HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE Drug Patent Profile

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

Hydrocodone Bitartrate And Homatropine Methylbromide is a drug marketed by Abhai Llc, Actavis Mid Atlantic, Genus Lifesciences, Ivax Sub Teva Pharms, Novel Labs Inc, Padagis Us, Pharmobedient, Sankalp Lifecare, and Sciegen Pharms. and is included in nine NDAs.

The generic ingredient in HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hydrocodone Bitartrate And Homatropine Methylbromide

A generic version of HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE was approved as homatropine methylbromide; hydrocodone bitartrate by AVANTHI INC on August 7^th, 2017.

Summary for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

US Patents:	0
Applicants:	9
NDAs:	9

US Patents and Regulatory Information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abhai Llc	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	207487-001	Feb 21, 2017	AA	RX	No	Yes
Pharmobedient	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	088008-001	Mar 3, 1983	AA	RX	No	No
Ivax Sub Teva Pharms	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	040285-001	Jul 19, 1999		DISCN	No	No
Sankalp Lifecare	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	210663-001	Jun 11, 2019		DISCN	No	No

Investment Scenario and Fundamentals Analysis for Hydrocodone Bitartrate and Homatropine Methylbromide

Last updated: February 20, 2026

Overview

Hydrocodone Bitartrate combined with Homatropine Methylbromide is a prescription opioid-anticholinergic combination marketed for cough suppression and pain relief. This drug, branded as Hycodan and similar products, aligns with the opioids sector, with notable influences from regulatory, patent, and market dynamics.

Market Dynamics

Market Size and Growth

• Global opioid market: Valued at approximately $11.4 billion in 2022, with an expected CAGR of 3.5% through 2030 ([1]).
• Segment focus: Cough suppressants containing hydrocodone and anticholinergic agents, such as Homatropine Methylbromide, represent niche segments within the broader opioid therapy market.

Key Players

• Major pharmaceutical companies: Purdue Pharma, Janssen, and generic manufacturers.
• Market share primarily divided among branded and generic products.

Regulatory Environment

• U.S. jurisdiction: Controlled substance scheduling (Schedule II) imposes restrictions on prescription, dispensing, and manufacturing.
• Global regulation: Stringent controls limit production and distribution, impacting supply chains.

Patent and Regulatory Status

• Patent expiration: Most immediate patents expired or nearing expiration (circa 2010–2020), leading to increased generic competition.

• Regulatory approvals:

  • Approved for cough suppression and pain management in multiple countries.
  • Pending or recent regulatory actions have aimed at restricting opioid prescriptions due to abuse potential.

Investment Considerations

Market Opportunities

• Increasing demand for combination medications in pain management.
• Growth potential in emerging markets with expanding healthcare infrastructure.
• Pipeline drugs with modified delivery systems or abuse-deterrent formulations.

Risks

• Regulatory crackdowns on opioids in several jurisdictions.
• Rising awareness of opioid misuse leading to tighter prescribing guidelines.
• Patent expirations causing revenue declines for branded formulations.
• Legal liabilities associated with opioid litigation.

Financial Fundamentals

Aspect	Details
Revenue Trends	Declined in markets heavily impacted by opioid restrictions, but stable or growing in regions with less restrictive policies.
Profitability	Margins squeezed by increased generic competition and regulatory compliance costs.
R&D Expenditure	Focused on reformulation and abuse-deterrent formulations to mitigate legal and regulatory risks.
Pipeline Potential	Limited, with some candidates targeting novel delivery systems; however, no major recent breakthroughs.

Patent and Competition Outlook

• The dominant thermodynamic formulation is off-patent.
• Competition from generics has driven prices down, diminishing revenue per unit.
• Few new formulations entering the market; focus on reformulation to extend patent life.

SWOT Analysis

Strengths	Weaknesses
Established market presence	Patent expiration reduces exclusivity
Known efficacy and safety profiles	Heavy regulation increases compliance costs

Opportunities	Threats
Potential reformulations with abuse deterrence	Regulatory bans and restrictions
Growing markets in countries with less opioid regulation	Litigation risks from misuse and addiction cases

Conclusions

Investment prospects for Hydrocodone Bitartrate and Homatropine Methylbromide hinge on regulatory environment shifts and market innovation. Patent expirations have intensified competition, while reformulation efforts aim to extend product lifecycle. Regulatory tightening constrains market access, especially in mature markets.

Key Takeaways

• The global opioid market faces pressure due to regulatory and societal concerns.
• The product's revenue depends heavily on geographic markets and regulatory changes.
• Patent expirations have increased generic competition, reducing revenues.
• R&D investments focus on abuse-deterrent formulations but face slow approval pathways.
• Growth in emerging markets offers prospects, though regulatory hurdles remain.

FAQs

1. What is the current patent status of Hydrocodone Bitartrate formulations?
   Most patents expired between 2010 and 2020, leading to widespread generic manufacturing.

2. How do regulatory changes impact investment in this drug?
   Stricter prescribing guidelines and crackdowns on opioid distribution diminish sales potential, risking revenue decline.

3. Are there reformulated versions with abuse-deterrent features?
   Yes. Several reformulations incorporate abuse-deterrent technologies, extending market life but often facing lengthy approval processes.

4. What legal risks are associated with investing in this drug?
   Litigation over opioid misuse and addiction remains active, exposing investors to potential financial liabilities.

5. What is the outlook for growth in emerging markets?
   Growing healthcare infrastructure and less restrictive regulatory regimes in some regions create growth opportunities.

References

[1] MarketWatch. (2023). Global opioid market size and forecast, 2022–2030.