# United States Patent 9,682,075: Oxycodone Abuse-Deterrent Formulation Scope, Expiration, and Competitive Patent Landscape
US Patent No. 9,682,075 protects a specific extended-release oxycodone particle platform using waxes and a high concentration of fatty acids. Its strongest protection covers multiparticulate formulations in which oxycodone is incorporated into approximately 200-400 micron particles, the fatty-acid content is 42%-69% by weight, and the formulation maintains extended release after mechanical crushing. The patent is associated with Collegium Pharmaceutical's DETERx technology used in Xtampza ER.
The patent does not cover every abuse-deterrent oxycodone formulation. Infringement generally requires alignment with the claimed particle composition, fatty-acid range, particle-size range, release profile, and tamper-resistance characteristics.
What does US Patent 9,682,075 protect?
US 9,682,075 protects pharmaceutical compositions and related methods involving abuse-deterrent oxycodone particles. The independent claims are claim 1, covering the composition; claim 9, covering treatment of pain; and claim 10, covering manufacture.
| Claim |
Subject matter |
Principal limitations |
| 1 |
Pharmaceutical composition |
Oxycodone or salt; wax or wax-like material; fatty acid at 42%-69% by particle weight; particle D[0.5] of about 200-400 microns; 6-24-hour release; sustained release after crushing |
| 9 |
Method of treating pain |
Administration of the claimed particle composition; oxycodone in a solid dispersion or solid solution |
| 10 |
Manufacturing method |
Dispersing or dissolving the drug in wax material and forming particles of about 200-400 microns |
| 2 |
Particle morphology |
Substantially spherical particles |
| 3 |
Drug-fatty-acid interaction |
Ionic interaction between oxycodone and fatty acid |
| 4-5 |
Fatty-acid selection |
Listed fatty acids, with myristic acid specifically claimed |
| 6-7 |
Wax selection |
Listed waxes, with beeswax and carnauba wax specifically claimed |
| 8 |
Narrow composition |
Oxycodone, beeswax, carnauba wax, and myristic acid |
| 11 |
Manufacturing process |
Spinning-disc atomization |
| 12-13 |
Narrow particle size |
About 250-400 microns |
The claims use "comprising," an open-ended transition. A formulation can therefore contain additional excipients, coatings, fillers, stabilizers, or other components while remaining within the literal scope if the required elements are present.
What technical features define the patent's core scope?
The patent's core protection is a combination of formulation and performance limitations rather than a single ingredient.
Oxycodone active ingredient
Claim 1 requires oxycodone or a pharmaceutically acceptable salt. The claim is not limited to a specific oxycodone salt, although commercially relevant products generally use oxycodone hydrochloride.
The "drug prone to abuse" language does not independently expand the claim to all controlled substances. The claim later requires that the drug be oxycodone or an acceptable salt. A formulation based solely on hydrocodone, oxymorphone, morphine, or another opioid would not satisfy this limitation literally.
Fatty-acid concentration
The fatty acids must be present at 42%-69% by weight of each particle. This is one of the most important numerical limitations.
The range is materially narrower than a generic requirement for "a fatty acid." A competing product with 40% fatty acid would fall outside the literal range, subject to possible prosecution-history and doctrine-of-equivalents issues. A formulation at 42% or 69% is within the stated range unless a binding claim-construction ruling changes the treatment of the endpoints.
Claim 4 identifies:
- Linoleic acid
- Octanoic acid
- Capric acid
- Lauric acid
- Myristic acid
- Palmitic acid
- Stearic acid
- Oleic acid
Claim 5 narrows the claim to myristic acid. Myristic acid is commercially significant because claim 8 combines it with oxycodone, beeswax, and carnauba wax.
Wax or wax-like matrix
The particles must include one or more waxes, wax-like substances, or mixtures thereof. Dependent claim 6 identifies beeswax, glycowax, castor wax, carnauba wax, paraffins, microcrystalline wax, and candelilla wax.
Claim 7 narrows this category to beeswax and carnauba wax. Claim 8 combines that wax pair with myristic acid and oxycodone.
The open-ended language permits other excipients, but the formulation must still contain the required wax or wax-like component. A polymer-only matrix with no wax or wax-like material would present a non-infringement position against the literal wax limitation.
Multiparticulate structure and particle size
The claims require a plurality of solid particles. The median particle size, D[0.5], must be about 200-400 microns under claims 1, 9, and 10. Claims 12 and 13 narrow the range to about 250-400 microns.
D[0.5] means that approximately half of the measured particle population is below the stated median and half is above it. Particle-size measurement methodology can become material in an infringement dispute, including sampling, dispersion conditions, agglomeration, sieve analysis, laser diffraction, and treatment of outliers.
The claims do not require all particles to fall within the range. They require the particle population to have the specified median. This creates a potential design-around route through a materially different particle-size distribution, although the word "about" reduces the certainty of a boundary-based design.
Extended-release performance after crushing
The composition must release a therapeutically effective amount over 6-24 hours after administration as directed. It also must maintain slow release when the particles are crushed with a mortar and pestle and swallowed.
This limitation is central to the patent's abuse-deterrence scope. A formulation that has the same ingredients and particle size but releases oxycodone rapidly after crushing could challenge infringement of the performance limitation. Conversely, a product with a similar release profile but a different composition could avoid the composition claims if it does not satisfy the required fatty-acid and wax limitations.
The claim does not require resistance to every abuse route. It specifically recites crushing with a mortar and pestle and swallowing. The patent therefore has a defined mechanical-crushing test profile rather than an unlimited claim to all tamper resistance.
How do the dependent claims narrow the patent?
Claims 2-8 create progressively narrower formulation positions.
Substantially spherical particles
Claim 2 requires substantially spherical particles. This limitation is relevant to manufacturing processes that form droplets or rounded particles, including atomization. Irregular granules may avoid this dependent claim while remaining within claim 1.
Ionic drug-fatty-acid interaction
Claim 3 requires the drug and fatty acid to interact ionically. This is narrower than merely having both components in the same particle. The limitation may require analytical evidence concerning salt formation, ion pairing, or another ionic interaction, depending on claim construction.
Myristic acid, beeswax, and carnauba wax
Claim 8 is the most commercially focused composition claim. It requires:
- Oxycodone;
- Beeswax;
- Carnauba wax; and
- Myristic acid.
The claim remains subject to the particle-size, fatty-acid-percentage, release, and crushing limitations inherited from claim 1.
What manufacturing processes are protected?
Claim 10 protects a method of making the claimed composition by dispersing or dissolving the drug in a wax-containing mixture and forming particles with the specified median size. Because claim 10 depends on claim 1, the resulting composition must also satisfy the claim 1 limitations, including the fatty-acid content and performance requirements.
Claim 11 specifically recites spinning-disc atomization. This process can produce rounded particles by introducing a molten or dissolved formulation onto a rotating disc and converting it into droplets or particles.
The method claims create a separate risk category. A manufacturer could face process-claim exposure even if it disputes a composition claim, particularly where internal manufacturing records, batch specifications, and process parameters establish the use of spinning-disc atomization.
A process that forms particles by spray drying, fluid-bed processing, extrusion, milling, or another technique may avoid claim 11, but it could still infringe claim 10 or the composition claims if the resulting particles meet the required structural and performance limitations.
When does US Patent 9,682,075 expire?
| Event |
Date or status |
| Patent issued |
June 20, 2017 |
| Patent type |
Utility patent |
| Patent term basis |
Twenty years from the applicable earliest nonprovisional or international filing date, subject to adjustment |
| Publicly reported expiration |
March 21, 2032 |
| Current status |
Unexpired based on the reported term |
| Regulatory role |
Listed in the FDA Orange Book for Xtampza ER-related patent protection |
The effective expiration date can be affected by patent-term adjustment, terminal disclaimers, patent-term extension, or other USPTO-specific term calculations. The reported March 21, 2032 date is the principal commercial planning date associated with the patent record and Orange Book materials. [1][2]
The patent is not a biologic patent and does not create a biosimilar pathway. A competitor would ordinarily pursue an ANDA for a generic oxycodone extended-release product, with patent certification under Hatch-Waxman.
What is the Orange Book status of US 9,682,075?
US 9,682,075 is associated with Xtampza ER, an extended-release oxycodone product approved under NDA 208090. FDA approved Xtampza ER in June 2016 as an extended-release oxycodone capsule using abuse-deterrent technology. [3]
The Orange Book is relevant for three reasons:
- It identifies patents submitted by the NDA holder for the listed drug.
- It provides the basis for Paragraph IV certification and potential 30-month stays.
- It identifies any listed method-of-use patents through use codes.
For this patent, the commercial relevance is primarily formulation and product protection. The patent's claims are directed to the physical composition, particle architecture, manufacturing process, and treatment method rather than a broad oxycodone molecule claim.
FDA approval of Xtampza ER does not establish infringement or validity. FDA listing also does not prevent a generic applicant from challenging the patent through an ANDA Paragraph IV certification.
What Paragraph IV challenges and generic-entry risks apply?
A generic applicant seeking approval before patent expiration could certify that US 9,682,075 is invalid, unenforceable, or will not be infringed. A Paragraph IV notice would allow the patent holder to bring an infringement action within 45 days, potentially triggering a 30-month FDA approval stay under 21 U.S.C. § 355(j)(5)(B)(iii).
The principal generic strategies would be:
| Generic strategy |
Potential vulnerability |
| Use a different fatty-acid concentration |
Risk from the "about" range and doctrine of equivalents |
| Replace fatty acids with polymers or other lipids |
May avoid the 42%-69% fatty-acid limitation |
| Use particles outside the 200-400 micron median |
Measurement and "about" language remain relevant |
| Use a non-wax matrix |
Avoids a core composition limitation if no wax-like substance is present |
| Use a different crushing-resistant mechanism |
May avoid the claimed mortar-and-pestle release profile |
| Use a different manufacturing process |
May avoid spinning-disc atomization but not necessarily composition claims |
| Alter the active ingredient or salt |
Oxycodone remains expressly required |
| Challenge the patent's written description or enablement |
Relevant to the broad particle and performance scope |
The most credible design-around path is a formulation that uses a different release-control mechanism and excludes the claimed high fatty-acid content. A product that merely changes the wax blend or shifts particle size modestly would face a higher risk because the patent contains broad independent claims and narrower fallback claims.
How strong is the patent estate for Xtampza ER?
US 9,682,075 is commercially important because it covers the product's underlying abuse-deterrent multiparticulate architecture. Its strength is greater when the marketed product's specifications align closely with the claimed combination of oxycodone, fatty acid, wax matrix, particle size, and crushing performance.
Its principal limitations are:
- The claims are formulation-specific.
- The fatty-acid range is numerically defined.
- The particle-size range can be tested and targeted by a generic manufacturer.
- The crushing limitation may require detailed comparative dissolution evidence.
- The patent does not cover every extended-release oxycodone formulation.
- Validity may be challenged using prior art involving wax matrices, fatty-acid excipients, multiparticulates, and abuse-deterrent opioid formulations.
The dependent claims provide useful fallback positions. Claim 8 is narrower but may closely track the commercial formulation. Claim 11 protects a particular manufacturing route. Claims 12 and 13 provide an alternative particle-size limitation but also narrow the available scope.
What patents protect competing abuse-deterrent oxycodone products?
Xtampza ER competes with other extended-release oxycodone products that use different abuse-deterrent technologies.
| Product |
Sponsor or manufacturer |
Abuse-deterrent approach |
Patent risk profile |
| Xtampza ER |
Collegium Pharmaceutical |
Oxycodone in wax-fatty-acid multiparticulates |
Directly relevant to US 9,682,075 |
| OxyContin OP |
Purdue Pharma |
Physically and chemically resistant tablet technology |
Separate tablet, polymer, and formulation patent estate |
| Hysingla ER |
Purdue Pharma |
Hard, abuse-deterrent hydrocodone tablet |
Hydrocodone product, not a direct oxycodone claim overlap |
| Arymo ER |
Egalet |
Polymer-based, abuse-deterrent morphine formulation |
Different opioid and dosage-form technology |
| Generic oxycodone ER |
Potential ANDA applicants |
May use alternative matrix or multiparticulate systems |
Paragraph IV and formulation-design risk |
OxyContin OP uses a tablet-based technology and is not a direct structural match to the wax-fatty-acid particles claimed in US 9,682,075. Hysingla ER and Arymo ER use different active ingredients, which generally removes them from the literal scope of the oxycodone limitation. [4][5]
What litigation and settlement issues affect the patent?
The relevant dispute pattern is an ANDA-based patent challenge involving a generic oxycodone extended-release product. The central litigation questions would include:
- Whether the proposed generic contains 42%-69% fatty acids by particle weight;
- Whether its median particle size falls within approximately 200-400 microns;
- Whether its particles contain a wax or wax-like substance;
- Whether crushed particles retain extended release;
- Whether the proposed manufacturing process uses spinning-disc atomization;
- Whether the claims are invalid over prior art;
- Whether the patent's functional limitations are definite and enabled.
A settlement could permit a generic launch before March 2032 through a licensed entry date, an authorized generic arrangement, or a negotiated launch tied to litigation outcomes. A settlement does not change the patent's expiration date or automatically eliminate Orange Book protection.
The commercial impact of any settlement depends on whether the generic can launch before patent expiry and whether the agreement restricts an authorized generic, distribution channels, dosage strengths, or product substitution. Public litigation and FDA records should be reviewed for the operative complaint, ANDA number, asserted claims, and settlement terms. [1][2][6]
What manufacturing and intellectual-property barriers remain after patent expiry?
Patent expiry would remove the principal enforceable rights under US 9,682,075, but commercial entry would still require:
- FDA ANDA approval;
- Bioequivalence to Xtampza ER;
- Demonstration of comparable extended-release performance;
- Compliance with opioid labeling and controlled-substance requirements;
- Manufacturing controls for particle-size distribution;
- Process validation for wax and fatty-acid content;
- Abuse-deterrent labeling support where applicable;
- Freedom-to-operate review of later-issued formulation, process, and capsule patents.
A generic may also face separate patents covering dosage strengths, capsule components, dissolution specifications, manufacturing equipment, or later improvements. Expiration of US 9,682,075 therefore removes one major barrier but does not necessarily establish complete freedom to launch.
What is the geographic coverage of US 9,682,075?
US 9,682,075 is enforceable only in the United States. It does not directly control sales, manufacture, importation, or use in Canada, Europe, Japan, or other jurisdictions.
Related national patents or applications may exist in jurisdictions claiming priority to the same international filing. Each jurisdiction requires separate analysis of:
- Patent grant status;
- Claim scope;
- Local patent-term rules;
- Patent-term adjustments or supplementary protection;
- Orange Book or equivalent regulatory listings;
- Local generic or hybrid application procedures;
- Litigation and settlement history.
A US design-around does not establish freedom to operate in foreign markets, and a foreign patent's expiration date may differ from the US date.
Key Takeaways
- US 9,682,075 covers an abuse-deterrent oxycodone multiparticulate composition, not all extended-release oxycodone products.
- The principal limitations are wax or wax-like material, 42%-69% fatty acids, 200-400 micron median particle size, 6-24-hour release, and sustained release after crushing.
- Claim 8 narrowly targets oxycodone with beeswax, carnauba wax, and myristic acid.
- Claims 9-11 add treatment and manufacturing protection, including spinning-disc atomization.
- The patent is associated with Xtampza ER and is publicly reported to expire on March 21, 2032.
- A generic applicant's strongest design-around strategy is likely a different matrix technology combined with a materially different fatty-acid composition and particle-size distribution.
- Generic entry before expiry would normally require a Paragraph IV challenge, a litigation resolution, or a licensed settlement.
- The patent is a small-molecule formulation patent. Biosimilar risk is not applicable.
- Patent expiry alone does not eliminate later-issued formulation, process, capsule, or regulatory barriers.
FAQs
Can a generic oxycodone product avoid US 9,682,075 by using a tablet instead of particles?
Potentially. The claims require a plurality of solid particles with a defined median particle size. A conventional monolithic tablet would not literally satisfy that particle limitation, although separate patents and infringement theories would require review.
Does using a different oxycodone salt avoid the patent?
Not necessarily. Claim 1 covers oxycodone and pharmaceutically acceptable salts. Changing from oxycodone hydrochloride to another acceptable salt may remain within the claim.
Does the patent cover nasal or injectable abuse-deterrent oxycodone products?
The claims recite oral administration and swallowing of crushed particles. A nonoral product would generally present a weaker literal infringement case, but the full product and method claims must be analyzed.
Is claim 8 limited to a specific ratio of beeswax, carnauba wax, and myristic acid?
The supplied claim text does not impose separate ratios for those three ingredients. It remains subject to the inherited 42%-69% fatty-acid range and the other limitations of claim 1.
Can a generic use spinning-disc atomization after US 9,682,075 expires?
After expiration, claim 11 would no longer block the process. Before expiration, use of spinning-disc atomization could create direct process-claim risk if the resulting product and inherited claim 1 limitations are satisfied.
References
- United States Patent and Trademark Office. (2017). U.S. Patent No. 9,682,075, Tamper resistant pharmaceutical compositions. https://patents.google.com/patent/US9682075B2/en
- U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
- U.S. Food and Drug Administration. (2016). FDA approves abuse-deterrent labeling for Xtampza ER. https://www.fda.gov/
- U.S. Food and Drug Administration. (2015). FDA approves Hysingla ER with abuse-deterrent properties. https://www.fda.gov/
- U.S. Food and Drug Administration. (2017). FDA approves Arymo ER with abuse-deterrent properties. https://www.fda.gov/
- U.S. Code, 21 U.S.C. § 355(j). (2024). Abbreviated applications for new drugs. https://uscode.house.gov/
