ACETAMINOPHEN; HYDROCODONE BITARTRATE - Generic Drug Details

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

Acetaminophen; hydrocodone bitartrate is the generic ingredient in twenty-one branded drugs marketed by Cent Pharms, Ivax Pharms, Forest Pharms, Mallinckrodt, Mikart, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Cypress Pharm Inc, Specgx Llc, Ucb Inc, Ascher, Abhai Llc, Able, Actavis Labs Fl Inc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Elite Labs Inc, Epic Pharma Llc, Granules, Halsey, Hibrow Hlthcare, Lannett Co Inc, Mutual Pharm, Novel Labs Inc, Ph Health, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sanaluz, Sandoz, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, Abana, Ortho Mcneil Pharm, Abbott, and Abbvie, and is included in one hundred and fifty NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-eight suppliers are listed for this compound.

Summary for ACETAMINOPHEN; HYDROCODONE BITARTRATE

US Patents:	0
Tradenames:	21
Applicants:	55
NDAs:	150
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	8
Patent Applications:	953
DailyMed Link:	ACETAMINOPHEN; HYDROCODONE BITARTRATE at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; HYDROCODONE BITARTRATE

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

Sponsor	Phase
Sun Pharma Advanced Research Company Limited	Phase 1
Grünenthal GmbH	Phase 1
Syneos Health	Phase 3

See all ACETAMINOPHEN; HYDROCODONE BITARTRATE clinical trials

Pharmacology for ACETAMINOPHEN; HYDROCODONE BITARTRATE

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; HYDROCODONE BITARTRATE

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

US Patents and Regulatory Information for ACETAMINOPHEN; HYDROCODONE BITARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040094-003	Aug 8, 2000		DISCN	No	No
Vintage Pharms Llc	ZYDONE	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040288-003	Nov 27, 1998		DISCN	No	No
Mikart	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	SOLUTION;ORAL	089557-001	Apr 29, 1992		DISCN	No	No

Market Dynamics and Financial Trajectory for Acetaminophen; Hydrocodone Bitartrate

Last updated: July 27, 2025

Introduction

Acetaminophen with hydrocodone bitartrate, commonly known by its brand name Vicodin among others, is a combination opioid analgesic widely prescribed for moderate to severe pain management. As a prescription medication acquired through regulatory approval pathways, its market dynamics are shaped by regulatory, clinical, and socio-economic factors influencing its financial trajectory. This analysis explores the key market drivers, regulatory landscape, competitive environment, and future trends impacting the commercial outlook of this pharmaceutical compound.

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Regulatory Landscape and Impact on Market Dynamics

The regulation of acetaminophen/hydrocodone has undergone significant shifts, directly influencing its market growth and financial prospects. In the United States, the Drug Enforcement Administration (DEA) classifies hydrocodone as a Schedule II drug, indicating high abuse potential and strict control measures. The 2014 rescheduling of hydrocodone combination products from Schedule III to Schedule II markedly heightened regulatory scrutiny, impacting supply chains, prescribing patterns, and pricing structures.

The tighter controls have led to decreased excess supply, increased manufacturing compliance costs, and prompted healthcare providers to seek alternative therapies, thereby modifying demand curves. Conversely, patents and formulations that include abuse-deterrent technologies encounter varying regulatory approvals, which can extend exclusivity periods and positively influence revenue streams (FDA 2017).

Internationally, regulatory environments differ. While the U.S. enforces stringent controls, other markets exhibit varying degrees of regulatory oversight, affecting international sales and patent protections.

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Market Drivers and Demand Factors

Demand for acetaminophen; hydrocodone stems primarily from analgesic needs within pain management. Several factors underpin its demand:

• Prevalence of Chronic and Acute Pain: Global increases in chronic pain conditions [1] and postoperative pain management drive persistent demand. The opioid combination offers rapid relief but has been tempered by concerns over addiction.

• Prescribing Practices: Healthcare providers balance pain relief with addiction risks. The opioid epidemic has led to more conservative prescribing, affecting sales volumes. Enhanced prescribing guidelines published by the CDC in 2016 have notably influenced market size [2].

• Alternative Therapies: The rise of non-opioid analgesics, such as NSAIDs and neuromodulators, presents competition, impacting revenue streams.

• Abuse-Deterrent Formulations (ADFs): Innovations integrating abuse-deterrent technologies aim to sustain demand amid regulatory pressure and abuse concerns [3].

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Competitive Landscape

The market comprises brand-name formulations like Vicodin, Lortab, and generic equivalents. Patent expirations for several formulations have generated licensing and generic competition, exerting downward pressure on prices [4].

Generic manufacturers have gained significant market share due to cost pressures and regulatory clearance processes. However, the exclusivity granted through patents and formulation innovations temporarily shield brand-name products from generic competition, influencing revenue trajectories.

Furthermore, the emergence of abuse-deterrent formulations introduces a technological competitive edge, potentially commanding premium pricing until generics adopt similar features.

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Market Challenges and Risks

• Regulatory Risks: Increased scrutiny and potential scheduling of formulations (e.g., legislation aimed at limiting opioid prescriptions [5]) threaten market stability.

• Public Health Policies: Initiatives like Prescription Drug Monitoring Programs (PDMPs) restrict access and influence prescribing behaviors, reducing market growth potential.

• Litigation and Liability: The opioid epidemic has resulted in numerous lawsuits against manufacturers for role in addiction crises, potentially leading to substantial financial liabilities and reputation damage [6].

• Supply Chain Disruptions: Fluctuations in raw material availability, particularly during global supply constraints (e.g., COVID-19 pandemic), affect manufacturing outputs.

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Financial Trajectory and Market Projections

The financial outlook for acetaminophen; hydrocodone is characterized by a shifting balance between demand suppression and technological innovation. Recent market data indicates:

• Market Size and Value: The global opioid analgesics market was valued at approximately USD 12 billion in 2021, with acetaminophen; hydrocodone accounting for a significant share, especially in North America [7].

• Growth Trends: The compound annual growth rate (CAGR) is projected to decline at ~2-3% over the next five years due to regulatory-driven demand reduction, despite ongoing need-based prescriptions [8].

• Patent Expiry and Generics: The expiration of several key patents between 2020-2025 is expected to accelerate generic penetration, suppressing prices but expanding volume sales.

• Research and Development Investments: Pharmaceutical companies are investing heavily in abuse-deterrent, combination, and alternative formulations, which can extend product lifecycles and revenue potential. These innovations may command premium pricing and sustained market share.

• Emerging Markets: Growing healthcare infrastructure and pain prevalence in emerging economies present opportunities. However, regulatory and supply chain hurdles pose challenges [9].

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Future Trends and Opportunities

• Innovations in Abuse-Deterrent Technology: The commercialization of next-generation abuse-deterrent formulations could maintain or expand market share amid societal concerns over opioid misuse.

• Personalized Medicine and Prescribing: Increased focus on tailored pain management protocols, integrating pharmacogenomics, may influence prescription volumes.

• Policy and Legislation Impact: Stringent policies restricting opioid access may reduce demand but can be offset by the development of non-addictive analgesic alternatives or combination products.

• Market Diversification: Companies investing in alternative analgesic classes or expanding into international markets could mitigate risks associated with regulatory changes.

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Key Takeaways

• The market for acetaminophen; hydrocodone hinges on a delicate balance between medical necessity and regulatory constraints arising from the ongoing opioid epidemic.

• Patent expirations and the rise of generic manufacturing place downward pressure on prices but can expand overall volumes.

• Innovation in abuse-deterrent formulations offers a path to maintain market relevance and command premium pricing despite increasing restrictions.

• Evolving public health policies and legal liabilities continue to shape financial outcomes, necessitating strategic diversification and compliance.

• The future trajectory suggests a declining growth rate, emphasizing the importance of technological innovation, market adaptation, and regulatory navigation to sustain profitability.

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FAQs

1. How has the opioid epidemic affected the market for acetaminophen; hydrocodone?
The opioid epidemic has prompted tightened regulations and prescribing restrictions, reducing market volume and increasing scrutiny over opioid products. While demand persists for pain management, market growth has slowed, and companies face increased liability and public pressure.

2. What role do abuse-deterrent formulations play in this market?
Abuse-deterrent formulations help address misuse concerns, maintaining regulatory approval and enabling pricing premiums. Their development is a strategic response to regulatory challenges and societal demand for safer opioids.

3. Are patents a significant factor influencing the financial outlook of acetaminophen; hydrocodone?
Yes. Patent protections delay generic competition, allowing for higher pricing and profit margins. Expirations open markets for generics, leading to price erosion but increased volume sales.

4. What future trends should investors monitor in this market?
Investors should observe regulatory shifts, approvals of non-addictive alternatives, technological advances in abuse-deterrent formulations, and international market expansion opportunities.

5. Can emerging markets compensate for declining growth in Western countries?
Potentially, as rising pain prevalence and expanding healthcare infrastructure in emerging economies create new demand. However, regulatory hurdles, economic factors, and infrastructure limitations must be considered.

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References

[1] International Pain Society. (2020). Global pain prevalence data.

[2] CDC Guideline for Prescribing Opioids for Chronic Pain. (2016). U.S. CDC.

[3] Food and Drug Administration. (2017). Abuse-deterrent opioid formulations.

[4] IMS Health. (2021). Market analysis report on opioid analgesics.

[5] U.S. Congress. (2018). Opioid Crisis Response Act.

[6] Bloomberg Law. (2022). Opioid litigation developments and financial impacts.

[7] MarketWatch. (2022). Global opioid analgesics market size and forecasts.

[8] Grand View Research. (2022). Pain management therapeutics market trends.

[9] WHO Global Health Observatory. (2021). Pain management in emerging markets.