Last updated: November 2, 2026
Hydrocodone bitartrate and ibuprofen is a mature, genericized opioid-NSAID combination with limited pricing power and declining strategic importance. The reference product, Vicoprofen, was approved by the FDA in 1997 for short-term acute pain management. Its commercial opportunity is constrained by Schedule II controls, opioid-prescribing restrictions, generic substitution, competition from hydrocodone-acetaminophen products, and broader movement toward non-opioid analgesics.
Public companies do not generally disclose revenue for hydrocodone bitartrate and ibuprofen as a standalone product. The market is fragmented among generic manufacturers, wholesalers, retail pharmacies and institutional buyers. Its financial trajectory is therefore best assessed through prescription volume, generic pricing, regulatory restrictions, manufacturing continuity and opioid-market trends rather than reported brand revenue.
What is hydrocodone bitartrate and ibuprofen?
Hydrocodone bitartrate and ibuprofen is an oral fixed-dose combination of an opioid agonist and a nonsteroidal anti-inflammatory drug. The original Vicoprofen strength contains 7.5 mg hydrocodone bitartrate and 200 mg ibuprofen per tablet.
| Attribute |
Product information |
| Active ingredients |
Hydrocodone bitartrate and ibuprofen |
| Common strength |
7.5 mg/200 mg tablet |
| Original brand |
Vicoprofen |
| Original sponsor |
Knoll Pharmaceutical Company |
| FDA approval |
1997 |
| Dosage form |
Immediate-release oral tablet |
| Controlled-substance status |
Schedule II opioid |
| Primary use |
Short-term acute pain |
| Generic status |
Available from multiple manufacturers |
| Commercial position |
Mature, low-growth generic product |
The product combines hydrocodone’s analgesic effect with ibuprofen’s anti-inflammatory activity. The combination can provide opioid-sparing analgesia relative to hydrocodone alone, but it also creates dose-related risks from both components. Hydrocodone creates dependence, respiratory-depression and diversion risks. Ibuprofen creates gastrointestinal, renal and cardiovascular risks, particularly at higher cumulative exposure.
The FDA label limits use to situations in which treatment with an opioid is appropriate and requires prescribing at the lowest effective dose for the shortest practical duration (FDA, 2023).
When did hydrocodone bitartrate and ibuprofen lose exclusivity?
The product lost meaningful commercial exclusivity years ago. Vicoprofen was approved in the late 1990s, and the market now consists primarily of generic versions rather than a premium-priced branded product.
The relevant exclusivity framework is historical:
- The original product was approved in 1997.
- Any original Hatch-Waxman market protection has expired.
- Any original formulation patents would have expired before the current commercial period.
- The product has no meaningful remaining new-chemical-entity exclusivity.
- Generic substitution is established in the FDA-approved market.
The FDA Orange Book continues to provide the controlling source for active patent and exclusivity entries. For a mature hydrocodone/ibuprofen product, the practical question is not whether the original brand has protection, but whether a particular generic manufacturer maintains an approved, commercially viable product and supply chain (FDA, 2024a).
What patents protect hydrocodone bitartrate and ibuprofen?
No commercially significant active patent moat is generally associated with the original hydrocodone bitartrate and ibuprofen tablet. The core drug composition is old, the product is immediate release, and multiple generic manufacturers have entered the market.
Patent protection can still arise around narrow technical claims, including:
Formulation patents
Potential formulation claims could cover:
- Modified-release or abuse-deterrent delivery systems
- Tablet coatings
- Excipient combinations
- Dissolution profiles
- Manufacturing processes
- Stability improvements
- Alternative dosage strengths
Those claims would not necessarily block standard immediate-release generic tablets. A company would need a commercially differentiated formulation and a corresponding FDA-approved product to create meaningful value.
Method-of-use patents
Method-of-use patents could cover selected acute-pain indications, dosing regimens or patient populations. Their value is limited because the product’s principal use is a broad, established acute-pain indication. Generic manufacturers may use labeling strategies that omit protected indications where legally permissible.
Manufacturing and supply-chain barriers
Manufacturing barriers are more relevant than patent barriers. Hydrocodone is a controlled substance, so manufacturers must comply with DEA registration, procurement quotas, security requirements, recordkeeping and distribution controls. The ibuprofen component is widely available and does not create a comparable supply constraint.
What is the FDA regulatory status of hydrocodone bitartrate and ibuprofen?
Hydrocodone bitartrate and ibuprofen is an FDA-approved prescription product. It is regulated as a combination drug containing a Schedule II opioid.
The regulatory profile has four commercial effects:
- Prescriptions cannot be refilled under the federal Controlled Substances Act.
- Pharmacies and wholesalers face controlled-substance compliance obligations.
- Manufacturers require appropriate DEA registrations and quota access.
- State opioid laws may impose additional prescribing, dispensing or monitoring requirements.
Hydrocodone combination products containing acetaminophen are more widely recognized in the market, but hydrocodone/ibuprofen has a distinct safety profile because it avoids acetaminophen exposure while retaining NSAID toxicity. This distinction can influence physician selection, although payer formularies and prescribing protocols often favor less expensive alternatives.
What is the Orange Book status of Vicoprofen and its generic equivalents?
The original commercial product is now a legacy reference product. The FDA Orange Book is the principal source for determining whether a listed drug has active patents, regulatory exclusivity or therapeutic-equivalence evaluations.
For business purposes, the product should be treated as an off-patent, multisource prescription drug:
| Orange Book issue |
Commercial assessment |
| Active original exclusivity |
Not commercially relevant |
| Original patent barrier |
Expired or otherwise non-blocking for generic entry |
| Generic availability |
Established |
| Therapeutic-equivalence significance |
Relevant to substitution |
| Paragraph IV value |
Low for the legacy product |
| Regulatory differentiation |
Limited unless tied to a new formulation |
A current Orange Book review should be performed at the product and strength level because listings can change as sponsors withdraw products, transfer approvals or add new patent certifications.
How many manufacturers compete in the hydrocodone/ibuprofen market?
Competition is broad relative to the product’s remaining commercial value. Generic manufacturers have historically included large multisource suppliers and specialty generic companies. Availability can vary by strength, package size, wholesaler inventory and controlled-substance quota.
The competitive structure has four tiers:
- Large generic manufacturers with national distribution
- Mid-sized manufacturers with limited or regional supply
- Contract manufacturers and private-label suppliers
- Retail and institutional pharmacy channels purchasing through wholesalers
Because hydrocodone is controlled, a nominally approved manufacturer may not maintain continuous commercial supply. DEA quota, active pharmaceutical ingredient access, manufacturing capacity and quality-system status can influence actual market share more than patent ownership.
What is the financial trajectory for hydrocodone bitartrate and ibuprofen?
The financial trajectory is mature-to-declining, with intermittent supply-driven price volatility.
Revenue profile
Vicoprofen does not represent a major current branded revenue opportunity. The branded product lacks the exclusivity needed to sustain premium pricing, and generic versions capture most demand.
Public disclosures generally do not separate hydrocodone/ibuprofen revenue from broader generic portfolios. As a result:
- Standalone annual market revenue is not reliably available from issuer filings.
- Manufacturer-specific sales are usually aggregated into generic pharmaceuticals.
- Prescription volume and average selling price are more useful than reported brand revenue.
- Any revenue estimate based on total hydrocodone prescriptions would materially overstate the hydrocodone/ibuprofen opportunity.
Pricing
Generic pricing is generally low, but pricing can rise temporarily when:
- A manufacturer exits the market
- DEA quota limits production
- An FDA manufacturing warning reduces supply
- A wholesaler experiences inventory disruption
- Demand shifts away from another opioid combination
- A small number of suppliers control available stock
These events can produce short-term gross-margin expansion. They do not create durable pricing power unless supply remains concentrated.
Volume
Long-term unit demand is pressured by:
- Reduced opioid prescribing
- State and federal prescribing restrictions
- Prescription drug monitoring programs
- Greater use of NSAIDs, acetaminophen and non-opioid therapies
- Payer controls
- Dental and postsurgical prescribing changes
- Public and institutional efforts to reduce opioid exposure
The decline is partly offset by continued demand for acute pain treatment and by clinical situations in which an NSAID-opioid combination is preferred to hydrocodone-acetaminophen.
How does hydrocodone/ibuprofen compare with hydrocodone/acetaminophen?
| Factor |
Hydrocodone/ibuprofen |
Hydrocodone/acetaminophen |
| Opioid component |
Hydrocodone |
Hydrocodone |
| Non-opioid component |
Ibuprofen |
Acetaminophen |
| Main added risk |
GI, renal and cardiovascular NSAID toxicity |
Hepatotoxicity at excessive acetaminophen exposure |
| Market breadth |
Narrower |
Broader historical use |
| Generic competition |
High |
Very high |
| Brand differentiation |
Limited |
Limited |
| Commercial growth |
Low or declining |
Low or declining |
| Clinical positioning |
Acute inflammatory pain |
Broad acute pain use |
Hydrocodone/ibuprofen may be attractive when avoiding acetaminophen is clinically relevant. The product is less attractive for patients with gastrointestinal bleeding risk, renal impairment, cardiovascular risk or NSAID intolerance.
Which companies are challenging the product commercially?
Commercial competition comes mainly from generic manufacturers rather than from companies pursuing high-value patent litigation. The relevant competitors include:
- Generic hydrocodone/ibuprofen products
- Hydrocodone/acetaminophen products
- Oxycodone/acetaminophen products
- Tramadol-based products
- Standalone ibuprofen and naproxen
- Acetaminophen
- Non-opioid postoperative pain regimens
The competitive threat is therefore substitution across therapeutic categories, not only direct tablet-for-tablet competition.
What patent litigation and Paragraph IV risks exist?
The legacy product has limited current Paragraph IV litigation value. Paragraph IV litigation is most economically significant when a generic applicant challenges an active patent protecting a high-revenue branded drug. Hydrocodone bitartrate and ibuprofen does not fit that profile.
Potential litigation could still arise from:
- A new extended-release formulation
- An abuse-deterrent formulation
- A branded reformulation with new clinical data
- A manufacturing process patent
- A dispute over ANDA labeling or equivalence
- Product liability claims involving opioid use or NSAID toxicity
Any litigation involving the legacy product would more likely concern product liability, manufacturing quality, supply contracts or regulatory compliance than core composition-of-matter exclusivity.
What generic launch scenarios exist?
Base case: stable generic supply with declining volume
This is the most likely scenario. Multiple suppliers remain active, pricing remains low, and demand gradually declines with opioid utilization.
Upside case: temporary shortage and price expansion
A manufacturing shutdown, quota constraint or supplier exit could raise prices and increase margins for remaining manufacturers. The effect would likely be temporary.
Downside case: accelerated substitution
Expanded use of non-opioid analgesics, tighter state restrictions or reduced postoperative opioid prescribing could reduce demand faster than expected.
Differentiated-product case
A sponsor could pursue an abuse-deterrent, modified-release or clinically differentiated formulation. The development burden would be substantial, and the addressable market would remain limited unless the product obtained favorable payer coverage and demonstrated a clear clinical advantage.
How strong is the patent estate and what are the geographic risks?
The legacy patent estate is weak. Commercial defensibility depends on regulatory execution, controlled-substance manufacturing capability and supply reliability rather than exclusionary patent rights.
Geographic exposure differs by market:
- In the United States, Schedule II controls and state opioid rules are central.
- In Canada and other markets, opioid scheduling, reimbursement and formulary access differ.
- International demand is limited by country-specific opioid controls and the availability of other analgesics.
- U.S. generic economics are affected by wholesaler concentration and pharmacy purchasing behavior.
The United States remains the principal commercial market for this specific fixed-dose combination, but its mature generic profile limits global expansion potential.
What revenue exposure should investors and licensors assume?
Investors should assume limited direct revenue exposure unless a company has a concentrated generic portfolio, a temporary supply advantage or a differentiated formulation.
The product can contribute:
- Incremental generic revenue
- Manufacturing-volume utilization
- Controlled-substance portfolio breadth
- Short-term shortage pricing
- Cross-selling through hospital or retail pharmacy contracts
It is unlikely to support:
- A durable branded premium
- Significant patent-driven valuation
- Large licensing economics
- A material standalone growth thesis
The most relevant financial indicators are product availability, number of active suppliers, wholesaler pricing, FDA compliance status, DEA quota access and prescription-volume trends.
Key Takeaways
- Hydrocodone bitartrate and ibuprofen is a mature, off-patent generic analgesic.
- Vicoprofen, the original brand, no longer has meaningful commercial exclusivity.
- The FDA-approved product is typically the 7.5 mg/200 mg immediate-release tablet.
- Patent risk is low; manufacturing, DEA quota and supply-chain risk are more important.
- Revenue is fragmented and not generally disclosed as a standalone line item.
- Long-term market volume is pressured by opioid controls and substitution by non-opioid therapies.
- Temporary shortages can produce price increases, but the product has limited durable pricing power.
- A new abuse-deterrent or modified-release formulation would be required to create a meaningful new patent opportunity.
- The primary competitive threat comes from hydrocodone/acetaminophen, other opioids and non-opioid analgesics.
- The financial outlook is stable-to-declining, with episodic supply-driven volatility.
FAQs About Hydrocodone Bitartrate and Ibuprofen
Is hydrocodone bitartrate and ibuprofen still commercially available?
Yes. Generic versions of the FDA-approved combination remain available, although inventory can vary by manufacturer, pharmacy and wholesaler.
Is Vicoprofen still a growth product?
No. Vicoprofen is a legacy branded product without meaningful current exclusivity. Growth potential is limited unless tied to a new formulation or temporary generic supply disruption.
Does hydrocodone/ibuprofen have a stronger market position than hydrocodone/acetaminophen?
No. Hydrocodone/acetaminophen has historically had broader market penetration. Hydrocodone/ibuprofen has a narrower clinical position because NSAID toxicity limits use in some patients.
Can a generic manufacturer obtain premium pricing for hydrocodone/ibuprofen?
Only under constrained conditions, such as a shortage, supplier exit or controlled-substance quota disruption. Generic competition generally prevents sustained premium pricing.
Is biosimilar competition relevant to hydrocodone bitartrate and ibuprofen?
No. Hydrocodone bitartrate and ibuprofen is a chemically synthesized small-molecule combination, not a biologic. Competition occurs through generic ANDA products rather than biosimilars.
References
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Food and Drug Administration. (2023). Hydrocodone bitartrate and ibuprofen tablets: Prescribing information. U.S. Department of Health and Human Services.
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Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.
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Food and Drug Administration. (2024b). Abbreviated new drug application approvals and drug databases. U.S. Department of Health and Human Services.
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Drug Enforcement Administration. (2024). Drug scheduling and controlled-substance requirements. U.S. Department of Justice.
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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.
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U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417.
