerns

The medication comes with several potential side effects, including respiratory depression, liver damage from acetaminophen, and the risk of addiction and physical dependence from dihydrocodeine. These safety concerns can impact market dynamics, as healthcare providers and patients weigh the benefits against the risks[1][4].

Genetic Considerations

Genetic variations, particularly in the CYP2D6 and CYP3A4 enzymes, can affect the metabolism of dihydrocodeine, leading to variations in efficacy and safety. Prescribing information often includes guidance on adjusting treatment based on genetic information, which can influence prescribing patterns and market demand[5].

Financial Performance

The financial performance of acetaminophen, caffeine, and dihydrocodeine bitartrate is influenced by several factors, including prescription rates, insurance coverage, and competition from other pain relief medications. The drug's classification as a Schedule III controlled substance also impacts its distribution and sales.

Market Projections

Given the ongoing need for effective pain management solutions, the market for acetaminophen, caffeine, and dihydrocodeine bitartrate is expected to remain stable. However, the landscape is subject to changes in regulatory policies, advancements in pain management therapies, and shifts in patient preferences.

Challenges and Opportunities

One of the significant challenges is the risk of addiction and abuse associated with opioid components. However, this also presents an opportunity for pharmaceutical companies to develop safer, abuse-deterrent formulations. Additionally, the growing awareness of personalized medicine could drive demand for tailored pain management solutions like this combination drug.

Key Players and Market Share

Several pharmaceutical companies, including Xspire Pharma, LLC, manufacture and distribute acetaminophen, caffeine, and dihydrocodeine bitartrate. The market share is distributed among these players based on factors such as pricing, distribution networks, and brand recognition.

Pricing Strategies

Pricing strategies for this drug are critical in maintaining market share. Companies often balance the need to keep prices competitive with the necessity of ensuring profitability. Discounts, patient assistance programs, and negotiations with insurance providers are common strategies to make the drug more accessible.

Distribution and Accessibility

The distribution network for acetaminophen, caffeine, and dihydrocodeine bitartrate includes pharmacies, hospitals, and online retailers. Ensuring wide accessibility is crucial for maintaining market presence.

Public Health Impact

The public health impact of this medication is significant, as it provides relief to millions of patients suffering from pain. However, it also contributes to the broader issue of opioid use and potential misuse, highlighting the need for responsible prescribing and monitoring practices.

Future Outlook

The future outlook for acetaminophen, caffeine, and dihydrocodeine bitartrate is influenced by ongoing research into safer pain management options and regulatory changes. As the healthcare landscape evolves, this drug is likely to remain a valuable option for pain relief, albeit with continued scrutiny and monitoring.

Key Takeaways

  • High Demand: The drug meets a significant need for pain relief, ensuring consistent demand.
  • Regulatory Scrutiny: As a Schedule III controlled substance, it is subject to strict regulatory oversight.
  • Safety Concerns: Potential side effects and risks of addiction impact market dynamics.
  • Genetic Considerations: Genetic variations affect metabolism, influencing prescribing patterns.
  • Financial Stability: The drug's financial performance is stable but subject to market and regulatory changes.
  • Future Outlook: The medication will likely remain relevant but will be influenced by advancements in pain management and regulatory changes.

Frequently Asked Questions

1. What are the primary components of acetaminophen, caffeine, and dihydrocodeine bitartrate?

The primary components are acetaminophen (320.5 mg), caffeine (30 mg), and dihydrocodeine bitartrate (16 mg)[1].

2. What are the common side effects of this medication?

Common side effects include difficulty having a bowel movement, relaxed and calm feeling, sleepiness, and others such as dizziness and dry mouth[4].

3. Can this medication be used in geriatric patients?

Yes, but with caution due to potential age-related health issues such as lung, liver, kidney, or heart problems[4].

4. Is this medication safe for breastfeeding mothers?

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

5. What are the risks associated with the opioid component of this drug?

The risks include addiction, physical dependence, and respiratory depression, especially in children and individuals with certain health conditions[1][4].

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