HYDROCODONE BITARTRATE AND ASPIRIN Drug Patent Profile

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Which patents cover Hydrocodone Bitartrate And Aspirin, and when can generic versions of Hydrocodone Bitartrate And Aspirin launch?

Hydrocodone Bitartrate And Aspirin is a drug marketed by Lgm Pharma and is included in one NDA.

The generic ingredient in HYDROCODONE BITARTRATE AND ASPIRIN is aspirin; hydrocodone bitartrate. There is one drug master file entry for this compound. Additional details are available on the aspirin; hydrocodone bitartrate profile page.

Summary for HYDROCODONE BITARTRATE AND ASPIRIN

US Patents:	0
Applicants:	1
NDAs:	1
Patent Applications:	9
DailyMed Link:	HYDROCODONE BITARTRATE AND ASPIRIN at DailyMed

US Patents and Regulatory Information for HYDROCODONE BITARTRATE AND ASPIRIN

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

Hydrocodone Bitartrate and Aspirin Market Dynamics, Patent Status, and Financial Trajectory

Last updated: August 29, 2026

Hydrocodone bitartrate and aspirin is a legacy immediate-release opioid combination with limited current commercial relevance in the United States. The product’s market has contracted because of opioid prescribing controls, product discontinuations, generic substitution, abuse-deterrent competition, and the displacement of aspirin-containing combinations by hydrocodone-acetaminophen products. No active innovator exclusivity or meaningful standalone branded revenue base supports the combination today. Its commercial value is concentrated in low-margin generic supply, institutional contracts, and residual demand rather than innovation-driven pricing.

What is hydrocodone bitartrate and aspirin used for?

Hydrocodone bitartrate and aspirin combines an opioid analgesic with a non-opioid analgesic. Hydrocodone acts primarily through mu-opioid receptors, while aspirin provides analgesic and anti-inflammatory activity through cyclooxygenase inhibition.

The product historically targeted moderate to moderately severe pain. It was supplied as an oral tablet, generally in fixed-dose combinations containing hydrocodone bitartrate and aspirin. Product labels warned of respiratory depression, sedation, gastrointestinal bleeding, renal risks, dependence, and overdose.[1]

The combination differs from the more commercially important hydrocodone-acetaminophen segment. Acetaminophen combinations became the dominant hydrocodone formulation because they avoided aspirin-related gastrointestinal bleeding and platelet-inhibition concerns. That shift reduced the clinical and commercial role of hydrocodone-aspirin tablets.

How does hydrocodone-aspirin compare with hydrocodone-acetaminophen?

Attribute	Hydrocodone bitartrate and aspirin	Hydrocodone-acetaminophen
Main historical use	Acute pain	Acute pain
Opioid component	Hydrocodone bitartrate	Hydrocodone bitartrate
Non-opioid component	Aspirin	Acetaminophen
Bleeding risk	Higher because aspirin inhibits platelet function	Lower platelet effect
Liver toxicity concern	Lower than acetaminophen combinations	Acetaminophen dose limits are material
Current commercial footprint	Very limited	Larger generic market
Abuse-deterrent innovation	Little current activity	Some branded and reformulated activity
Biosimilar exposure	None	None
Prescription classification	Schedule II in the U.S.	Schedule II in the U.S.

Hydrocodone-containing products were placed in Schedule II under the federal Controlled Substances Act in 2014, ending the less restrictive Schedule III treatment that previously applied to many hydrocodone combination products.[2]

What is the current FDA and Orange Book status?

The commercial status of hydrocodone bitartrate and aspirin is primarily generic and legacy-oriented. The FDA’s current drug databases and Orange Book framework distinguish between approved products, discontinued products, and products with active therapeutic-equivalence listings.[3]

The exact hydrocodone-aspirin combination has no meaningful current brand franchise comparable with Vicodin, Norco, or generic hydrocodone-acetaminophen. Historical products and generic labels may remain in regulatory records even when commercial distribution is minimal or discontinued.

Regulatory issue	Current assessment
FDA pathway	Historically approved prescription drug products; current supply is primarily generic or legacy
Controlled-substance schedule	Schedule II
Current branded growth product	None with material market visibility
Orange Book patent protection	No commercially significant active innovator patent estate identified for the legacy combination
New-drug exclusivity	Expired
Pediatric exclusivity	Not commercially relevant
Biosimilar pathway	Not applicable
Generic substitution	The principal competitive mechanism
REMS exposure	Hydrocodone opioid products are subject to FDA opioid risk-management requirements

The FDA’s opioid labeling and risk-management changes have increased compliance obligations for manufacturers, prescribers, distributors, and pharmacies.[4] These requirements raise operating friction without creating meaningful pricing power for a mature hydrocodone-aspirin product.

What patents protect hydrocodone bitartrate and aspirin?

No active composition-of-matter patent is expected to protect the legacy hydrocodone-aspirin combination. Hydrocodone and aspirin are both long-established pharmaceutical ingredients, and fixed-dose oral combinations of this type entered the market decades ago.

Patent estate assessment

Patent category	Commercial relevance
Hydrocodone composition patents	Expired
Aspirin composition patents	Expired
Fixed-dose combination patents	Expected to be expired
Immediate-release tablet patents	Expired or nonblocking
Abuse-deterrent formulation patents	Limited relevance to conventional hydrocodone-aspirin tablets
Method-of-use patents	No material current exclusivity identified
Manufacturing patents	Potentially applicable at the supplier level but unlikely to block generic production
Orange Book-listed patents	No significant active estate identified for the legacy product

The absence of a meaningful patent barrier means that a manufacturer generally competes through an abbreviated new drug application, manufacturing scale, controlled-substance quota access, supply reliability, and contracting. A Paragraph IV strategy has little economic value where no active listed patent presents a credible launch obstacle.

When did hydrocodone bitartrate and aspirin lose exclusivity?

The product lost practical exclusivity long before the current generic pharmaceutical market developed. The relevant commercial loss occurred through the expiration of early hydrocodone and fixed-dose combination patents, followed by the arrival of multiple generic manufacturers.

Because the product is a mature small-molecule combination, the key exclusivity dates are historical rather than forward-looking:

Exclusivity type	Status
New chemical entity exclusivity	Expired decades ago
Original formulation protection	Expired
Fixed-dose combination patent protection	Expired or commercially nonblocking
Regulatory orphan exclusivity	Not applicable
Pediatric exclusivity	Not material
Current market exclusivity	None identified

A future generic launch would therefore not depend on an innovator patent challenge. It would depend on FDA approval, DEA quota, commercial demand, and the willingness of wholesalers and pharmacies to carry the product.

Are there Paragraph IV challenges or generic litigation?

No major current Paragraph IV litigation is associated with hydrocodone bitartrate and aspirin as a legacy combination. The product’s patent profile does not support sustained patent litigation comparable with protected branded medicines.

Litigation profile

The more important legal risks arise from opioid distribution and prescribing litigation rather than patent litigation. Relevant risk categories include:

• Controlled-substance diversion investigations.
• Distributor and manufacturer compliance actions.
• State opioid settlement obligations.
• False Claims Act or marketing claims.
• Failure-to-monitor controlled-substance orders.
• Product liability claims involving respiratory depression, dependence, and overdose.

Large opioid settlements have altered the economics of the entire hydrocodone market. Purdue Pharma’s bankruptcy and opioid-related settlements involving major manufacturers and distributors have increased legal reserves and compliance costs across the sector.[5]

For a generic hydrocodone-aspirin supplier, litigation exposure can exceed the value of the product’s annual sales if manufacturing, distribution, or pharmacovigilance controls are weak.

What formulations are protected by patents?

The conventional hydrocodone-aspirin tablet has little apparent formulation differentiation. The main technical opportunities would involve:

• Abuse-deterrent release mechanisms.
• Modified-release hydrocodone delivery.
• Reduced gastrointestinal exposure.
• Alternative dosage forms.
• Tamper-resistant tablets.
• Lower-dose formulations.
• Combination products with improved tolerability.

These approaches face a difficult commercial calculation. Abuse-deterrent technology can generate patent protection, but hydrocodone-aspirin demand is too limited to support substantial formulation investment unless the product is part of a broader opioid platform.

A conventional immediate-release tablet is easier to manufacture but has limited pricing power. The manufacturing barriers are operational rather than patent-based.

How strong is the patent estate for hydrocodone bitartrate and aspirin?

The patent estate is weak from an innovator perspective and largely irrelevant as a barrier to generic entry.

Strength factor	Assessment
Composition-of-matter protection	None expected
Remaining patent term	No material term identified
Formulation differentiation	Low
Method-of-use protection	Low
Manufacturing complexity	Low to moderate
Controlled-substance supply barriers	Moderate
Regulatory compliance burden	High
Generic entry barrier	Low on patents; moderate operationally

Controlled-substance manufacturing introduces practical barriers that do not appear in a conventional small-molecule patent review. Manufacturers need DEA registration, quota management, security controls, inventory reconciliation, suspicious-order monitoring, and compliant distribution arrangements.[6]

These controls can limit the number of active suppliers even when patents do not.

What is the financial trajectory for hydrocodone bitartrate and aspirin?

No public company reports standalone revenue for hydrocodone bitartrate and aspirin in a way that permits a reliable product-level financial series. The product is generally included within broader generic opioid, analgesic, or controlled-substance reporting.

The financial trajectory is therefore best assessed through market structure:

1. Historical branded sales declined after generic entry.
2. Generic prices fell as multiple suppliers entered.
3. Hydrocodone prescribing contracted after regulatory and clinical restrictions.
4. Aspirin-containing combinations lost share to acetaminophen products.
5. Opioid litigation and compliance expenses reduced net profitability.
6. Current demand is concentrated in residual prescriptions and institutional channels.

Revenue and margin outlook

Financial driver	Direction	Impact
Unit demand	Down over the long term	Shrinks market volume
Average selling price	Down or volatile	Limits revenue growth
Generic competition	High	Compresses gross margin
Controlled-substance compliance	Cost increase	Reduces operating margin
Product shortages	Intermittent upward pricing pressure	Can temporarily improve revenue
Branded pricing power	Minimal	No durable premium
R&D contribution	Minimal	No innovation-led expansion
Litigation expense	Elevated sector-wide	Reduces net earnings
Hospital and wholesaler contracting	Important	Rewards supply reliability

The product can remain economically viable for a low-cost manufacturer with existing opioid infrastructure. It is unlikely to justify a dedicated commercial organization, new clinical trials, or major formulation investment.

Which companies are competing in the hydrocodone-aspirin market?

Competition is primarily among generic manufacturers and contract suppliers. The relevant competitive set can change because companies periodically discontinue controlled-substance products, reduce quotas, or exit low-margin formulations.

The market structure typically includes:

• Large generic manufacturers with established DEA infrastructure.
• Specialty controlled-substance manufacturers.
• Contract development and manufacturing organizations.
• Legacy label holders with limited direct commercial activity.
• Wholesalers and institutional suppliers.

Competition is determined less by brand recognition than by:

• FDA-approved manufacturing capacity.
• DEA quota availability.
• Reliable active pharmaceutical ingredient supply.
• Wholesaler access.
• Controlled-substance compliance history.
• Ability to maintain inventory during shortages.

No major licensing transaction or strategic alliance is publicly associated with hydrocodone bitartrate and aspirin as a standalone product. Licensing economics are more likely to arise at the manufacturing or portfolio level than through rights to the legacy combination itself.

What generic entry risks exist for hydrocodone bitartrate and aspirin?

Patent-based generic entry risk is already realized because the product is mature and lacks meaningful exclusivity. The main commercial risk is further erosion of a small residual market.

Generic launch scenarios

Scenario	Market effect
New approved generic enters	Lower prices and reduced share for incumbent suppliers
Existing supplier exits	Temporary shortage and short-term price improvement
DEA quota tightens	Lower available volume and increased supply risk
Hospital demand falls	Further reduction in addressable market
Opioid policy tightens	Lower prescription volume
Alternative analgesics gain share	Continued displacement
Manufacturing disruption occurs	Short-term supply imbalance

A new entrant would have limited upside unless it secured a supply contract or entered during a shortage. The primary risks are low market size, low prices, controlled-substance inventory requirements, and liability exposure.

What regulatory changes affect the market?

The FDA and DEA regulatory environment remains the central market variable. Hydrocodone products face prescribing controls, labeling requirements, abuse-risk concerns, and supply-chain scrutiny.

The FDA has also emphasized opioid stewardship, appropriate prescribing, postmarket surveillance, and risk communication. CDC prescribing guidance has reduced the likelihood that older opioid combinations will regain broad primary-care use.[7]

Aspirin adds a separate safety concern because it can increase gastrointestinal bleeding risk and interact with anticoagulant and antiplatelet therapies. This reduces attractiveness for patients with chronic pain or elevated bleeding risk.

How does hydrocodone bitartrate and aspirin compare with competing analgesics?

Product class	Commercial position	Key advantage	Key weakness
Hydrocodone-aspirin	Legacy niche	Established analgesic activity	Bleeding risk and weak market demand
Hydrocodone-acetaminophen	Larger generic segment	Familiar prescribing base	Acetaminophen hepatotoxicity limits
Oxycodone-acetaminophen	Established opioid segment	Higher perceived potency	Strong abuse and regulatory scrutiny
Tramadol combinations	Broader lower-intensity use	Less restrictive scheduling historically	Lower analgesic potency and variable response
NSAIDs	Large non-opioid market	No opioid dependence risk	Gastrointestinal, renal, and cardiovascular risks
Non-opioid multimodal therapy	Expanding clinical role	Reduces opioid exposure	May provide less relief for severe acute pain

Hydrocodone-aspirin is disadvantaged by both safety and market positioning. It lacks the commercial familiarity of hydrocodone-acetaminophen and lacks the growth profile of newer non-opioid pain-management approaches.

What is the geographic coverage and manufacturing outlook?

The product is primarily a U.S. regulatory and commercial issue because hydrocodone controls vary substantially by jurisdiction. International markets may use different hydrocodone formulations, opioid schedules, and analgesic combinations.

In the United States, manufacturing is feasible but requires:

• FDA-compliant drug manufacturing.
• DEA registration and quota allocation.
• Secure storage and shipment.
• Controlled-substance recordkeeping.
• Qualified API suppliers.
• Distributor monitoring.
• Pharmacovigilance and adverse-event reporting.

Manufacturing IP is unlikely to block production of a conventional tablet. The more significant barriers are API sourcing, controlled-substance approvals, quality systems, and commercial access.

Key Takeaways

• Hydrocodone bitartrate and aspirin is a mature, low-growth opioid combination with limited current commercial visibility.
• Its original composition and formulation protections have expired or are commercially nonblocking.
• No material active innovator exclusivity or current patent estate has been identified for the legacy combination.
• Paragraph IV litigation is not a central market issue.
• Generic supply, DEA quota, manufacturing compliance, and wholesaler access determine commercial viability.
• Hydrocodone-acetaminophen products have stronger market relevance and displaced much of the aspirin combination’s demand.
• No reliable standalone public revenue series exists for hydrocodone bitartrate and aspirin.
• Long-term revenue is likely declining, with short-term volatility caused by shortages, supplier exits, and regulatory changes.
• The product has no biosimilar risk because it is a conventional small-molecule drug.
• Investment value is limited unless the product is bundled into a broader controlled-substance manufacturing or supply platform.

FAQs

Is hydrocodone bitartrate and aspirin still commercially available?

Availability is limited and may vary by manufacturer, pharmacy, and state. Legacy approvals and historical labels do not establish continuous commercial distribution.

Is hydrocodone bitartrate and aspirin stronger than hydrocodone-acetaminophen?

The opioid component is the same, but clinical potency depends on the hydrocodone dose, patient factors, and formulation. The non-opioid components have different safety profiles rather than a simple strength hierarchy.

Does aspirin in the combination increase bleeding risk?

Yes. Aspirin inhibits platelet aggregation and can increase gastrointestinal and surgical bleeding risk, especially with anticoagulants, other antiplatelet drugs, alcohol use, or a history of ulcers.

Can a generic manufacturer obtain exclusivity for hydrocodone-aspirin?

A new generic manufacturer generally would not receive meaningful market exclusivity solely by entering a mature, previously approved combination. Exclusivity could arise only through a qualifying new formulation, clinical innovation, or other statutory pathway.

Is hydrocodone bitartrate and aspirin covered by the Medicare Part D market?

Coverage depends on the specific product, formulary, National Drug Code, plan rules, and whether the product is actively marketed. Generic coverage is generally subject to controlled-substance formulary and utilization controls.

References

1. U.S. Food and Drug Administration. (n.d.). Hydrocodone bitartrate and aspirin prescribing information. FDA Drug Database.

2. Drug Enforcement Administration. (2014). Final rule: Placement of hydrocodone combination products into Schedule II. U.S. Department of Justice.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. FDA.

4. U.S. Food and Drug Administration. (2022). Opioid analgesic risk evaluation and mitigation strategy. FDA.

5. U.S. Department of Justice. (2022). Opioid litigation and controlled-substance enforcement actions. U.S. Department of Justice.

6. Drug Enforcement Administration. (2024). Controlled substances ordering system and production quota regulations. U.S. Department of Justice.

7. Centers for Disease Control and Prevention. (2022). CDC clinical practice guideline for prescribing opioids for pain. U.S. Department of Health and Human Services.