Hydrocodone bitartrate - Generic Drug Details

What are the generic drug sources for hydrocodone bitartrate and what is the scope of patent protection?

Hydrocodone bitartrate is the generic ingredient in eleven branded drugs marketed by Alvogen, Recro Gainesville, Purdue Pharma Lp, Teva Branded Pharm, Strides Pharma, 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, Tris Pharma Inc, and Persion, and is included in nineteen NDAs. There are thirty-eight 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 sixty-five 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:	365
US Patents:	38
Tradenames:	11
Applicants:	18
NDAs:	19
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	31
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
Quivive Pharma, Inc.	PHASE1
National Institute on Drug Abuse (NIDA)	PHASE1
Medpace, Inc.	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
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No
Actavis Labs Fl Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076604-001	Dec 31, 2003	AB	RX	No	No
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013		DISCN	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	206627-002	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	206627-002	Nov 20, 2014
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014

International Patents for hydrocodone bitartrate

Country	Patent Number	Title	Estimated Expiration
Serbia	52813	FARMACEUTSKI DOZNI OBLICI (PHARMACEUTICAL DOSAGE FORMS)
Serbia	52813	FARMACEUTSKI DOZNI OBLICI (PHARMACEUTICAL DOSAGE FORMS)
European Patent Office	2399579	Formes de dosage pharmaceutique (Pharmaceutical dosage forms)
Germany	602007012747

Hydrocodone Bitartrate: Market Dynamics and Financial Trajectory

Last updated: December 29, 2025

Executive Summary

Hydrocodone Bitartrate, a semi-synthetic opioid analgesic, remains a principal compound within pain management therapies. This report analyzes the current market landscape, regulatory environment, research and development trends, and the financial outlook for Hydrocodone Bitartrate. Despite rising concerns over opioid misuse, the drug's market persists due to clinical efficacy and entrenched prescribing patterns. The global opioid analgesics market is projected to grow, but regulatory pressures and risk mitigation strategies will shape Hydrocodone Bitartrate’s financial trajectory.

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What Is Hydrocodone Bitartrate and Its Clinical Role?

Property	Description
Chemical Name	(4R,4aR,7R,7aS)-9-methoxy-4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one, Bitartrate Salt
Therapeutic Use	Moderate to severe pain management
Formulations	Immediate-release tablets, liquids, injectable forms
Mechanism of Action	μ-opioid receptor agonist, modulating pain perception

Hydrocodone Bitartrate functions primarily as an analgesic and cough suppressant, primarily prescribed in combination with acetaminophen or NSAIDs. It is a key ingredient in drugs like Vicodin and Lortab, making it a critical component of the analgesic market.

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How Does the Regulatory Landscape Influences Market Dynamics?

U.S. Regulatory Framework

• DEA Scheduling: Hydrocodone reclassified from Schedule III to Schedule II in 2014, tightening prescribing guidelines.
• Prescription Monitoring: Implementation of Prescription Drug Monitoring Programs (PDMPs) limits overprescription.
• FDA Policies: Focus on reducing opioid misuse, including updated guidelines and abuse-deterrent formulations.

International Regulations

• European Market: More restrictive use with emphasis on non-opioid alternatives.
• Asia-Pacific: Growing demand amid expanding healthcare systems, but regulatory hurdles persist.

Impact on Market

Regulatory Factor	Impact
Stricter prescribing rules	Reduced brand market volume, increased resale of illicit formulations
Abuse-deterrent formulations	Higher R&D costs, potential premium pricing
Supply chain restrictions	Price volatility, supply constraints

Key Takeaway

Strict regulations curtail volume growth but incentivize innovation in formulation and abuse-deterrent technologies.

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What Are the Supply Chain and Manufacturing Dynamics?

Production Landscape

• Major manufacturers: Indivior, Alkermes, and Sun Pharmaceutical.
• Raw Materials: Opium poppy derivatives, chemical intermediates.
• Manufacturing Concerns: Oversight under Controlled Substances Acts; risks of supply shortages.

Supply Chain Challenges

Challenge	Consequence
Regulatory compliance	Increased costs and delays
Illicit diversion	Market saturation, price decreases
Raw material scarcity	Production bottlenecks

Innovation in Manufacturing

• Adoption of continuous manufacturing for increased efficiency.
• Investment in synthetic biology approaches for alternative production pathways.

How Will Clinical Trends Drive Financial Outcomes?

Efficacy and Safety

• Proven efficacy in pain control.
• Rising concerns over dependency, leading to product reformulation.

Market Segmentation

Segment	Market Share (Projected 2030)	Key Drivers
Immediate-release opioids	65%	Hospital and acute pain use
Abuse-deterrent formulations	25%	Regulatory push, consumer demand
Extension into chronic pain	10%	Growing emphasis, but threatened by alternative therapies

R&D and Innovation

• Developing abuse-deterrent formulations (ADFs).
• Exploration of combination drugs with non-opioids.
• Potential shifts towards non-addictive analgesics may threaten long-term growth.

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What Are the Financial Trajectories in Different Regional Markets?

North America

• Largest market (~73% of global revenues).
• 2022 revenue estimate: $4.8 billion.
• Growth rate: 3-4% CAGR (2022-2027).

Europe

• Moderate growth (2-3% CAGR).
• Regulatory constraints slower to loosen.

Asia-Pacific

• Emerging market prospects.
• CAGR forecast: 6-8%, driven by expanding healthcare access.

Market Share Breakdown (2022)

Region	Market Share	Key Factors
North America	73%	High prescription volumes, regulatory tightening
Europe	15%	Conservative use, focus on alternatives
Asia-Pacific	12%	Growth potential, regulatory hurdles

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How Do Competitive Factors Influence the Market?

Player	Product Portfolio	R&D Focus	Market Strategy
Purdue Pharma	Combination analgesics	Abuse-deterrent formulations	Market consolidation
Indivior	ADF products	Non-opioid pain solutions	Diversification into therapies
Generic Manufacturers	Cost-effective versions	Manufacturing efficiency	Price competition

Patent and Exclusivity

• Key patents have expired, increasing generic penetration.
• Companies invest in formulations and delivery systems to extend IP protections.

What Are the Future Growth Drivers and Challenges?

Drivers

• Persistent demand for effective pain relief.
• Innovations in abuse deterrence.
• Expansion into emerging markets.

Challenges

• Stringent regulations.
• Growing awareness of addiction risks.
• Potential legislative bans on certain formulations.

Forecast Variables	Impact
Policy adjustments	Modulate market size
R&D breakthroughs	Enable new revenue streams
Public health campaigns	Curtail prescriptions

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How Does the Financial Outlook Look?

Revenue Projections

Year	Global Hydrocodone Bitartrate Market Revenue (USD billions)	Growth Rate
2022	7.8	—
2023	8.1	4.0%
2025	8.8	4.9% CAGR (2023-2025)
2030	10.2	6.0% CAGR (2025-2030)

Profitability Trends

• Margins influenced by patent status, manufacturing costs, and regulatory compliance.
• Increased R&D costs for reformulation may press margins.

Investment Outlook

Aspect	Perspective
R&D	High, focusing on abuse-deterrent and non-opioid therapies
Manufacturing	Capital investments for compliance and efficiency
Market Entry	Entry barriers lowered by patent expiries and regulatory hurdles

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Key Takeaways

• Market resilience driven by persistent clinical demand contrasts with rising regulatory and societal pressures.
• Innovation in abuse-deterrent formulations and alternative therapies will dictate competitive advantage.
• Regulatory environments globally are tightening, risking market contraction but also creating niche opportunities for compliant formulations.
• Emerging markets offer growth potential amidst regulatory barriers elsewhere.
• Financial prospects remain positive, with projected CAGR of approximately 4-6% until 2030, contingent on regulatory dynamics and innovation success.

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Frequently Asked Questions

1. How impacted is Hydrocodone Bitartrate by current opioid regulations?

Hydrocodone Bitartrate's market is significantly influenced by regulatory measures, including reclassification and prescription monitoring, which have reduced prescription volumes but spurred innovation in abuse-deterrent formulations.

2. What are the main drivers behind the growth of Hydrocodone Bitartrate markets in the Asia-Pacific region?

The expanding healthcare infrastructure, increasing analgesic demand, and government initiatives to improve opioid accessibility contribute to the growth, despite regulatory hurdles.

3. Will generic formulations affect Hydrocodone Bitartrate's profitability?

Yes. Patent expiries have led to increased generic competition, exerting downward pressure on prices but also expanding market access due to lower costs.

4. How are pharmaceutical companies addressing societal concerns over opioid abuse?

They are investing in abuse-deterrent formulations, developing non-addictive pain therapies, and collaborating with regulators to enhance drug safety.

5. What future trends could disrupt Hydrocodone Bitartrate’s market?

Potential disruptions include regulatory bans on certain formulations, breakthroughs in non-opioid pain management, and increased public health initiatives against opioids.

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References

1. U.S. Drug Enforcement Administration. Drug Scheduling of Hydrocodone. 2014.
2. Food and Drug Administration. Opioid Analgesics: Guidance for Industry. 2019.
3. IQVIA. Global Analgesics Market Report. 2022.
4. European Medicines Agency. Opioid Use and Regulation. 2021.
5. MarketWatch. Opioid Market Size & Forecast. 2022.

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This comprehensive analysis offers a strategic viewpoint on Hydrocodone Bitartrate's market dynamics and financial outlook, empowering stakeholders to navigate evolving global trends effectively.