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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 are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; hydrocodone bitartrate profile page.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for HYDROCODONE BITARTRATE AND ASPIRIN?
- What are the global sales for HYDROCODONE BITARTRATE AND ASPIRIN?
- What is Average Wholesale Price for HYDROCODONE BITARTRATE AND ASPIRIN?
Summary for HYDROCODONE BITARTRATE AND ASPIRIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
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 | ⤷ 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 |
Executive summary
Hydrocodone bitartrate plus aspirin is an opioid–analgesic combination with a tightly constrained modern commercialization profile due to opioid risk controls and the long-tail of generic availability. From an investment standpoint, the dominant drivers are (1) remaining patent and exclusivity coverage for specific NDCs and dosage forms, (2) FDA/DEA regulatory posture for opioid labeling and REMS-era controls, (3) litigation and state-led opioid risk exposure tied to branded opioid supply chains, and (4) reimbursement and managed-care formulary access for generic equivalents. For investors, the risk-return profile is typically less “IP-led” than “regulatory-and-distribution-led” unless a company owns protection for a specific formulation, bioavailability feature, or unique dosage strength.
Because no specific product label (brand vs generic), strength (e.g., fixed mg ratios), dosage form (tablet vs other), NDC, market geography, or patent family detail is provided, a complete, accurate fundamentals assessment tied to an investable IP and regulatory status cannot be produced.
If you are evaluating an investment scenario for a specific marketed product (one NDC/strength/dosage form), the analysis must be anchored to that exact product’s Orange Book entries, patent lists, FDA approval history, and any active Paragraph IV or opioid litigation tied to the NDA holder or marketer. Without those identifiers, the investment conclusion would not be reliable.
What patents protect hydrocodone bitartrate and aspirin combinations?
Featured-snippet answer: Patent coverage for hydrocodone bitartrate plus aspirin, where it exists today, is usually limited to specific dosage forms, formulation features (e.g., controlled dissolution), and method-of-manufacture or method-of-use claims rather than broad active-ingredient composition claims, because the underlying actives are long out of new-drug exclusivity.
What typically remains patentable in hydrocodone/aspirin fixed-dose products
- Formulation patents
- Release-rate or dissolution-control of hydrocodone in immediate-release tablets
- Physical stabilization of the hydrocodone salt in the presence of aspirin and excipients
- Bioavailability-improvement claims tied to particle size, granulation, or compression parameters
- Device and pack patents
- Packaging for tamper resistance where applicable to the specific NDA
- Manufacturing method patents
- Granulation, mixing order, compression conditions, or blending uniformity methods
- Method-of-use patents
- Specific dosing regimens, special populations, or combined analgesic regimens
Which jurisdictions matter for exclusivity and enforcement
- US: Orange Book patent listings for the specific NDA determine enforcement leverage versus generics
- EU/UK: national EP validation and local SPC status if any
- Canada: Canadian Patent Register status for the exact medicinal ingredient + dosage form
Investment implication
Unless the investor controls or licenses a current, listed US patent for a specific NDC or holds a strong formulation patent family with clear claim coverage, the commercial ceiling tends to be set by generic competition rather than exclusivity.
When does hydrocodone bitartrate and aspirin lose exclusivity?
Featured-snippet answer: Exclusivity timelines (5-year/3-year/OTC etc.) and patent expiration vary by specific NDA and filing date. For fixed-dose hydrocodone/aspirin combinations, most “new product” exclusivity has elapsed, making generic entry timing mostly a function of Orange Book patents tied to particular NDCs.
How to structure exclusivity risk for investment decisions
- Step 1: identify the exact NDA and NDC(s) for the product in question
- Step 2: map
- listed patents by US category (composition, formulation, method of use, manufacturing)
- expiration dates and any terminal disclaimers
- Step 3: check for active Paragraph IV litigations (if any)
- Step 4: confirm whether any pediatric exclusivity or other extensions apply
Where exclusivity often ends
- Active-ingredient era exclusivity typically ends years before modern opioid risk controls shape labeling and distribution constraints
- Ongoing coverage, when present, is typically for formulation and manufacturing methods tied to a particular NDC strength
How many patents cover hydrocodone bitartrate and aspirin products on the Orange Book?
Featured-snippet answer: Patent counts are NDA-specific; in many older opioid combination assets, Orange Book listings decline to a small set tied to formulation/manufacturing and may have already expired for many NDCs.
What to expect in a typical Orange Book snapshot
- Multiple listed patents near the 1 to 3-year mark before generic launch risk
- Patent families spanning composition + formulation, but the enforceable set at present is often reduced to one or two claims
Investment implication
For investment underwriting, the key metric is not “how many patents exist,” but “how many are still listed and unexpired as of today for the exact NDC strength/dosage form.”
What generic entry risks exist for hydrocodone bitartrate and aspirin?
Featured-snippet answer: Generic entry risk is generally high for older fixed-dose opioid combinations because the actives are established and manufacturing is feasible. The practical risk is driven by whether any remaining unexpired Orange Book patents cover the specific NDC strength.
Paragraph IV risks and signaling
- If an ANDA files a Paragraph IV certification against listed patents, it creates
- potential 30-month stay (if triggered)
- litigation timeline risk and settlement uncertainty
- If no unexpired listed patents remain, generics may launch without Paragraph IV leverage
Commercial downside scenarios
- Price erosion to low single-digit to mid double-digit percent margins depending on payer mix
- Loss of formulary access for specific strengths if cheaper equivalents gain preference
- DEA and opioid distribution scrutiny affecting channel partners, not just the product
What patent litigation affects hydrocodone bitartrate and aspirin in the US?
Featured-snippet answer: Litigation typically clusters around ANDA Paragraph IV challenges and, for branded opioid products, around broader opioid-related liability. The litigation profile is product-specific and often tied to the NDA holder/labeler.
Litigation types that matter for investors
- Hatch-Waxman (ANDA/Paragraph IV)
- Claim construction and infringement of formulation/manufacturing method patents
- Settlement agreements that define “carve-out” strengths and launch dates
- Opioid liability
- Distribution model scrutiny
- Allegations tied to marketing and promotion practices
- State attorney general settlements and consent decrees
Investment implication
For a fixed-dose opioid combination, the expected value of cash flows can be dominated by opioid-risk legal exposure where the company has branded-market history and distribution footprint.
How does hydrocodone bitartrate and aspirin compare with hydrocodone combination opioids (e.g., acetaminophen) for market and IP value?
Featured-snippet answer: Compared with hydrocodone/acetaminophen, hydrocodone/aspirin products face additional clinical and labeling constraints related to aspirin adverse effects (GI bleeding risk, renal/hepatic considerations). Commercial value tends to be more niche unless an insurer favors specific formulations by cost.
Competitive landscape drivers
- Payer preference and step therapy
- Safety and tolerability in chronic-use populations
- Generic availability and substitution policies
- Product-level handling and storage considerations for opioid distribution
Investment implication
Even with IP, differentiation is typically limited once generics exist. The best investment setups are those with (a) active, enforceable patent coverage on a still-protected NDC or (b) a distribution or contract position that protects volume despite generics.
What is the Orange Book status of hydrocodone bitartrate and aspirin?
Featured-snippet answer: Orange Book status is defined per NDA and NDC strength. Without a specific NDA/NDC, a correct status (active vs expired patents; tentative approvals; listed expiration) cannot be stated.
What investors need from an Orange Book pull (per NDA/NDC)
- NDA number and labeler
- Patent list with
- patent number
- listed drug substance/product
- expiration date
- Orange Book patent “type” (A/B/C/D or other listed categories)
- Any approved supplement that changes dosage form or formulation
What formulations are protected by patents for hydrocodone bitartrate and aspirin tablets?
Featured-snippet answer: When protected, formulation patents usually claim specific dissolution characteristics or manufacturing uniformity rather than generic “hydrocodone + aspirin” combinations.
Formulation elements that often appear in claim sets
- Granulation technique
- Excipient system balancing aspirin stability and hydrocodone salt stability
- Compression parameters controlling dissolution and content uniformity
- Coating or surface treatment (if any)
- Storage stability methods and acceptance criteria
Investment implication
A formulation patent only matters if
- it is still unexpired for the exact NDC,
- the generic manufacturing process plausibly infringes,
- and enforcement is practical against at-risk ANDA applicants.
How strong is the patent estate for hydrocodone bitartrate and aspirin?
Featured-snippet answer: Patent strength is generally moderate to low for older opioid combination products because remaining enforceable rights are narrower (formulation/manufacturing/method-of-use) and many claims have aged out.
Strength scoring framework (for NDA-specific estates)
- Breadth: claim scope across excipient systems, process ranges, and dose ratios
- Remaining life: unexpired time against generic entry windows
- Enforcement history: prior settlements or consistent court outcomes (if any)
- Design-around: freedom for generics to change process/excipients to avoid infringement
- Claim validity risk: obviousness and lack of written description issues
Investment implication
A “strong” estate is one that still covers a commercially meaningful fraction of NDC volume with enforceable, non-trivially different claims.
What FDA regulatory status applies to hydrocodone bitartrate and aspirin (approval pathway and labeling controls)?
Featured-snippet answer: Hydrocodone-containing products are subject to opioid prescribing and controlled substance requirements, with labeling and distribution controls that can affect prescriber adoption and supply chain risk.
US regulatory items that influence fundamentals
- Controlled substance status and DEA registration requirements for distributors and pharmacies
- Labeling restrictions on use and dosage; contraindications and warnings
- Distribution oversight and risk mitigation practices
- Postmarketing requirements tied to safety signals (when applicable to the specific NDA)
Investment implication
Even with IP, demand can be constrained by prescriber caution and channel policy. Safety and compliance costs can rise independent of patent status.
What commercial metrics drive investment value for hydrocodone bitartrate and aspirin?
Featured-snippet answer: For mature opioid combination products, investment value is typically driven by volume retention in a generic environment, payer coverage, and channel reliability, not by patent-led premium pricing.
Key commercial drivers
- TRx and NBRx by strength and dosage form
- Channel inventory cycles and wholesaler buying patterns
- Net price vs. list price (rebates, chargebacks, contract discounts)
- Formulary status and step edit policies
- Competitive set substitution rates (OTC/in-class alternatives and other hydrocodone combinations)
Supply chain drivers
- Product availability and batch release timelines
- Regulatory compliance in manufacturing (FDA inspections and remediation costs)
- DEA compliance burden and distributor monitoring requirements
What settlement agreements matter for hydrocodone bitartrate and aspirin generic launches?
Featured-snippet answer: Settlements matter when the company controls still-listed Orange Book patents on a specific NDC. They can allocate market entry timing and include non-expansion or “carve-out” terms.
Settlement terms investors watch
- Launch date commitments
- Product carve-outs by NDC strength
- Stipulated damages or compliance covenants
- Dismissal scope of claims and waiver of future infringement theories
Investment implication
The practical outcome is often a constrained generic entry that preserves volume for a period. Without NDA/NDC-specific litigation identifiers, the settlement landscape cannot be mapped accurately.
Key Takeaways
- Hydrocodone bitartrate and aspirin is a mature opioid combination where fundamentals are usually constrained by generic competition and opioid regulation rather than strong, long-running IP.
- The decisive investment variables are NDA/NDC-specific: remaining Orange Book patent life, unexpired enforceable claims, and any active Paragraph IV litigation tied to those exact strengths.
- Commercial value is typically driven by payer formulary position, price erosion, and channel reliability under DEA-controlled distribution, with legal exposure from broader opioid-related litigation when the company has a branded legacy footprint.
- A correct investment scenario requires product-level anchoring to Orange Book and FDA labeling for the exact marketed strength and dosage form; absent those identifiers, a complete and accurate assessment cannot be produced.
FAQs
Is hydrocodone bitartrate and aspirin mainly a generic market or still brand-protected?
What NDC-specific patents most affect generic launch timing for hydrocodone/aspirin tablets?
How do Paragraph IV challenges typically influence pricing and volume for opioid combination generics?
Do formulation changes (different excipients or compression parameters) avoid infringement for opioid combination products?
What regulatory or DEA distribution factors can reduce demand even after patent expiration?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
- FDA. Drug Applications and Databases. US FDA.
- FDA. Controlled Substances Program. US FDA.
- U.S. Patent and Trademark Office (USPTO). Orange Book patent listing fundamentals and Hatch-Waxman overview (background materials). USPTO.
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