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Last Updated: December 23, 2024

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE Drug Patent Profile


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When do Homatropine Methylbromide And Hydrocodone Bitartrate patents expire, and when can generic versions of Homatropine Methylbromide And Hydrocodone Bitartrate launch?

Homatropine Methylbromide And Hydrocodone Bitartrate is a drug marketed by Actavis Elizabeth, Avanthi Inc, and Novel Labs Inc. and is included in three NDAs.

The generic ingredient in HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE is homatropine methylbromide; hydrocodone bitartrate. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the homatropine methylbromide; hydrocodone bitartrate profile page.

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Summary for HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
Drug patent expirations by year for HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
Pharmacology for HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists

US Patents and Regulatory Information for HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE homatropine methylbromide; hydrocodone bitartrate TABLET;ORAL 040295-001 Dec 1, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Avanthi Inc HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE homatropine methylbromide; hydrocodone bitartrate TABLET;ORAL 207176-001 Aug 7, 2017 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novel Labs Inc HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE homatropine methylbromide; hydrocodone bitartrate TABLET;ORAL 091528-001 Apr 20, 2011 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

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocodone Bitartrate and Homatropine Methylbromide

Introduction

Hydrocodone bitartrate and homatropine methylbromide is a combination drug used for the symptomatic relief of cough in adults and, in some formulations, children over 6 years old. This article delves into the market dynamics and financial trajectory of this drug, highlighting its indications, risks, market trends, and financial aspects.

Indications and Usage

This drug combination is indicated for the symptomatic relief of cough in patients 18 years of age and older, although some formulations are approved for children as young as 6 years old[2][4][5].

  • Adults: It is commonly prescribed for adults with persistent coughs where the benefits of cough suppression outweigh the risks associated with opioid use.
  • Children: While some formulations are approved for children over 6, it is crucial to avoid use in children under 6 due to the risk of fatal respiratory depression.

Risks and Warnings

The use of hydrocodone bitartrate and homatropine methylbromide comes with significant risks, including:

  • Addiction, Abuse, and Misuse: Patients are at risk of opioid addiction, abuse, and misuse, which can lead to overdose and death[1][2][4].
  • Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or in high-risk patients[1][2][4].
  • Accidental Ingestion: Accidental ingestion, particularly by children, can result in fatal overdose[1][2].
  • Concomitant Use with CNS Depressants: Use with benzodiazepines or other CNS depressants can lead to profound sedation, respiratory depression, coma, and death[2][4].

Market Trends

The market for hydrocodone bitartrate and homatropine methylbromide is influenced by several factors:

  • Regulatory Environment: The drug is classified as a Schedule II opioid, which imposes strict regulations on its prescription and distribution. This classification can impact its market availability and growth[1][2][4].
  • Competition: The market for cough suppressants is competitive, with various other medications available. However, the specific combination of hydrocodone and homatropine maintains a niche due to its efficacy in certain patient populations.
  • Public Health Concerns: The opioid epidemic has led to increased scrutiny and stricter prescribing guidelines, which can affect the drug's market dynamics.

Financial Trajectory

The financial performance of hydrocodone bitartrate and homatropine methylbromide is shaped by several factors:

  • Sales and Revenue: Despite the risks associated with opioids, this drug combination continues to generate significant revenue due to its effectiveness in treating persistent coughs. However, sales may be impacted by regulatory changes and public health initiatives aimed at reducing opioid use.
  • Cost and Pricing: The cost of the drug can vary based on the formulation (tablets, oral solution) and the manufacturer. Pricing strategies often balance profitability with the need to maintain patient access.
  • Research and Development: Pharmaceutical companies may invest in research to develop safer alternatives or formulations that mitigate the risks associated with opioid use. These investments can impact the financial trajectory of the drug.

Manufacturer and Market Share

Several manufacturers produce hydrocodone bitartrate and homatropine methylbromide, including KVK-Tech, Inc., and Endo Pharmaceuticals Inc.[1][4].

  • Market Share: The market share of each manufacturer can fluctuate based on factors such as pricing, distribution networks, and regulatory approvals.

Patient and Prescriber Dynamics

The dynamics between patients and prescribers play a crucial role in the market for this drug:

  • Patient Demand: Patients with persistent coughs may seek effective relief, driving demand for this medication.
  • Prescriber Caution: Prescribers must balance the benefits of the drug against the risks, leading to careful patient selection and monitoring.

Economic Impact

The economic impact of hydrocodone bitartrate and homatropine methylbromide extends beyond direct sales:

  • Healthcare Costs: The drug's use can influence healthcare costs, particularly in terms of managing side effects and treating overdose cases.
  • Societal Costs: The broader societal costs, including the economic impact of opioid addiction and misuse, are significant and can affect the drug's market trajectory.

Future Outlook

The future outlook for hydrocodone bitartrate and homatropine methylbromide is complex:

  • Regulatory Changes: Stricter regulations and guidelines for opioid prescribing may reduce the drug's market share.
  • Alternative Treatments: The development of safer, non-opioid cough suppressants could challenge the market position of this drug.
  • Public Health Initiatives: Ongoing public health efforts to combat the opioid epidemic will continue to influence the drug's financial trajectory.

Key Takeaways

  • Indications and Risks: The drug is indicated for cough relief in adults and some children, but it carries significant risks including addiction and respiratory depression.
  • Market Trends: The market is influenced by regulatory changes, competition, and public health concerns.
  • Financial Trajectory: Sales and revenue are impacted by regulatory changes, public health initiatives, and the development of alternative treatments.
  • Manufacturer and Market Share: Multiple manufacturers compete in the market, with market share influenced by various factors.
  • Patient and Prescriber Dynamics: Careful patient selection and monitoring are crucial due to the drug's risks.

FAQs

Q: What is hydrocodone bitartrate and homatropine methylbromide used for? A: It is used for the symptomatic relief of cough in adults and, in some formulations, children over 6 years old.

Q: What are the significant risks associated with this drug? A: The risks include addiction, abuse, and misuse, respiratory depression, and accidental ingestion leading to fatal overdose.

Q: Why is this drug classified as a Schedule II opioid? A: It is classified as a Schedule II opioid due to its high potential for abuse and dependence.

Q: How does the regulatory environment impact the market for this drug? A: Stricter regulations and guidelines for opioid prescribing can reduce the drug's market share and impact its financial trajectory.

Q: What are the potential future challenges for this drug in the market? A: The development of safer, non-opioid cough suppressants and ongoing public health initiatives to combat the opioid epidemic are significant challenges.

Cited Sources

  1. DailyMed: Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution Liquid.
  2. FDA: ANTITUSSIVE HYCODAN® (Hydrocodone Bitartrate and Homatropine Methylbromide) TABLETS AND ORAL SOLUTION.
  3. NCBI Bookshelf: Hydrocodone - StatPearls.
  4. FDA: hydrocodone bitartrate and homatropine methylbromide tablet.
  5. Mayo Clinic: Hydrocodone and homatropine (oral route).

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