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Last Updated: December 22, 2024

HYDROCODONE BITARTRATE Drug Patent Profile


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Which patents cover Hydrocodone Bitartrate, and what generic alternatives are available?

Hydrocodone Bitartrate is a drug marketed by Alvogen, Mallinckrodt, Mikart, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Abhai Llc, Able, Actavis Labs Fl Inc, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Elite Labs Inc, Endo Operations, Epic Pharma Llc, Granules, Halsey, Ivax Pharms, Lannett Co Inc, Mutual Pharm, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sanaluz, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Ucb Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, Lgm Pharma, Acella, Actavis Mid Atlantic, Ivax Sub Teva Pharms, Nostrum Labs Inc, Padagis Us, Sciegen Pharms Inc, Wockhardt Bio Ag, Ani Pharms, Teva, and Mayne Pharma Inc. and is included in one hundred and fifty-five NDAs.

The generic ingredient in HYDROCODONE BITARTRATE is chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.

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Drug patent expirations by year for HYDROCODONE BITARTRATE
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Recent Clinical Trials for HYDROCODONE BITARTRATE

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SponsorPhase
National Institute on Drug Abuse (NIDA)Phase 1
Elysium Therapeutics, Inc.Phase 1
Medpace, Inc.Phase 1

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Pharmacology for HYDROCODONE BITARTRATE
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for HYDROCODONE BITARTRATE
Paragraph IV (Patent) Challenges for HYDROCODONE BITARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HYSINGLA ER Extended-release Tablets hydrocodone bitartrate 30 mg, 40 mg, 80 mg, and 100 mg 206627 1 2015-05-08
HYSINGLA ER Extended-release Tablets hydrocodone bitartrate 20 mg, 60 mg, and 120 mg 206627 1 2015-04-15
ZOHYDRO ER Extended-release Capsules hydrocodone bitartrate 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg 202880 1 2014-02-26

US Patents and Regulatory Information for HYDROCODONE BITARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Ny HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040757-001 Aug 25, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lgm Pharma HYDROCODONE BITARTRATE AND ASPIRIN aspirin; hydrocodone bitartrate TABLET;ORAL 205479-001 May 28, 2021 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040658-002 Mar 24, 2006 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal Pharms Ny HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642-002 Mar 18, 2004 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abhai Llc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 209037-001 Jun 21, 2017 AA RX 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

HYDROCODONE BITARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydrocodone Bitartrate

Introduction to Hydrocodone Bitartrate

Hydrocodone bitartrate is a widely used opioid medication, primarily prescribed for the management of acute and chronic pain. Its popularity and controversial status make it a significant player in the pharmaceutical market.

Market Size and Growth Projections

The hydrocodone bitartrate market has experienced substantial growth in recent years and is projected to continue this trend from 2023 to 2031. The market size is expected to expand significantly, driven by increasing demand for pain management solutions. According to market reports, the forecast period from 2024 to 2031 will see robust growth rates, indicating a sustained and significant expansion of the market[1][4].

Segmentation of the Market

The hydrocodone bitartrate market is segmented based on several key factors:

Type

  • Below 98%
  • Above 98%

These segments are crucial as they influence the market dynamics, with the purity level affecting the pricing, penetration, and regulatory oversight of the product[1][4].

Application

  • Hydrocodone Bitartrate Capsule
  • Hydrocodone Bitartrate Extended-Release Tablets
  • Hydrocodone Bitartrate Oral Solutions

Each application segment has its own market share and growth prospects, with extended-release formulations gaining traction due to their therapeutic benefits and reduced risk of abuse[1][3].

Geographical Regions

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa

North America, particularly the U.S., is the primary consumer of hydrocodone bitartrate, accounting for 99% of the global supply despite comprising only 4.4% of the global population[2].

Market Drivers

Several factors drive the growth of the hydrocodone bitartrate market:

Increasing Demand for Pain Management

The rising incidence of chronic pain conditions and the need for effective pain management solutions are key drivers. Hydrocodone bitartrate, being a potent opioid, fills this need effectively[2].

Therapeutic Benefits

The availability of extended-release formulations, such as Zohydro™ ER, provides an important therapeutic option for patients who need consistent pain relief without the acetaminophen component, reducing the risk of liver damage and other toxicities[3].

Regulatory Changes

The FDA's rescheduling of hydrocodone from Schedule III to Schedule II in 2014, along with limits on acetaminophen content, has influenced market dynamics. These changes aim to balance the medical benefits with the need to curb abuse and misuse[2].

Market Restraints

Despite the growth potential, the market faces several restraints:

Abuse and Misuse

Hydrocodone bitartrate is associated with high rates of abuse and misuse, which has led to stringent regulatory measures. This has impacted the market negatively, as stricter controls can limit prescription rates and availability[2].

Side Effects and Health Risks

Long-term use of hydrocodone bitartrate can lead to chronic dependency, liver damage, mental health issues, and other adverse effects. These risks can deter some patients and healthcare providers from using the drug[5].

Regulatory Challenges

Regional and national regulations, such as the emergency declaration in Massachusetts banning hydrocodone-only extended-release products, can create market challenges. These regulations often aim to mitigate the risks associated with opioid use[3].

Market Opportunities

The market presents several opportunities for growth and innovation:

Extended-Release Formulations

The development of extended-release formulations like Zohydro™ ER offers a significant opportunity. These products provide better long-term pain control and reduce the risk of abuse by maintaining consistent blood levels[3].

Abuse-Deterrent Technologies

The integration of abuse-deterrent technologies into hydrocodone bitartrate products can help mitigate the risk of misuse and improve the overall safety profile of the drug[3].

Emerging Markets

Expanding into emerging markets, particularly in the Asia-Pacific region, can provide new avenues for growth. Increasing healthcare spending and a growing need for pain management solutions in these regions present lucrative opportunities[1].

Financial Trajectory

The financial trajectory of the hydrocodone bitartrate market is promising, with several key indicators:

Revenue Growth

The market is expected to see significant revenue growth, measured in USD million, across various segments. The forecast period from 2024 to 2031 is anticipated to be particularly robust[1][4].

Competitor Analysis

Key players such as Johnson Matthey, Noramco, and Sun Pharma are significant contributors to the market. The competitive landscape is dynamic, with companies focusing on product innovation, regulatory compliance, and market expansion[1].

Regional Analysis

North America, driven by the U.S. market, will continue to dominate the global hydrocodone bitartrate market. However, other regions, especially the Asia-Pacific, are expected to show substantial growth due to increasing healthcare demands and economic development[1].

Consumer Behavior and Economic Impact

Consumer behavior plays a crucial role in shaping the market:

Patient Needs

Patients seeking effective pain management solutions drive the demand for hydrocodone bitartrate. The availability of different formulations caters to various patient needs, influencing market dynamics[3].

Economic Factors

The economic impact of hydrocodone bitartrate use is significant. Financial issues associated with long-term use, such as job loss and healthcare costs, can affect both individuals and the broader economy[5].

Regulatory Landscape

The regulatory environment is a critical factor in the hydrocodone bitartrate market:

FDA Regulations

The FDA's rescheduling of hydrocodone and limits on acetaminophen content have significantly impacted the market. These regulations aim to balance medical benefits with safety concerns[2].

Regional Regulations

Regional regulations, such as those in Massachusetts, can restrict the use of certain hydrocodone products, affecting market dynamics and growth prospects[3].

Technological Trends and Innovations

Technological advancements are crucial for the future of the hydrocodone bitartrate market:

Abuse-Deterrent Formulations

The development of abuse-deterrent formulations is a key trend. These technologies help reduce the risk of misuse and improve the safety profile of the drug[3].

Extended-Release Technologies

Extended-release formulations are becoming more prevalent, offering better long-term pain control and reduced risk of abuse[3].

Key Takeaways

  • The hydrocodone bitartrate market is expected to experience significant growth from 2023 to 2031.
  • The market is segmented by type, application, and geographical region.
  • Extended-release formulations and abuse-deterrent technologies are key drivers of market growth.
  • Regulatory changes and regional regulations play a crucial role in shaping market dynamics.
  • Consumer behavior and economic factors significantly influence the market.

Frequently Asked Questions (FAQs)

1. What is the primary driver of the hydrocodone bitartrate market? The primary driver is the increasing demand for effective pain management solutions, particularly for chronic pain conditions.

2. Which region dominates the global hydrocodone bitartrate market? North America, particularly the U.S., dominates the global market, accounting for 99% of the global supply.

3. What are the main types of hydrocodone bitartrate products? The main types include hydrocodone bitartrate capsules, extended-release tablets, and oral solutions.

4. How have regulatory changes impacted the hydrocodone bitartrate market? Regulatory changes, such as the FDA's rescheduling of hydrocodone and limits on acetaminophen content, have balanced medical benefits with safety concerns, influencing market dynamics.

5. What are the potential long-term effects of hydrocodone bitartrate use? Long-term effects include chronic dependency, liver damage, mental health issues, tolerance, and financial issues.

Cited Sources:

  1. Market Research Intellect. Hydrocodone Bitartrate Market Size, Scope And Forecast Report.
  2. PubMed. Hydrocodone bitartrate for chronic pain.
  3. U.S. District Court for the District of Massachusetts. Case 1:14-cv-11689-RWZ Document 1 Filed 04/07/14.
  4. Cognitive Market Research. Global Hydrocodone Bitartrate Market Report 2024 Edition.
  5. Spokane Falls Recovery Center. Is Vicodin Addictive? Long-Term and Short-Term Effects.

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