Hydrocodone bitartrate; ibuprofen - Generic Drug Details

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

Hydrocodone bitartrate; ibuprofen is the generic ingredient in four branded drugs marketed by Strides Pharma, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, and Abbvie, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for hydrocodone bitartrate; ibuprofen

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
DailyMed Link:	hydrocodone bitartrate; ibuprofen at DailyMed

Recent Clinical Trials for hydrocodone bitartrate; ibuprofen

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

Sponsor	Phase
Cephalon	Phase 1

See all hydrocodone bitartrate; ibuprofen clinical trials

Pharmacology for hydrocodone bitartrate; ibuprofen

Drug Class	Nonsteroidal Anti-inflammatory Drug Opioid Agonist
Mechanism of Action	Cyclooxygenase Inhibitors Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for hydrocodone bitartrate; ibuprofen

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

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; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	10 mg/200 mg	020716	1	2006-03-20
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	2.5 mg/200 mg	020716	1	2006-02-24

US Patents and Regulatory Information for hydrocodone bitartrate; ibuprofen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	091633-002	May 28, 2013		DISCN	No	No
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-002	Mar 18, 2004		RX	No	No
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-001	Oct 12, 2004	AB	RX	No	Yes
Amneal Pharms Ny	REPREXAIN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-004	Oct 19, 2007		DISCN	No	No
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997		DISCN	Yes	No
Sun Pharm Inds Inc	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	091633-003	May 28, 2013		DISCN	No	No

Expired US Patents for hydrocodone bitartrate; ibuprofen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997

Market Dynamics and Financial Trajectory for Hydrocodone Bitartrate and Ibuprofen

Last updated: July 30, 2025

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Introduction

Hydrocodone Bitartrate and Ibuprofen represent significant segments within the global analgesic market, each serving distinct yet occasionally overlapping therapeutic roles. As prescription and over-the-counter (OTC) analgesics, their market dynamics are shaped by regulatory landscapes, evolving consumer preferences, technological advances, and broader healthcare trends. This article examines the current market environment, forecasted trajectories, and strategic considerations pertinent to stakeholders.

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Pharmacological Overview and Market Segments

Hydrocodone Bitartrate is an opioid analgesic primarily prescribed for moderate to severe pain and cough suppression. It falls under controlled substances due to potential misuse and dependency risks. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is widely used OTC for mild to moderate pain, inflammation, and fever reduction.

The differentiation in regulation and usage profiles significantly impacts their respective market dynamics. Hydrocodone Bitartrate’s market is tightly controlled, with prescribing patterns influenced by opioid regulations, while Ibuprofen’s OTC status fosters broader access and consumption.

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Market Dynamics

Regulatory Environment and Legislative Trends

The opioid epidemic has precipitated rigorous regulatory reforms globally. In the United States, the DEA’s reclassification of hydrocodone combination products from Schedule III to Schedule II in 2014 and subsequent prescription monitoring programs have curtailed overprescription, directly affecting market volume [1]. Similar tightening regulations in Europe and Asia have contributed to a decline or stabilization in hydrocodone sales.

Conversely, regulations around OTC NSAIDs like Ibuprofen remain relatively permissive, although concerns around gastrointestinal, renal, and cardiovascular adverse effects have prompted more stringent warnings and recommended dosing limits, influencing consumer use patterns.

Epidemiological Factors and Healthcare Access

The aging population globally increases demand for pain management solutions, especially for chronic conditions such as osteoarthritis and back pain, which historically expand markets for both hydrocodone and Ibuprofen [2]. However, rising awareness of opioid dependency risks shifts prescribing toward multimodal pain management and non-opioid alternatives, influencing hydrocodone's market trajectory.

Technological Innovation and Formulations

Advancements include abuse-deterrent formulations (ADFs) for hydrocodone, aiming to reduce misuse potential [3]. These innovations increase production costs but may enable sustained market relevance amid regulatory scrutiny.

For Ibuprofen, novel delivery systems—such as fast-dissolving formulations, combination products with other analgesics, and targeted topical applications—enhance patient compliance and expand therapeutic claims [4].

Market Competition and Alternatives

The market faces stiff competition from other opioids (e.g., oxycodone, morphine) and NSAIDs (e.g., naproxen, aspirin), along with non-pharmacological interventions like physical therapy and neuromodulation. The shift toward non-opioid, non-NSAID analgesics, and cannabinoids is noteworthy, driven by safety profiles and consumer preferences.

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Market Size and Financial Trajectory

Hydrocodone Bitartrate Market Outlook

Pre-pandemic estimates placed the global hydrocodone market at approximately USD 3.2 billion in 2019, with the North American region dominating due to higher prescribing rates [5]. Post-pandemic, the market experienced an initial decline owing to regulatory constraints, with a gradual stabilization expected as regulatory environments adapt and new formulations are introduced.

Growth forecasts suggest a compound annual growth rate (CAGR) of approximately 2-3% through 2028, primarily driven by unmet medical needs in pain management, especially for patients with opioid use disorder (OUD) treatments and abuse-deterrent products. Nonetheless, the market's upside is limited by regulatory risks and societal efforts to minimize opioid dependence.

Ibuprofen Market Outlook

The global OTC ibuprofen market was valued at around USD 4.5 billion in 2020, exhibiting resilience despite the pandemic’s disruption [6]. Its widespread availability and benign safety profile underpin a relatively steady growth, with a projected CAGR of approximately 4-5% over the next decade.

Emerging markets in Asia and Latin America contribute significantly to expansion, bolstered by increasing healthcare expenditure, urbanization, and consumer health awareness. Moreover, innovations in delivery and combination therapies are expected to further augment market size.

Financial Trajectory Summary

Market Segment	2023 Estimate	2028 Projection	CAGR (2023-2028)	Key Drivers
Hydrocodone Bitartrate	USD 3.4 billion	USD 3.8 billion	2-3%	Regulatory stabilization, abuse-deterrent formulations, OUD treatment needs
Ibuprofen	USD 4.8 billion	USD 6.0 billion	4-5%	OTC demand, emerging markets, formulation innovation

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Strategic Considerations

Regulatory Compliance and Market Access

Producers must navigate evolving legislation, including prescription controls and safety warnings. Quality assurance in formulations, especially abuse-deterrent hydrocodone products, remains critical.

Innovation and Differentiation

Investment in alternative delivery systems, combination therapies, and abuse-mitigating technologies can differentiate products and tap into unmet needs, especially as opioid markets contract.

Market Penetration in Emerging Economies

Expanding accessible and affordable formulations in emerging markets offers growth opportunities, considering increasing healthcare infrastructure and consumer awareness.

Addressing Public Health Concerns

Balancing profit with responsibility necessitates engagement with policymakers, healthcare providers, and consumers to foster safe usage and mitigate abuse risks.

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Key Takeaways

• Regulatory landscapes heavily influence hydrocodone's market size, with tightening controls dampening growth prospects; innovation in abuse deterrence is vital for market relevance.

• Ibuprofen benefits from widespread OTC availability, with robust growth driven by population aging, emerging economies, and drug formulation advancements.

• Integrating non-opioid alternatives and multimodal pain therapies will shape future market dynamics, especially amidst societal efforts to combat opioid misuse.

• Innovation in drug delivery and safety features remains central to maintaining competitiveness and market share within both segments.

• Market stakeholders should capitalize on emerging markets and focus on regulatory compliance and product differentiation to sustain long-term growth.

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FAQs

1. How will the ongoing opioid crisis impact the future of hydrocodone Bitartrate?
The opioid crisis has led to stricter prescribing regulations and enhanced scrutiny over hydrocodone products. While this suppresses growth prospects, it also incentivizes the development of abuse-deterrent formulations and alternative therapies, maintaining market relevance but at a potentially reduced volume.

2. What technological innovations are influencing the Ibuprofen market?
Advances include targeted delivery systems such as topical gels, fast-dissolving tablets, and combination formulations that improve efficacy and safety, expanding its therapeutic utility and consumer appeal.

3. Are there emerging legal or policy developments that could significantly alter these markets?
Yes. Regulatory reforms aimed at curbing opioid abuse are likely to persist, influencing hydrocodone’s market. Simultaneously, policies promoting OTC access and safety education could further bolster Ibuprofen sales.

4. How do safety concerns affect the competitive landscape for both drugs?
Safety profiles shape regulation and consumer perception. Hydrocodone’s dependence risks lead to tighter controls, while gastrointestinal and cardiovascular risks with Ibuprofen prompt warnings and dosing guidelines—both factors influencing market positioning.

5. What role do healthcare provider prescribing behaviors play in shaping these markets?
Provider discretion drives hydrocodone dispensing volumes, with increasing adoption of multimodal pain management strategies. For Ibuprofen, OTC availability limits prescriber influence but impacts public perception and usage patterns.

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References

[1] Substance Abuse and Mental Health Services Administration. "Opioid Policy Database," 2021.
[2] World Health Organization. "Global status report on noncommunicable diseases," 2014.
[3] U.S. Food & Drug Administration. "Abuse-deterrent opioids," 2019.
[4] European Medicines Agency. "Ibuprofen safety and efficacy," 2020.
[5] MarketWatch. "Hydrocodone Market Size, Share & Trends," 2021.
[6] Grand View Research. "OTC NSAID Market Analysis," 2021.