When do the patents on ACETAMINOPHEN AND HYDROCODONE BITARTRATE expire, and when will ACETAMINOPHEN AND HYDROCODONE BITARTRATE go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cent Pharms	ACETAMINOPHEN AND HYDROCODONE BITARTRATE	acetaminophen; hydrocodone bitartrate	CAPSULE;ORAL	088898-001	Mar 27, 1985		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: October 1, 2026

Acetaminophen and hydrocodone bitartrate is a mature, predominantly generic opioid combination. Its commercial value has shifted from branded products such as Vicodin, Norco, and Lortab to low-margin generic tablets and, to a lesser extent, oral solutions and capsules. The product has no meaningful remaining pioneer-drug exclusivity, limited current patent protection, and high regulatory exposure because hydrocodone is a Schedule II controlled substance.

The market faces structural contraction from opioid-prescribing limits, abuse-deterrence policies, state restrictions, payer controls, and competition from non-opioid pain treatments. Revenue opportunities remain in reliable supply, hospital and institutional contracts, manufacturing efficiency, and product formats that meet prescribing and safety requirements.

What is the FDA regulatory status of acetaminophen and hydrocodone bitartrate?

Acetaminophen and hydrocodone bitartrate products are FDA-approved prescription combination analgesics. Hydrocodone is the opioid component; acetaminophen provides non-opioid analgesic activity.

Most immediate-release products contain one of the following strengths:

Hydrocodone bitartrate	Acetaminophen	Common dosage form
2.5 mg	325 mg	Tablet
5 mg	300 mg or 325 mg	Tablet, capsule, solution
7.5 mg	300 mg or 325 mg	Tablet, solution
10 mg	300 mg or 325 mg	Tablet, solution

FDA required manufacturers to limit prescription combination products to no more than 325 mg of acetaminophen per dosage unit because of liver-injury risk. The agency also requested withdrawal of products containing more than 325 mg of acetaminophen per unit in 2014 (U.S. Food and Drug Administration [FDA], 2014).

Hydrocodone combination products were moved from Schedule III to Schedule II under the Controlled Substances Act in 2014. The change increased prescribing controls, eliminated refills, and raised administrative burdens for prescribers, pharmacies, distributors, and manufacturers (Drug Enforcement Administration [DEA], 2014).

When does acetaminophen-hydrocodone lose exclusivity?

The pioneer exclusivity period for the principal branded combination products expired decades ago. Current sales are primarily generic and do not depend on new chemical entity exclusivity.

Product or product family	Commercial status	Exclusivity position
Vicodin	Brand legacy product; generic substitution dominates	Pioneer exclusivity expired
Norco	Brand and authorized-generic legacy products	Pioneer exclusivity expired
Lortab	Brand legacy product; discontinued or commercially limited in many channels	Pioneer exclusivity expired
Generic hydrocodone/acetaminophen tablets	Active market	ANDA-based competition
Generic oral solutions and capsules	Smaller market segments	ANDA-based competition

The active pharmaceutical ingredients are old, and the combination has been marketed for many years. The principal commercial barrier is therefore not basic composition-of-matter protection. It is regulatory compliance, controlled-substance supply authorization, manufacturing capacity, quality systems, and channel access.

What patents protect acetaminophen and hydrocodone bitartrate?

No broadly meaningful, current composition-of-matter patent protects the conventional immediate-release acetaminophen and hydrocodone bitartrate combination. The core combination is an established product with extensive generic approval history.

Formulation patents

Potentially relevant patents could cover:

Extended-release hydrocodone delivery systems
Abuse-deterrent tablets
Modified-release matrices
Taste-masked oral solutions
Specific particle sizes or manufacturing processes
Combination products with additional active ingredients

Those protections generally apply to a defined formulation or delivery system rather than to conventional immediate-release hydrocodone/acetaminophen tablets. A manufacturer seeking to launch a standard immediate-release generic normally competes through an ANDA rather than developing a novel formulation protected by a new patent estate.

Method-of-use patents

Method-of-use patents are not a major current barrier for standard hydrocodone/acetaminophen products. The primary use, short-term treatment of moderate to moderately severe pain, is an established indication. Any remaining method claims would need to be evaluated against the specific product labeling, patent listing, and proposed generic label.

Orange Book status

The FDA Orange Book is the controlling public source for listed patents and exclusivity associated with approved drug products. For conventional acetaminophen-hydrocodone products, commercial competition is primarily generic rather than patent-driven. Legacy patents associated with branded products do not create a current market-wide barrier when they have expired, been delisted, or no longer cover the proposed generic product.

Orange Book analysis must be performed at the NDA and formulation level because Vicodin, Norco, Lortab, and later hydrocodone combination products have separate approval histories and may not share identical labeling or patent records (FDA, 2024a).

How many patents cover generic hydrocodone and acetaminophen?

There is no single patent count for the entire product category. The relevant number depends on:

The reference-listed drug.
The dosage form and strength.
The proposed generic formulation.
The jurisdiction.
Whether formulation, manufacturing, or method-of-use patents are included.
Whether expired or delisted patents are counted.

For conventional immediate-release tablets, the commercially relevant patent burden is low. Patent risk can be higher for modified-release products, abuse-deterrent products, or specialized delivery systems.

The key distinction is between:

Category-level protection, which is weak or absent for standard immediate-release products.
Product-specific protection, which can exist for a particular formulation, label, or manufacturing process.
Operational barriers, including DEA quotas and controlled-substance compliance, which are not patent rights but can delay or prevent launch.

Which companies manufacture acetaminophen and hydrocodone bitartrate?

The U.S. market has included a broad group of generic manufacturers and contract manufacturers. Participants have included companies such as Amneal Pharmaceuticals, Hikma Pharmaceuticals, Mallinckrodt, Rhodes Pharmaceuticals, Teva Pharmaceutical Industries, Endo Pharmaceuticals, and other FDA-approved ANDA holders. Product availability changes by strength, NDC, manufacturing site, supply agreement, and distributor inventory.

Brand ownership is less important than ANDA ownership and active commercial supply. A company may retain an approved ANDA but have limited or no current commercial distribution. The practical competitive set is therefore narrower than the full list of historical approvals.

Manufacturing and supply barriers

Manufacturers face several constraints:

DEA production quotas for hydrocodone.
Quota allocation across multiple hydrocodone products.
Controlled-substance registration for manufacturing and distribution sites.
Serialization and chain-of-custody requirements.
Audit and diversion-control obligations.
Acetaminophen content uniformity and impurity control.
Shortage risk from plant shutdowns, remediation, or raw-material constraints.
Retail and wholesale limits imposed by distributors.

These factors can support temporary pricing or market-share gains for suppliers with available inventory. They do not create durable pricing power comparable to patent exclusivity.

What is the competitive landscape for hydrocodone-acetaminophen?

The product competes across three levels.

Generic hydrocodone-acetaminophen products

Immediate-release tablets are the dominant commercial segment. Competition is based on:

Wholesale acquisition cost
Contract pricing
Supply reliability
Approved strengths
Pack sizes
Pharmacy and hospital distribution
Shortage availability
Payer and PBM formulary treatment

The market is highly substitutable. Products with equivalent strength and dosage form generally compete on price and availability.

Other opioid analgesics

Hydrocodone-acetaminophen competes with oxycodone-acetaminophen, commonly known as Percocet, tramadol, codeine combinations, and single-ingredient oxycodone or hydrocodone products. Prescribing depends on pain severity, patient history, prescriber preference, state law, and payer policy.

Non-opioid alternatives

Non-opioid alternatives include ibuprofen, naproxen, topical analgesics, local anesthetics, physical therapy, and multimodal pain-management protocols. CDC guidance encourages non-opioid therapies when appropriate and recommends limiting opioid exposure to the minimum effective dose and duration (Centers for Disease Control and Prevention [CDC], 2022).

What is the financial trajectory of acetaminophen-hydrocodone products?

The financial trajectory has four phases.

Period	Market condition	Financial effect
Pre-2010	Branded products and broad opioid prescribing	Higher brand value and larger prescription base
2010-2014	Generic substitution and acetaminophen safety intervention	Brand erosion and product reformulation
2014-2020	Schedule II controls and opioid stewardship	Lower utilization and greater compliance cost
2020 onward	Mature generic market with supply volatility	Low unit economics, intermittent shortage-driven opportunities

Revenue exposure

Public company filings rarely report revenue for acetaminophen-hydrocodone products as a separate line item. Companies generally group the product within generic pharmaceuticals, controlled substances, or broader analgesics. As a result, product-specific revenue cannot be reliably inferred from total company sales.

The commercial exposure is greatest for manufacturers with:

Multiple hydrocodone strengths.
High-volume retail contracts.
Hospital and government supply agreements.
Dedicated controlled-substance manufacturing capacity.
Established wholesaler relationships.

The largest financial risk is sustained volume decline. The principal upside is temporary share capture when competitors experience shortages, regulatory disruption, or quota constraints.

Margin profile

Margins are typically pressured by:

Numerous approved competitors.
Generic price erosion.
Large pharmacy and wholesaler buyers.
Product substitution across equivalent strengths.
Controlled-substance compliance costs.
Inventory and security requirements.
Litigation, monitoring, and settlement expenses related to opioid distribution.

A supplier with a differentiated formulation may achieve better pricing, but standard immediate-release tablets have limited defensible margin.

What is the impact of opioid prescribing restrictions on sales?

Opioid controls reduce the addressable prescription base and shorten treatment duration. Relevant measures include:

State prescribing-duration limits.
Prior authorization.
Prescription drug monitoring programs.
Mandatory electronic prescribing for controlled substances.
CDC prescribing guidance.
Pharmacy and wholesaler quantity controls.
Institutional opioid stewardship programs.

CDC data show a long-term decline in opioid prescribing from its peak in 2010, although prescribing remains substantial in the United States (CDC, 2024). The decline affects hydrocodone-acetaminophen through lower prescription counts, fewer tablets per prescription, and increased substitution toward non-opioid treatments.

The market is unlikely to return to its earlier growth profile without a major change in prescribing policy or clinical practice.

What is the current litigation and settlement status?

The product class is connected to broader opioid litigation involving manufacturers, distributors, pharmacies, and state and local governments. Those proceedings generally concern marketing, distribution, monitoring, and alleged contribution to opioid harms rather than infringement of a current patent covering standard hydrocodone-acetaminophen tablets.

Patent litigation

Current market access is not primarily constrained by patent litigation. Standard generic entrants generally face limited patent risk because the core combination is old and widely genericized.

Opioid litigation

Major opioid settlements have involved companies such as Johnson & Johnson, Teva, Allergan, CVS, Walgreens, and Walmart, among others. Settlement obligations can affect corporate cash flow and the economics of opioid portfolios, even when the individual hydrocodone-acetaminophen product is not separately disclosed (National Association of Attorneys General, 2024).

Paragraph IV challenges

Paragraph IV litigation is not a central current issue for the conventional product category. Generic approvals have been available for many years, and any remaining disputes are more likely to involve a particular formulation, supplier, or labeling issue than the basic immediate-release combination.

What generic entry risks exist?

Generic entry risk is high where a product remains commercially branded or where a supplier maintains above-market pricing. The main scenarios are:

Scenario	Likely market result
New ANDA approval for standard tablet	Price erosion and share fragmentation
Competitor re-enters after shortage	Loss of temporary supply premium
Additional strength approval	Greater substitution and contract pressure
Manufacturing disruption	Short-term share gain for available suppliers
New abuse-deterrent formulation	Potentially higher barriers but smaller addressable market
Regulatory tightening	Lower volumes and higher compliance costs

For investors and licensors, a standard immediate-release product should be valued as a mature generic asset, not as a protected specialty product.

How does hydrocodone-acetaminophen compare with oxycodone-acetaminophen?

Attribute	Hydrocodone-acetaminophen	Oxycodone-acetaminophen
Market status	Mature generic	Mature generic
Core use	Moderate to moderately severe pain	Moderate to moderately severe pain
Controlled-substance schedule	Schedule II	Schedule II
Patent barrier	Low for immediate-release products	Low for immediate-release products
Generic competition	Broad	Broad
Revenue profile	Volume-driven, low margin	Volume-driven, low margin
Abuse and diversion exposure	High	High
Main commercial differentiator	Supply, contract access, strength mix	Supply, contract access, strength mix

Neither product has strong category-level patent protection in its conventional immediate-release form. Differences in commercial performance depend more on prescribing patterns, state restrictions, shortage conditions, and contracting than on intellectual-property protection.

What is the biosimilar risk for acetaminophen-hydrocodone?

There is no biosimilar risk. Acetaminophen-hydrocodone is a chemically synthesized small-molecule combination product, not a biologic. Competition occurs through abbreviated new drug applications, not the FDA biosimilar pathway.

What geographic markets have the strongest commercial potential?

The United States is the principal commercial market because of its large prescription opioid market and extensive generic infrastructure. It is also the most heavily regulated market.

International opportunity is limited by:

Different opioid scheduling rules.
National reimbursement policies.
Tighter controlled-substance controls.
Lower hydrocodone use in many countries.
Preference for codeine, tramadol, oxycodone, or non-opioid therapies.
Import and narcotics licensing requirements.

Geographic expansion is therefore more dependent on regulatory registration and controlled-substance authorization than on patent clearance.

Key Takeaways

Acetaminophen and hydrocodone bitartrate is a mature generic analgesic category.
Vicodin, Norco, and Lortab no longer provide meaningful pioneer exclusivity.
Standard immediate-release tablets have limited current patent protection.
Formulation and manufacturing patents may matter for modified-release or abuse-deterrent products.
The FDA limits prescription combination products to 325 mg or less of acetaminophen per dosage unit.
Hydrocodone combinations are Schedule II products, creating quota, prescribing, distribution, and compliance barriers.
Revenue is generally low-margin and volume-driven.
Long-term prescription decline is the dominant market trend.
Temporary commercial gains can arise from competitor shortages or supply disruptions.
Patent litigation is less important than generic price erosion, opioid regulation, and supply reliability.
There is no biosimilar pathway or biosimilar threat for this small-molecule combination.

FAQs

Is hydrocodone-acetaminophen still commercially profitable?

It can be profitable for manufacturers with efficient production, reliable DEA quota, and strong distribution contracts. Standard products generally have limited pricing power and low margins.

Are Vicodin and Norco still protected by patents?

Their core immediate-release formulations are not protected by active pioneer patents that prevent ordinary generic competition. Product-specific Orange Book records must be assessed by NDA and dosage form.

Can a company launch a generic hydrocodone-acetaminophen tablet without patent litigation?

For a conventional immediate-release product, patent risk is generally limited because the combination is long established. A proposed product still requires ANDA approval and a complete review of the applicable reference product and Orange Book records.

Does acetaminophen content create a regulatory barrier?

Yes. FDA safety policy limits prescription combination products to 325 mg or less of acetaminophen per dosage unit. Products with higher acetaminophen content face significant regulatory and commercial obstacles.

What is the largest threat to future hydrocodone-acetaminophen revenue?

The largest threat is declining opioid utilization caused by prescribing controls, shorter treatment duration, non-opioid substitution, payer restrictions, and continued scrutiny of controlled-substance distribution.

References

Centers for Disease Control and Prevention. (2022). CDC clinical practice guideline for prescribing opioids for pain: United States, 2022. U.S. Department of Health and Human Services.
Centers for Disease Control and Prevention. (2024). U.S. opioid dispensing rate maps, 2006-2022. U.S. Department of Health and Human Services.
Drug Enforcement Administration. (2014). Schedules of controlled substances: Placement of hydrocodone combination products into Schedule II. U.S. Department of Justice.
National Association of Attorneys General. (2024). Opioid settlements and resolution agreements. National Association of Attorneys General.
U.S. Food and Drug Administration. (2014). FDA asks manufacturers to withdraw prescription products with more than 325 mg of acetaminophen; recommends limiting acetaminophen in prescription combination products. U.S. Department of Health and Human Services.
U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: The Orange Book. U.S. Department of Health and Human Services.

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	8
Patent Applications:	661
DailyMed Link:	ACETAMINOPHEN AND HYDROCODONE BITARTRATE at DailyMed

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