Homatropine methylbromide; hydrocodone bitartrate - Generic Drug Details

What are the generic drug sources for homatropine methylbromide; hydrocodone bitartrate and what is the scope of freedom to operate?

Homatropine methylbromide; hydrocodone bitartrate is the generic ingredient in five branded drugs marketed by Genus, Abhai Llc, Actavis Mid Atlantic, Ivax Sub Teva Pharms, Nostrum Labs Inc, Novel Labs Inc, Padagis Us, Sciegen Pharms Inc, Wockhardt Bio Ag, Halsey, Actavis Elizabeth, Avanthi Inc, and King Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for homatropine methylbromide; hydrocodone bitartrate

US Patents:	0
Tradenames:	5
Applicants:	13
NDAs:	15
Finished Product Suppliers / Packagers:	6
DailyMed Link:	homatropine methylbromide; hydrocodone bitartrate at DailyMed

Pharmacology for homatropine methylbromide; hydrocodone bitartrate

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for homatropine methylbromide; hydrocodone bitartrate

A03BA	Belladonna alkaloids, tertiary amines
A03B	BELLADONNA AND DERIVATIVES, PLAIN
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

A03BB	Belladonna alkaloids, semisynthetic, quaternary ammonium compounds
A03B	BELLADONNA AND DERIVATIVES, PLAIN
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

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

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for homatropine methylbromide; hydrocodone bitartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nostrum Labs Inc	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	210663-001	Jun 11, 2019		DISCN	No	No
Avanthi Inc	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	homatropine methylbromide; hydrocodone bitartrate	TABLET;ORAL	207176-001	Aug 7, 2017	AA	RX	No	Yes
Novel Labs Inc	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	homatropine methylbromide; hydrocodone bitartrate	TABLET;ORAL	091528-001	Apr 20, 2011		DISCN	No	No

Homatropine methylbromide; 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, commonly known by the brand name Hycodan, is a combination medication used for the symptomatic relief of cough. This article delves into the market dynamics, financial trajectory, and key aspects of this drug.

Market Overview

The global market for hydrocodone bitartrate has experienced significant growth in recent years. Here are some key points:

• Market Size and Growth: The hydrocodone bitartrate market was valued at several billion dollars in 2023 and is projected to continue growing substantially until 2031. This growth is driven by increasing demand for cough relief medications and the expanding healthcare sector[3].

• Segmentation: The market is segmented by type (below 98% and above 98% purity), application (capsules, extended-release tablets, and oral solutions), and geography (North America, Europe, APAC, and others). Each segment contributes to the overall market dynamics and growth[3].

Indications and Usage

Hydrocodone bitartrate and homatropine methylbromide are indicated for the symptomatic relief of cough in adults and children 6 years of age and older.

• Dosage Forms: Available in tablets and oral solutions, each containing 5 mg of hydrocodone bitartrate and 1.5 mg of homatropine methylbromide per dose[2][4].

• Contraindications: The medication is contraindicated in children under 6 years, patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, and those hypersensitive to the ingredients[2][4].

Risks and Precautions

The use of hydrocodone bitartrate and homatropine methylbromide comes with several risks and precautions:

• Addiction, Abuse, and Misuse: The medication exposes users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Patients must be assessed for these risks before and during treatment[2][4].

• Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or in high-risk patients. Close monitoring is essential[2][4].

• Concomitant Use with CNS Depressants: Concomitant use with benzodiazepines or other CNS depressants can result in profound sedation, respiratory depression, coma, and death[2][4].

Market Drivers

Several factors drive the growth of the hydrocodone bitartrate market:

• Increasing Demand for Cough Relief: The rising incidence of respiratory diseases and the need for effective cough relief medications are key drivers[3].

• Expanding Healthcare Sector: The growth of the healthcare sector, particularly in developing regions, contributes to the increasing demand for pharmaceuticals, including hydrocodone bitartrate[3].

• Generic Market: The approval of generic versions, such as the one by Hi-Tech Pharmacal, increases market competition and accessibility, driving growth[1].

Market Restraints

Despite the growth, there are several restraints to consider:

• Regulatory Challenges: Strict regulations and the need for FDA approvals can slow down market entry for new products[1].

• Side Effects and Risks: The potential for addiction, abuse, and serious side effects like respiratory depression can limit the prescription and use of hydrocodone bitartrate and homatropine methylbromide[2][4].

• Competition: The presence of other cough relief medications and alternative treatments can compete with hydrocodone bitartrate products[3].

Financial Trajectory

The financial trajectory of hydrocodone bitartrate and homatropine methylbromide is promising:

• Revenue Projections: The market is expected to grow significantly from 2023 to 2031, with revenue projected to increase substantially during this period[3].

• Historical Sales: For example, the generic equivalent of Hycodan by Hi-Tech Pharmacal had sales of approximately $5 million in 2006, indicating a steady market presence[1].

• Key Players: Companies like Johnson Matthey, Noramco, and Sun Pharma are key players in the hydrocodone bitartrate market, contributing to its financial growth[3].

Regional Market Analysis

The market is analyzed across various regions:

• North America: This region is a significant market due to high healthcare spending and a large patient population[3].

• Europe and APAC: These regions also show substantial growth due to increasing healthcare needs and expanding pharmaceutical markets[3].

Consumer Behavior and Economic Factors

Consumer behavior and economic factors play crucial roles:

• Patient Awareness: Increasing patient awareness about available treatments and the importance of cough relief drives demand[3].

• Economic Factors: Economic stability and healthcare policies in different regions influence the affordability and accessibility of hydrocodone bitartrate products[3].

Key Takeaways

• Growing Market: The hydrocodone bitartrate market is experiencing rapid growth driven by increasing demand and expanding healthcare sectors.
• Risks and Precautions: The medication comes with significant risks, including addiction, abuse, and respiratory depression.
• Regulatory and Competitive Landscape: Strict regulations and competition from other treatments are key restraints.
• Financial Projections: The market is projected to grow substantially until 2031, with significant revenue increases expected.

FAQs

Q: What is the primary indication for hydrocodone bitartrate and homatropine methylbromide? A: The primary indication is for the symptomatic relief of cough in adults and children 6 years of age and older.

Q: What are the potential risks associated with hydrocodone bitartrate and homatropine methylbromide? A: The medication carries risks of addiction, abuse, misuse, and serious side effects like respiratory depression.

Q: Which companies are key players in the hydrocodone bitartrate market? A: Key players include Johnson Matthey, Noramco, and Sun Pharma, among others.

Q: What is the projected market growth for hydrocodone bitartrate until 2031? A: The market is expected to grow substantially, with significant revenue increases projected from 2023 to 2031.

Q: Are there any contraindications for hydrocodone bitartrate and homatropine methylbromide? A: Yes, the medication is contraindicated in children under 6 years, patients with significant respiratory depression, and those with certain other conditions.

Cited Sources

1. Hi-Tech Pharmacal Receives Approval for Hydrocodone Bitartrate and Homatropine Methylbromide Syrup - Biospace
2. ANTITUSSIVE HYCODAN® (Hydrocodone Bitartrate and Homatropine Methylbromide) - FDA
3. Global Hydrocodone Bitartrate Market - Market Research Intellect
4. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution - DailyMed