HYDROCODONE BITARTRATE - Generic Drug Details

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

Hydrocodone bitartrate is the generic ingredient in eleven branded drugs marketed by Alvogen, Recro Gainesville, Purdue Pharma Lp, Teva Branded Pharm, Nostrum Labs Inc, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, Abbvie, Alpharma Us Pharms, Mayne Pharma Inc, Padagis Us, Sciegen Pharms Inc, Tris Pharma Inc, and Persion, and is included in nineteen NDAs. There are thirty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydrocodone bitartrate has three hundred and eighty-two patent family members in forty-nine countries.

There are sixteen drug master file entries for hydrocodone bitartrate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for HYDROCODONE BITARTRATE

International Patents:	382
US Patents:	39
Tradenames:	11
Applicants:	18
NDAs:	19
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	30
Patent Applications:	457
Drug Prices:	Drug price trends for HYDROCODONE BITARTRATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYDROCODONE BITARTRATE
What excipients (inactive ingredients) are in HYDROCODONE BITARTRATE?	HYDROCODONE BITARTRATE excipients list
DailyMed Link:	HYDROCODONE BITARTRATE at DailyMed

See drug prices for HYDROCODONE BITARTRATE

Recent Clinical Trials for HYDROCODONE BITARTRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Elysium Therapeutics, Inc.	Phase 1
Medpace, Inc.	Phase 1
Ohio Third Frontier	Phase 1

See all HYDROCODONE BITARTRATE clinical trials

Generic filers with tentative approvals for HYDROCODONE BITARTRATE

Applicant	Application No.	Strength	Dosage Form
		40MG	CAPSULE, EXTENDED RELEASE;ORAL
		10MG	CAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for HYDROCODONE BITARTRATE

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Medical Subject Heading (MeSH) Categories for HYDROCODONE BITARTRATE

Analgesics, Opioid

Antitussive Agents

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCODONE BITARTRATE

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

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
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	AB	RX	Yes	No
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes			Y
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013		DISCN	Yes	No
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No			Y

Expired US Patents for HYDROCODONE BITARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014

International Patents for HYDROCODONE BITARTRATE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201300747	ТВЕРДАЯ ЛЕКАРСТВЕННАЯ ФОРМА С КОНТРОЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ И СПОСОБЫ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
Eurasian Patent Organization	032906	ТВЕРДАЯ ЛЕКАРСТВЕННАЯ ФОРМА С КОНТРОЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ И СПОСОБЫ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (SOLID CONTROLLED RELEASE DOSAGE FORM AND METHODS OF PREPARATION AND USE THEREOF)
Ecuador	SP13012760	FORMAS DE DOSIS DE LIBERACIÓN CONTROLADA ENCERRADAS RESISTENTES A MANIPULACIONES INDEBIDAS
Australia	2017208386	Encased tamper resistant controlled release dosage forms
Israel	217792	צורות מינון עמידות לשימוש לא מורשה למתן פומי המכילות מאלחש אופיואידי (Tamper resistant oral pharmaceutical dosage forms comprising an opioid analgesic)

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.