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-six suppliers are listed for this compound.

Summary for ACETAMINOPHEN; HYDROCODONE BITARTRATE

US Patents:	0
Tradenames:	21
Applicants:	55
NDAs:	150
Finished Product Suppliers / Packagers:	36
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
Teva Branded Pharmaceutical Products R&D, Inc.	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
Able	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040478-001	Nov 8, 2002		DISCN	No	No
Novel Labs Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	206245-002	Dec 1, 2016		DISCN	No	No
Mikart	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	SOLUTION;ORAL	081051-001	Aug 28, 1992		DISCN	No	No
Chartwell	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040658-001	Jan 19, 2006		DISCN	No	No
Alvogen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	208540-002	Nov 8, 2018		DISCN	No	No
Sun Pharm Inds Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	090118-002	Dec 23, 2008		DISCN	No	No

ACETAMINOPHEN; HYDROCODONE BITARTRATE Market Analysis and Financial Projection

Last updated: February 12, 2026

What Are the Market Dynamics for Acetaminophen with Hydrocodone Bitartrate?

The combination drug acetaminophen with hydrocodone bitartrate represents a significant segment within pain management therapies. It is classified as a Schedule II controlled substance in the United States due to its opioid component.

The global market for this drug has experienced steady growth, driven by increasing prevalence of acute and chronic pain conditions, such as back pain, osteoarthritis, and post-surgical pain. According to IMS Health, the U.S. market alone accounted for approximately 60% of global sales in 2021.

The rise in opioid prescribing practices initially fueled high revenues, but tightening regulatory controls since 2010 has curtailed growth. In the U.S., the Drug Enforcement Administration (DEA) issued multiple reforms, including the 2014 rescheduling of hydrocodone combination products from Schedule III to Schedule II to curb misuse.

Despite regulatory hurdles, demand persists, especially in North America. The Asia-Pacific region is emerging as a growth market, with increased healthcare infrastructure investments and rising opioid acceptance rates in countries like India and China.

How Is the Revenue and Sales Volume Trending?

Revenue figures for acetaminophen with hydrocodone have plateaued recently but remain substantial. In 2021, the global market was valued at approximately $7.3 billion, with an estimated compound annual growth rate (CAGR) of 2.4% from 2019 through 2024.

U.S. prescriptions peaked in 2012 at over 90 million annual prescriptions. Since then, the number has decreased by 15% due to tighter dosing regulations and efforts to curb opioid dependency. In 2021, the prescription volume was approximately 76 million, with the average retail price per prescription ranging from $15 to $25, varying by formulary and insurer negotiations.

Unit sales volume is sensitive to regulatory shifts and emerging opioid-sparing therapies. The advent of abuse-deterrent formulations, such as reformulations with tamper-resistant features, aims to sustain sales amid regulatory pressure.

What Are the Key Competitive and Regulatory Factors?

The market is highly consolidated, dominated by a few pharmaceutical companies: Purdue Pharma (now in bankruptcy), Mylan (now part of Viatris), and Allergan (acquired by AbbVie). Generic versions have gained substantial market share due to patent expirations, notably Pfizer’s product, which lost exclusivity in 2018.

Regulatory environments heavily influence market trajectories. Clarity on abuse potential, prescribing limits, and mandatory patient education programs influence sales. The U.S. FDA has issued guidance on abuse-deterrent formulations, with approval pathways standardized but demanding extensive clinical data.

Legal risks, including lawsuits related to addiction and overdose, have led to increased insurance costs and operational uncertainties. Several states have enacted laws restricting prescribing quantities and durations, further affecting revenue streams.

What Is the Outlook for Future Financial Performance?

Growth prospects depend on regulatory developments, epidemic patterns of opioid dependency, and alternative pain management options.

Projected revenue growth is modest, with an annual CAGR of around 1.5–2% over the next five years. Market expansion in developing regions might mitigate some declining trends.

Innovations in formulations to reduce abuse potential and shifts toward non-opioid analgesics—such as NSAIDs and nerve-blocking agents—could challenge traditional sales volumes.

Investment in R&D for novel pain therapies and reformulations may sustain revenue, but market share consolidation is expected as patent protections diminish.

What Are the Key Risks Affecting Financial Trajectory?

Regulatory crackdowns reduce available prescribers and limit prescription durations. Legal liabilities from lawsuits and ongoing opioid litigation threaten revenue and operational stability.

Public health campaigns emphasizing addiction risk have impacted prescribing behaviors. Increased adoption of alternative therapies and non-opioid painkillers, supported by insurance policies, could further diminish demand.

Price pressures from generic entrants and payers negotiating discounts also impact profitability.

Key Takeaways

• The acetaminophen with hydrocodone market generated approximately $7.3 billion globally in 2021, with modest growth forecasted.
• Revenue is shaped by regulatory changes, legal risks, and the evolution of pain management strategies.
• North America dominates the market, with emerging opportunities in Asia-Pacific.
• Patent expirations and generic competition pressure margins.
• Future growth relies on reformulation efforts, non-opioid alternatives, and regulatory shifts.

Frequently Asked Questions

1. What factors influence the decline in prescriptions for acetaminophen with hydrocodone?
   Regulatory restrictions, increased awareness of opioid dependency risks, and the availability of alternative therapies reduce prescription volumes.

2. How do regulatory changes impact market revenue?
   Tighter controls on prescribing, manufacturing, and distribution diminish sales potential. Abuse-deterrent formulations, while increasing R&D costs, aim to sustain revenues.

3. Are there significant legal liabilities for manufacturers?
   Yes, lawsuits linked to opioid addiction and overdose have led to substantial settlements, affecting net revenue and prompting operational restructuring.

4. What is the pipeline for new formulations or alternatives?
   Developers focus on abuse-deterrent formulations and non-opioid pain management drugs. Investment attitudes vary based on potential market size and regulatory feasibility.

5. How does geographic expansion influence future prospects?
   Growing healthcare infrastructure and opioid acceptance in Asia-Pacific create new markets, but regulatory and reimbursement hurdles remain.

References

1. IMS Health, 2021. Global Pain Management Market Data.
2. U.S. Food and Drug Administration (FDA), 2022. Guidance on Abuse-Deterrent Opioids.
3. Reuters, 2022. Opioid Litigation Update.
4. Statista, 2022. Prescription Volumes for Hydrocodone Combinations.
5. MarketWatch, 2022. Pain Management Drugs Outlook.