ASPIRIN; HYDROCODONE BITARTRATE - Generic Drug Details

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

Aspirin; hydrocodone bitartrate is the generic ingredient in three branded drugs marketed by Schwarz Pharma, Lgm Pharma, and Abbott, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ASPIRIN; HYDROCODONE BITARTRATE

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
DailyMed Link:	ASPIRIN; HYDROCODONE BITARTRATE at DailyMed

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lgm Pharma	HYDROCODONE BITARTRATE AND ASPIRIN	aspirin; hydrocodone bitartrate	TABLET;ORAL	205479-001	May 28, 2021		RX	No	Yes
Abbott	VICOPRIN	aspirin; hydrocodone bitartrate	TABLET;ORAL	086333-001	Sep 14, 1983		DISCN	No	No
Schwarz Pharma	AZDONE	aspirin; hydrocodone bitartrate	TABLET;ORAL	089420-001	Jan 25, 1988		DISCN	No	No

Aspirin and Hydrocodone Bitartrate Market Dynamics and Financial Trajectory

Last updated: September 6, 2026

Aspirin and hydrocodone bitartrate occupy opposite positions in the pharmaceutical market. Aspirin is a mature, low-cost over-the-counter and prescription ingredient with minimal patent protection and stable demand in pain, fever, cardiovascular, and secondary stroke prevention. Hydrocodone bitartrate remains a prescription opioid with meaningful clinical demand, but its market has contracted under tighter controls, opioid stewardship, payer pressure, and generic price competition.

The commercially relevant products are largely separate. Hydrocodone is commonly combined with acetaminophen or ibuprofen, while aspirin is sold independently or with other analgesics. A current, large-scale U.S. market for an aspirin-hydrocodone fixed-dose combination is not established.

What is the current market position of aspirin?

Aspirin is a mature commodity pharmaceutical with broad global availability and limited product differentiation. Its main commercial channels are:

Segment	Principal use	Market position
OTC analgesic	Headache, musculoskeletal pain, fever	Low-price, highly competitive
Cardiovascular prevention	Secondary prevention of myocardial infarction and ischemic stroke	Stable clinical demand, subject to guideline changes
Hospital and acute care	Acute coronary syndrome and procedural use	Established, low-cost standard
Combination products	Cough, cold, analgesic, and gastrointestinal products	Brand- and channel-dependent
Industrial and pharmaceutical ingredient	Manufacturing input	Commodity pricing

In the United States, aspirin products are regulated primarily through the FDA’s OTC monograph framework and approved applications. The OTC monograph identifies aspirin as an active ingredient for certain analgesic, antipyretic, and menstrual pain indications, subject to specified conditions of use (FDA, 2023a).

The market is divided between branded products such as Bayer Aspirin, private-label store brands, hospital products, and generic prescription products. Private-label aspirin places sustained pressure on retail pricing. Brand value is concentrated in consumer recognition, packaging, distribution, and clinical familiarity rather than patent exclusivity.

What is the financial trajectory for aspirin?

Aspirin revenue is structurally stable but low growth. The principal financial characteristics are:

• High unit volume.
• Low average selling prices.
• Limited patent-driven pricing power.
• Strong private-label substitution.
• Modest growth from population aging and cardiovascular disease prevalence.
• Periodic demand changes caused by prevention-guideline revisions.

Aspirin’s financial trajectory is therefore driven by volume, channel mix, manufacturing efficiency, and brand strength. It is not driven by exclusivity-based price expansion.

Cardiovascular prevention has produced a more complex demand profile. Aspirin remains important for patients with established cardiovascular disease, but routine primary prevention has narrowed in several guideline frameworks because bleeding risk can outweigh benefit in some populations (USPSTF, 2022). That distinction limits growth in new users while preserving demand among patients receiving secondary prevention.

Aspirin revenue exposure by commercial model

Commercial model	Margin profile	Growth outlook	Principal risk
National consumer brand	Moderate	Low to moderate	Private-label substitution
Retail private label	Low	Low	Retailer pricing pressure
Hospital supply	Low	Low	Procurement consolidation
Specialty or combination product	Variable	Product-specific	Substitution and regulation
API manufacturing	Low to moderate	Low	Global capacity and input costs

Manufacturers with efficient supply chains can maintain acceptable margins despite low prices. Retail brands with strong shelf placement and consumer recognition can preserve a premium, but that premium is vulnerable to retailer-owned alternatives.

What is the current market position of hydrocodone bitartrate?

Hydrocodone bitartrate is a controlled opioid ingredient used in immediate-release and extended-release prescription products. The major commercial categories are:

1. Hydrocodone-acetaminophen combination tablets and capsules.
2. Hydrocodone-ibuprofen combination products.
3. Extended-release hydrocodone products, including abuse-deterrent formulations.
4. Hydrocodone-containing oral solutions and other dosage forms.

Hydrocodone-acetaminophen products account for the largest practical commercial exposure. Common brand references include Vicodin and related historical products, but the market is primarily generic. Extended-release products such as Hysingla ER target chronic pain and have a smaller market than immediate-release combination products.

Hydrocodone combination products became subject to Schedule II controls in the United States in October 2014. The change eliminated refills and required more restrictive prescribing procedures, increasing administrative friction and reducing some chronic and marginal use (DEA, 2014).

How has hydrocodone demand changed?

Hydrocodone demand has declined from its earlier peak in the United States. The decline reflects:

• Prescription-volume controls.
• State and federal opioid-prescribing limits.
• Greater use of non-opioid analgesics.
• Prescription drug monitoring programs.
• Tighter payer utilization management.
• Reduced use for chronic non-cancer pain.
• Lower opioid exposure after surgery and acute injury.
• Public and institutional response to opioid-related morbidity and mortality.

The market has not disappeared. Hydrocodone remains used for acute postoperative pain, traumatic injury, severe dental pain, and selected chronic-pain cases. Demand is concentrated in clinically justified prescriptions rather than broad primary-care prescribing.

The CDC’s opioid prescribing guidance emphasizes non-opioid therapies when appropriate and recommends the lowest effective opioid dose for the shortest practical duration when opioids are used (CDC, 2022). This guidance affects volume, prescription duration, and payer behavior.

What is the financial trajectory for hydrocodone bitartrate?

Hydrocodone’s financial trajectory is characterized by falling volume, generic price erosion, and a shift toward lower-risk, higher-control commercial segments.

Financial driver	Direction	Effect on manufacturers
Prescription volume	Down from historical peak	Reduces revenue
Generic competition	Intensifying	Compresses price
Regulatory compliance	Increasing cost	Raises operating expense
Abuse-deterrent technology	Potential premium	Supports selected products
Shorter treatment duration	Downward pressure	Reduces units per prescription
Supply disruptions	Volatile	Can temporarily support pricing
Litigation and monitoring	Higher cost	Reduces net profitability

For generic immediate-release products, revenue depends heavily on manufacturing scale, supply reliability, wholesaler contracts, and participation in government and managed-care channels. Product-level revenue data are often not disclosed separately because manufacturers report broader generic or controlled-substance categories.

Brand and specialty hydrocodone products face a different economic model. They can command higher prices when supported by differentiated delivery technology, abuse-deterrent features, or a distinct clinical profile. Those advantages are offset by smaller eligible populations, payer restrictions, surveillance obligations, and limited prescriber adoption.

What patents protect aspirin products?

The aspirin molecule is long off patent. Ordinary aspirin tablets, capsules, chewables, powders, and standard solutions generally do not have meaningful remaining composition-of-matter exclusivity.

Current protection, where it exists, is more likely to involve:

• Trade dress and trademarks.
• Particular packaging systems.
• Specialized dosage forms.
• Enteric coatings.
• Effervescent delivery systems.
• Combination-product formulations.
• Manufacturing processes.
• Device or dispensing systems.

These rights generally do not prevent a generic manufacturer from selling conventional aspirin in a therapeutically equivalent dosage form.

Aspirin patent strength

Patent category	Typical status	Commercial significance
Aspirin composition of matter	Expired	None for exclusivity
Standard tablet formulation	Generally expired or readily design-around	Low
Enteric coating	Often old or narrow	Low to moderate
Combination formulation	Product-specific	Variable
Packaging and branding	Potentially active	Commercial rather than pharmaceutical exclusivity
Manufacturing process	Potentially active	Usually limited to process infringement

Aspirin’s principal barriers are regulatory compliance, quality control, procurement access, and brand distribution. Patent litigation is not the central competitive issue.

What patents protect hydrocodone bitartrate products?

Hydrocodone bitartrate is also an old active ingredient. The original molecule and conventional immediate-release formulations do not provide a meaningful modern patent barrier. Patent value has shifted toward:

• Extended-release formulations.
• Abuse-deterrent dosage forms.
• Controlled-release matrices.
• Tamper-resistant coatings.
• Multiparticulate systems.
• Dose-proportional release profiles.
• Manufacturing processes.
• Combination products.
• Method-of-use claims.

The strength of these patents depends on claim scope, written-description support, enablement, prosecution history, and the availability of alternative formulations. A patent covering a specific abuse-deterrent matrix may protect one commercial product without blocking conventional immediate-release hydrocodone products.

What is the Orange Book status of hydrocodone products?

FDA Orange Book treatment is product-specific. Listed patents and regulatory exclusivities depend on the approved application, dosage form, strength, and sponsor. Conventional generic hydrocodone-acetaminophen products generally compete against mature reference products with limited remaining patent protection.

Extended-release hydrocodone products can have more relevant Orange Book protection because their commercial value depends on release technology and formulation design. Listed patents may cover release mechanisms, abuse-deterrent properties, or methods of use. Orange Book listing alone does not establish that a patent will withstand Paragraph IV litigation.

The FDA Orange Book remains the principal public source for approved products, reference listed drugs, therapeutic equivalence evaluations, and certain listed patents (FDA, 2023b).

When does hydrocodone lose exclusivity?

Hydrocodone’s base active ingredient has already lost exclusivity. The relevant timing question is product-specific:

• Immediate-release hydrocodone-acetaminophen products: largely generic and mature.
• Hydrocodone-ibuprofen products: generic competition is established.
• Extended-release products: timing depends on formulation patents, regulatory exclusivity, and product-specific litigation.
• Abuse-deterrent products: protection depends on formulation claims and the viability of non-infringing alternatives.

For mature products, the commercial risk is usually not first generic entry. It is continued price erosion as multiple suppliers compete for formulary and wholesaler volume.

Which companies compete in the aspirin market?

The aspirin market includes branded, generic, private-label, and hospital suppliers. Relevant commercial participants include:

• Bayer, through Bayer Aspirin and related consumer products.
• Perrigo, through store-brand and private-label OTC manufacturing.
• Retail pharmacy chains and mass merchants, which sell private-label aspirin.
• Generic pharmaceutical manufacturers supplying prescription and institutional channels.
• Regional and international consumer-health companies.

Brand ownership and manufacturing arrangements vary by geography. In many markets, the company on the package is not the same company that manufactures the active ingredient or finished product.

Which companies compete in the hydrocodone market?

The hydrocodone market includes generic manufacturers, specialty pharmaceutical companies, contract manufacturers, and controlled-substance distributors. Competitive participation has included companies such as:

• Amneal Pharmaceuticals.
• Hikma Pharmaceuticals.
• Mallinckrodt and its SpecGx business.
• Rhodes Pharmaceuticals.
• Purdue Pharma-related entities and successors in historical branded markets.
• Other approved ANDA holders and contract manufacturers.

The competitive landscape changes with supply allocations, DEA production quotas, manufacturing shutdowns, recalls, litigation settlements, and wholesaler contracting. A company’s approved product does not guarantee continuous market supply.

What generic entry risks exist for aspirin and hydrocodone?

Aspirin

Generic entry risk is already fully realized for conventional aspirin. New entrants mainly create price pressure rather than a discrete loss-of-exclusivity event. Commercial differentiation depends on:

• Retail placement.
• Brand recognition.
• Packaging.
• Supply reliability.
• Private-label contracts.
• Claims permitted under FDA regulation.

Hydrocodone

Hydrocodone generic risk is also mature for conventional products. The main exposure is continuing erosion from additional ANDA suppliers and contract-manufacturing capacity. For extended-release or abuse-deterrent products, the risk is more technical:

• Paragraph IV certifications.
• Formulation design-arounds.
• Challenges to listed patents.
• Alternative opioid or non-opioid products.
• Regulatory restrictions on substitution.
• Payer preference for lower-cost immediate-release products.

A generic applicant may challenge Orange Book patents under Paragraph IV of the Hatch-Waxman Act. The result can be patent litigation, a 30-month stay in applicable circumstances, negotiated entry, or an earlier launch if the challenger prevails or reaches a settlement.

What patent litigation and settlements affect these markets?

Aspirin has little current product-specific patent litigation of commercial importance. Disputes generally concern trademarks, labeling, packaging, manufacturing, or combination products.

Hydrocodone litigation has been more relevant around formulation patents and opioid-market conduct than around the basic active ingredient. Litigation exposure includes:

• ANDA challenges involving extended-release formulations.
• Patent disputes over abuse-deterrent technology.
• Product-liability claims.
• Government investigations and settlements involving opioid marketing and distribution.
• Bankruptcy-related resolution of opioid liabilities.

Settlement agreements can delay generic entry, permit licensed entry, or impose commercial restrictions. Their economic effect depends on the entry date, authorized-generic rights, supply terms, and remaining patent life. Public settlement terms are not always sufficient to determine actual launch timing.

How do aspirin and hydrocodone compare commercially?

Metric	Aspirin	Hydrocodone bitartrate
Primary market	OTC and institutional	Prescription controlled substance
Patent position	Effectively mature	Mature active ingredient; formulation-specific protection
Pricing power	Very low to moderate for brands	Low for generics; higher for differentiated ER products
Demand trend	Stable, with indication-specific shifts	Downward from historical U.S. peak
Regulatory burden	Standard OTC and prescription compliance	High controlled-substance burden
Main competitors	Private label and branded OTC products	Generic manufacturers and alternative analgesics
Litigation risk	Low	Moderate to high, depending on product
Revenue visibility	Broad volume, low unit value	Narrower volume, higher compliance and liability costs
Main commercial barrier	Distribution and cost	Regulation, supply control, formulation, and liability

What is the geographic coverage of these markets?

Aspirin has broad global coverage because it is inexpensive, chemically stable, and familiar to health systems. Demand is strongest where OTC self-care and cardiovascular medicine are established. Regulatory status varies by country, particularly for preventive labeling and combination products.

Hydrocodone has a narrower international footprint. The United States is the principal commercial market because hydrocodone prescribing is more established there than in many other countries. International opioid markets often rely more heavily on codeine, oxycodone, morphine, tramadol, or non-opioid analgesics. National controlled-substance rules materially affect registration, distribution, prescribing, and reimbursement.

What is the outlook for manufacturing and intellectual-property barriers?

Aspirin manufacturing barriers are operational rather than patent-based. Producers must control impurity levels, tablet quality, coating performance, stability, packaging, and supply continuity. The API is inexpensive and widely available, which limits the ability of any single manufacturer to sustain high margins.

Hydrocodone manufacturing barriers are higher. Manufacturers must manage:

• DEA registration and quotas.
• Controlled-substance security.
• Inventory reconciliation.
• Diversion controls.
• Specialized production and packaging.
• Regulatory inspections.
• Product serialization and distribution records.
• Recall and adverse-event obligations.

These barriers can reduce the number of reliable suppliers even when patents do not block entry. Temporary shortages can increase the value of manufacturing capacity, but they do not necessarily create durable pricing power.

Key Takeaways

• Aspirin is a mature, low-margin product with stable volume and little meaningful patent exclusivity.
• Aspirin revenue depends on branding, private-label contracts, distribution, and manufacturing efficiency.
• Hydrocodone bitartrate has no meaningful remaining exclusivity at the active-ingredient level.
• Hydrocodone revenue has declined from historical U.S. highs because of prescribing controls, payer restrictions, and opioid stewardship.
• Conventional hydrocodone products face mature generic competition and continuing price erosion.
• Extended-release and abuse-deterrent hydrocodone products can retain formulation-based patent value, but their addressable markets are smaller.
• The principal hydrocodone barriers are controlled-substance regulation, manufacturing compliance, supply restrictions, and liability exposure.
• A large current market for an aspirin-hydrocodone fixed-dose product is not established.
• Aspirin is primarily a volume and distribution business. Hydrocodone is primarily a regulated supply, formulation, and compliance business.

FAQs

Is aspirin still a profitable pharmaceutical product?

Yes, but profitability depends on scale, branding, private-label contracts, and manufacturing cost. Conventional aspirin has limited unit economics and little patent-based pricing power.

Is hydrocodone bitartrate still under patent?

The active ingredient is long off patent. Some extended-release and abuse-deterrent formulations may have product-specific patents, but those patents do not generally block conventional generic hydrocodone products.

Does aspirin require a prescription in the United States?

Most standard aspirin products are sold over the counter. Certain dosage forms, strengths, combinations, or institutional products may be marketed through approved prescription applications or professional channels.

Why has hydrocodone revenue declined?

Revenue has declined because prescription volume, treatment duration, and chronic-use rates have fallen under tighter regulation, clinical guidance, payer controls, and opioid-risk management.

Is an aspirin-hydrocodone combination commercially important?

No large current U.S. market is established for that combination. Commercial hydrocodone products more commonly contain acetaminophen or ibuprofen, while aspirin is generally sold separately.

References

Centers for Disease Control and Prevention. (2022). CDC clinical practice guideline for prescribing opioids for pain: United States, 2022. https://www.cdc.gov/overdose-prevention/hcp/clinical-guidance

Drug Enforcement Administration. (2014). Schedules of controlled substances: Placement of hydrocodone combination products into Schedule II. Federal Register, 79, 49661-49682. https://www.federalregister.gov

U.S. Food and Drug Administration. (2023a). 21 CFR Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-343

U.S. Food and Drug Administration. (2023b). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book

U.S. Preventive Services Task Force. (2022). Aspirin use to prevent cardiovascular disease: Preventive medication. JAMA, 327(16), 1577-1584. https://doi.org/10.1001/jama.2022.4983