Last updated: September 4, 2026
Hydrocodone bitartrate/ibuprofen is a mature, genericized opioid analgesic combination marketed originally as Vicoprofen. The U.S. product contains hydrocodone bitartrate 7.5 mg and ibuprofen 200 mg per tablet and is approved for short-term management of acute pain severe enough to require an opioid when alternatives are inadequate.[1] Its commercial value has declined because of generic competition, opioid prescribing restrictions, payer controls, and the limited duration of authorized use.
The combination has no meaningful branded exclusivity remaining. Financial exposure is concentrated in low-margin generic supply, contract manufacturing, controlled-substance compliance, and product availability rather than in premium pricing or patent-protected revenue.
What is hydrocodone bitartrate/ibuprofen?
Hydrocodone bitartrate/ibuprofen combines an opioid agonist with a nonsteroidal anti-inflammatory drug.
| Attribute |
Product detail |
| Active ingredients |
Hydrocodone bitartrate and ibuprofen |
| Common strength |
Hydrocodone bitartrate 7.5 mg/ibuprofen 200 mg |
| Original brand |
Vicoprofen |
| Dosage form |
Immediate-release oral tablet |
| FDA application |
NDA 20-716 |
| Therapeutic use |
Short-term acute pain |
| Controlled-substance status |
Schedule II in the United States |
| Typical competitive products |
Hydrocodone/acetaminophen, oxycodone/acetaminophen, tramadol, NSAIDs, nonopioid multimodal regimens |
| Current market structure |
Generic and contract-manufactured supply |
The product was designed to combine hydrocodone's analgesic effect with ibuprofen's anti-inflammatory activity. Its clinical use is constrained by two safety liabilities: opioid dependence and respiratory depression from hydrocodone, and gastrointestinal, renal, cardiovascular, and bleeding risks from ibuprofen.[1]
When did Vicoprofen lose exclusivity?
Vicoprofen lost practical market exclusivity years ago. The original FDA approval dates to the late 1990s, and generic hydrocodone/ibuprofen products have been approved for many years under abbreviated new drug applications.[1][2]
| Exclusivity category |
Status |
| New chemical entity exclusivity |
Expired |
| Brand product exclusivity |
Expired |
| Generic entry barrier |
No material remaining barrier identified in the public FDA record |
| Patent-based branded pricing |
No longer commercially relevant |
| Regulatory pathway for competitors |
ANDA approval demonstrating bioequivalence |
| Market protection today |
Manufacturing capacity, supply contracts, controlled-substance quotas, and distribution access |
The product is no longer an investable branded-exclusivity asset. Any remaining value comes from manufacturing scale, supply reliability, portfolio positioning, and access to institutional or retail pharmacy channels.
What patents protect hydrocodone bitartrate and ibuprofen?
The principal commercial composition is no longer protected by a live, product-defining patent estate that supports branded pricing in the U.S. The relevant commercial protections were tied primarily to the original combination product and its regulatory approval rather than to a durable, platform-style patent portfolio.
Patent status
| Patent issue |
Commercial assessment |
| Active ingredient patents |
Hydrocodone and ibuprofen are long-established active ingredients |
| Combination-product patents |
Any original composition claims are commercially expired or immaterial to current entry |
| Formulation patents |
Immediate-release tablet formulation is readily substitutable through ANDA pathways |
| Method-of-use patents |
No known current method-of-use protection supporting meaningful market exclusivity |
| Manufacturing patents |
Process know-how may remain confidential but does not create broad product exclusivity |
| Orange Book relevance |
The product is a legacy genericized medicine rather than a patent-protected branded product |
FDA Orange Book listings determine whether an approved drug has patents or regulatory exclusivity that an ANDA applicant must address. For a mature combination such as hydrocodone/ibuprofen, the key barrier is generally not patent litigation. It is the ability to obtain approval, source controlled hydrocodone, satisfy quality requirements, and maintain reliable supply.[2]
What is the FDA regulatory status of hydrocodone/ibuprofen?
The product remains an FDA-approved prescription combination for acute pain. The FDA label limits treatment to the shortest duration consistent with the treatment objective and warns about addiction, abuse, misuse, overdose, and death.[1]
Regulatory constraints
Hydrocodone/ibuprofen is subject to several controls that materially affect its commercial profile:
- It is a Schedule II controlled substance.
- Refills are prohibited under federal law.
- Prescribing and dispensing are affected by state opioid limits and payer policies.
- The ibuprofen component limits cumulative exposure and makes prolonged use clinically unsuitable.
- FDA opioid-labeling requirements increase compliance obligations for manufacturers.
- DEA production quotas can affect active pharmaceutical ingredient and finished-dose availability.[3]
The combination is therefore less flexible commercially than a conventional noncontrolled analgesic. A manufacturer must manage both opioid regulation and NSAID safety requirements.
How many companies manufacture or market generic hydrocodone/ibuprofen?
The U.S. market has historically included multiple ANDA holders and contract manufacturers, although the active supplier set can change because of discontinuations, shortages, quota constraints, and commercial withdrawals.
Public FDA data should be used to verify the current applicant and marketing status for each strength. Generic suppliers have included large U.S. and international pharmaceutical companies across different periods, while retail availability has often depended on wholesalers and pharmacy purchasing policies rather than on the number of approved ANDAs alone.[2]
| Competitive factor |
Effect on market |
| Multiple ANDA holders |
Reduces long-term pricing power |
| Controlled-substance manufacturing |
Limits entry compared with ordinary NSAIDs |
| Small demand base |
Restricts the number of economically attractive suppliers |
| Wholesale consolidation |
Increases dependence on major distributors |
| Opioid scrutiny |
Raises compliance and monitoring costs |
| Product discontinuations |
Can create temporary supply gaps without restoring durable pricing power |
Approval count should not be treated as equivalent to active competition. Some ANDA holders may have discontinued commercial distribution, maintain limited production, or rely on third-party manufacturers.
What formulations are protected by hydrocodone/ibuprofen patents?
The commercially established formulation is an immediate-release tablet containing hydrocodone bitartrate and ibuprofen. There is no widely established extended-release, abuse-deterrent, transdermal, injectable, or long-acting hydrocodone/ibuprofen product with a comparable commercial position.
Formulation economics
The formulation has limited differentiation:
- The tablet uses widely known active ingredients.
- The product does not depend on a complex delivery device.
- Bioequivalence can be demonstrated through the ANDA pathway.
- Manufacturing can be performed by qualified solid-dose facilities.
- The ibuprofen-to-hydrocodone ratio is clinically and commercially familiar.
A new formulation could seek patent protection through modified release, abuse deterrence, reduced gastrointestinal toxicity, or alternative dosing. Such a product would need to justify development costs against a low-price generic reference product and a shrinking opioid market.
Which companies are challenging the branded product?
The commercial challenge came through generic entry rather than a major, publicly consequential Paragraph IV litigation campaign. Generic applicants could pursue ANDA approval once applicable patent and exclusivity barriers expired or became irrelevant.
Paragraph IV risk
Paragraph IV litigation is not a major current value driver for hydrocodone/ibuprofen because:
- The original product is mature.
- Generic competition is established.
- The branded product does not command significant exclusivity-based pricing.
- The principal commercial risks involve supply and regulation, not patent invalidity.
For a new branded reformulation, the analysis would change. A reformulated product with a new dosage form or abuse-deterrent claim could face Paragraph IV challenges against formulation, method-of-use, or manufacturing patents.
What patent litigation affects hydrocodone bitartrate/ibuprofen?
No active, high-value patent dispute is central to the current U.S. market for the legacy combination. The more relevant legal exposure relates to controlled-substance compliance, product liability, opioid marketing conduct, and distributor oversight.
| Legal issue |
Current commercial significance |
| Patent infringement |
Low |
| ANDA litigation |
Low for the legacy product |
| Opioid liability |
Material sector-wide risk |
| Product labeling |
Material |
| Manufacturing compliance |
Material |
| Controlled-substance diversion |
Material |
| State opioid restrictions |
Material |
| Settlement-related obligations |
Relevant to opioid manufacturers and distributors generally |
The absence of a major patent case does not eliminate legal risk. A supplier can face FDA enforcement, DEA action, civil product-liability claims, or supply-chain scrutiny even when its product is patent-free.
What is the financial trajectory for hydrocodone/ibuprofen?
Product-level revenue is generally not disclosed by generic manufacturers. The financial trajectory is therefore best assessed through market structure rather than through a separately reported brand sales series.
Revenue trajectory
| Period |
Financial profile |
| Initial branded period |
Premium pricing supported by brand recognition and limited competition |
| Early generic entry |
Rapid price compression and share migration |
| Mature generic period |
Low unit economics with volume dependent on prescribing and supply |
| Current market |
Limited branded value; modest generic revenue opportunity |
| Long-term outlook |
Stable-to-declining demand, punctuated by shortages or supplier exits |
Several forces suppress revenue:
- Lower opioid prescribing after 2010s prescribing reforms.
- Greater use of acetaminophen, NSAIDs, regional anesthesia, and multimodal pain management.
- State limits on initial opioid prescriptions.
- Prescription-monitoring programs.
- Insurer and pharmacy controls.
- Public scrutiny of opioid products.
- The short authorized duration of therapy.
- Low generic reimbursement.
The combination can retain demand in acute dental, postoperative, orthopedic, and injury-related pain. That demand does not generally support high growth because treatment courses are brief and prescribers have alternatives.
How does hydrocodone/ibuprofen compare with hydrocodone/acetaminophen?
Hydrocodone/acetaminophen has historically had broader market recognition and a larger commercial footprint. Hydrocodone/ibuprofen differentiates itself through NSAID anti-inflammatory activity but carries ibuprofen-specific gastrointestinal and renal risks.
| Factor |
Hydrocodone/ibuprofen |
Hydrocodone/acetaminophen |
| Opioid component |
Hydrocodone |
Hydrocodone |
| Nonopioid component |
Ibuprofen |
Acetaminophen |
| Anti-inflammatory activity |
Stronger |
Limited |
| Key nonopioid toxicity |
Gastrointestinal, renal, cardiovascular, bleeding |
Hepatic toxicity at excessive exposure |
| Brand recognition |
Lower |
Historically higher |
| Generic competition |
Established |
Established |
| Main commercial use |
Short-term acute pain |
Short-term acute pain |
| Strategic market position |
Narrower niche |
Broader historical use |
Neither product has a strong patent-based growth profile. Competition is increasingly from nonopioid treatment pathways rather than from one opioid combination against another.
What generic entry risks exist?
Generic entry risk to the original brand is already realized. The remaining risk is price and volume erosion among generic suppliers.
Generic launch scenarios
| Scenario |
Likely market effect |
| New generic entrant |
Lower average selling price and share dilution |
| Supplier withdrawal |
Temporary shortage and possible volume transfer to remaining suppliers |
| DEA quota tightening |
Reduced availability and higher procurement friction |
| Opioid prescribing decline |
Lower total market volume |
| Manufacturing disruption |
Short-term price and share volatility |
| New nonopioid guideline adoption |
Structural demand erosion |
The market can experience temporary supply tightness without becoming an attractive branded market. Shortages may improve utilization for incumbent generic suppliers, but the effect is usually episodic and constrained by regulation.
How strong is the patent estate for hydrocodone/ibuprofen?
The patent estate is weak from an investment perspective. Its relevant characteristics are:
- No durable composition-of-matter protection.
- No meaningful current Orange Book exclusivity thesis.
- No complex device or biologic manufacturing barrier.
- Limited formulation differentiation.
- Mature active ingredients.
- Established generic substitution.
- Low probability that litigation will restore premium pricing.
The stronger barriers are operational. A capable supplier needs DEA registration, controlled-substance compliance systems, qualified manufacturing, validated analytical methods, reliable API access, and distribution relationships. These barriers can deter small entrants but do not create monopoly economics.
What licensing deals affect the product?
No major current licensing deal is central to the value of legacy hydrocodone/ibuprofen. The original brand changed hands within the historical pharmaceutical commercialization chain, but current generic economics are usually governed by contract manufacturing, supply agreements, and ANDA ownership rather than by high-value royalty licenses.
A licensing transaction involving this product would likely be structured around:
- ANDA transfer;
- contract manufacturing;
- controlled-substance API supply;
- regional distribution;
- portfolio acquisition;
- commercialization rights tied to a broader generic platform.
The low price and regulatory burden make a standalone royalty-bearing license less attractive than a bundled generic portfolio transaction.
What is the competitive outlook and revenue exposure?
The competitive outlook is mature and defensive. The product can generate incremental revenue for a generic manufacturer with excess solid-dose capacity, but it is unlikely to be a material growth platform unless a supplier benefits from a temporary shortage or adds the product to a broader hospital and retail portfolio.
Revenue exposure is highest for companies with:
- Existing Schedule II manufacturing infrastructure;
- Low-cost tablet capacity;
- Established opioid distribution controls;
- Hospital and dental-channel access;
- A broad generic analgesic portfolio;
- The ability to tolerate low margins.
Revenue exposure is lowest for companies seeking high-growth branded assets, biologic-like barriers, or substantial patent-adjusted pricing power.
Key Takeaways
- Hydrocodone bitartrate/ibuprofen is a mature FDA-approved opioid/NSAID combination marketed originally as Vicoprofen.
- The standard U.S. product contains hydrocodone bitartrate 7.5 mg and ibuprofen 200 mg per tablet.
- Brand and regulatory exclusivity have expired, and generic competition is established.
- Patent litigation is not the central commercial issue.
- The strongest barriers are controlled-substance regulation, DEA quotas, manufacturing compliance, and supply reliability.
- Product-level revenue is generally not separately disclosed by generic manufacturers.
- Long-term demand is constrained by opioid stewardship, short treatment duration, payer controls, and nonopioid alternatives.
- The asset has low patent strength, low branded investment value, and modest potential as a generic portfolio product.
- Temporary shortages can improve incumbent supplier economics but do not create durable exclusivity.
- The principal commercial thesis is operational execution, not patent protection.
FAQs
Is hydrocodone bitartrate/ibuprofen still available?
Generic hydrocodone/ibuprofen has been marketed in the United States, but product availability can vary by manufacturer, wholesaler, pharmacy, and controlled-substance supply conditions.
Is hydrocodone/ibuprofen stronger than hydrocodone/acetaminophen?
The opioid component is the same when the hydrocodone dose is equivalent. The clinical difference comes from the nonopioid component: ibuprofen has anti-inflammatory activity, while acetaminophen does not have comparable anti-inflammatory effects.
Does hydrocodone/ibuprofen have Orange Book patents?
The legacy product does not present a commercially meaningful active-patent exclusivity position. The FDA Orange Book remains the authoritative source for current patent and exclusivity listings.[2]
Can a company launch a new hydrocodone/ibuprofen formulation?
A company could develop a new formulation, but it would need to establish FDA approval, demonstrate safety and efficacy or bioequivalence as applicable, address controlled-substance requirements, and justify development costs against low-priced generics.
Is hydrocodone/ibuprofen an attractive pharmaceutical acquisition target?
As a standalone product, it has limited strategic value. It may be attractive as part of a larger generic portfolio where the buyer has controlled-substance infrastructure, manufacturing capacity, and distribution scale.
References
-
U.S. Food and Drug Administration. (n.d.). Vicoprofen: Hydrocodone bitartrate and ibuprofen tablets, prescribing information. Drugs@FDA.
-
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.
-
Drug Enforcement Administration. (2023). Aggregate production quotas for controlled substances. U.S. Department of Justice.
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U.S. Food and Drug Administration. (2016). FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose, and death. U.S. Department of Health and Human Services.
-
Centers for Disease Control and Prevention. (2022). CDC clinical practice guideline for prescribing opioids for pain. U.S. Department of Health and Human Services.
