United States Drug Patent 7,674,799: Claim Scope, Expiration, Orange Book Status, and Oxycodone Patent Landscape

US Patent 7,674,799 covers oral oxycodone hydrochloride dosage forms containing less than 25 parts per million of 14-hydroxycodeinone, where at least some of the impurity originates from 8α,14-dihydroxy-7,8-dihydrocodeinone formed during conversion of oxycodone free base to oxycodone hydrochloride. The patent also requires, in certain claims, sustained-release particles, film coating, a sustained-release carrier, or specified dosage strengths.

The patent is narrower than a general patent on oxycodone or extended-release oxycodone. Its central limitation is the combination of a low impurity specification with an origin-of-impurity limitation. Based on the patent’s earliest priority date, the ordinary 20-year patent term reached its end in late 2023, subject to any patent-term adjustment, terminal disclaimer, or other recorded term modification.[1][2]

What does US Patent 7,674,799 protect?

US 7,674,799 protects oral dosage forms that combine oxycodone hydrochloride with a defined impurity profile and, for some claims, a controlled-release architecture.

The patent’s principal technical elements are:

Element	Scope
Active ingredient	Oxycodone hydrochloride
Oxycodone amount	About 5 mg to about 320 mg in the independent claims
Impurity limit	Less than 25 ppm 14-hydroxycodeinone
Required impurity origin	At least part of the 14-hydroxycodeinone must derive from 8α,14-dihydroxy-7,8-dihydrocodeinone during conversion of oxycodone free base to oxycodone hydrochloride
Dosage form	Oral dosage form
Release design in claim 1	Particles coated with hydrophobic material effective to provide sustained release
Release design in claim 2	Sustained-release material film coated onto oxycodone hydrochloride
Claim 3 formulation requirement	Pharmaceutically acceptable excipient
Narrower dosage forms	Tablets or capsules
Listed strengths	5, 10, 15, 20, 30, 40, 50, 60, 80, 100, 160, and 320 mg, with narrower claims listing selected strengths

The patent is therefore directed to a quality-controlled oxycodone hydrochloride product, not merely to a release profile.

How do the independent claims differ?

Claim 1: sustained-release coated particles

Claim 1 requires:

Oxycodone hydrochloride containing less than 25 ppm 14-hydroxycodeinone.
At least some of that impurity being derived from the specified dihydrocodeinone intermediate.
Particles containing the oxycodone hydrochloride.
A hydrophobic coating that produces sustained release in aqueous solution.
Approximately 5 mg to approximately 320 mg of oxycodone hydrochloride.

This is the most technically specific independent claim. A competing product would need to avoid at least one of the following limitations to avoid literal infringement: the impurity threshold, the specified origin of the impurity, the particle structure, the hydrophobic coating, the sustained-release function, or the stated dose range.

Claim 2: film-coated active pharmaceutical ingredient

Claim 2 requires the same low-impurity oxycodone hydrochloride and impurity-origin limitations, but specifies that the sustained-release material is film coated onto the active pharmaceutical ingredient.

The distinction from claim 1 is structural. Claim 1 focuses on coated particles. Claim 2 focuses on film coating the oxycodone hydrochloride active pharmaceutical ingredient. Depending on the manufacturing process and formulation architecture, a dosage form could fall within one claim and not the other.

Claim 3: broad dosage-form claim

Claim 3 requires:

An oral dosage form;
5 mg to 320 mg of the specified oxycodone hydrochloride; and
A pharmaceutically acceptable excipient.

It does not expressly require sustained release. Claim 3 is consequently the broadest independent claim in formulation terms. Its breadth is constrained by the low 14-hydroxycodeinone concentration and the required source of at least part of the impurity.

A product containing oxycodone hydrochloride below the 25 ppm threshold could still avoid claim 3 if the accused oxycodone hydrochloride does not contain 14-hydroxycodeinone derived from 8α,14-dihydroxy-7,8-dihydrocodeinone, although proving that distinction would require appropriate process and analytical evidence.

What are the key limitations in the 7,674,799 patent claims?

The less-than-25-ppm impurity limitation

The phrase “less than 25 ppm” creates an upper-bound requirement. A batch at 25 ppm or higher would not satisfy that limitation literally. The claims also identify lower limits of 0.25, 0.5, 1, 2, or 5 ppm in dependent claims.

These lower limits should not be read as requiring a minimum impurity level in every embodiment unless the applicable claim expressly incorporates that limitation. The dependent claims narrow the permissible concentration range by selecting a lower endpoint while retaining the less-than-25-ppm ceiling.

The impurity-source limitation

The claims do not merely require the presence of 14-hydroxycodeinone. They require that at least some of it be derived from 8α,14-dihydroxy-7,8-dihydrocodeinone during conversion of oxycodone free base to oxycodone hydrochloride.

This limitation creates a product-and-process evidentiary issue. A patent owner would likely need to establish:

The amount of 14-hydroxycodeinone in the oxycodone hydrochloride;
The analytical method used to quantify it;
The presence or formation pathway of 8α,14-dihydroxy-7,8-dihydrocodeinone;
The relationship between the conversion step and the impurity; and
Whether the accused product’s impurity is attributable to that pathway.

Claims 4, 5, and 7 state that the impurity is derived solely from the specified intermediate. “Solely” imposes a materially narrower source limitation than “at least a portion.”

The sustained-release limitation

Claims 1 and 2 require sustained release. The specification likely supports multiple controlled-release materials and coating approaches, but an accused product must still satisfy the claim language as construed.

A hydrophobic coating alone is not necessarily enough for claim 1. The coating must be present in an amount effective to provide sustained release when exposed to an aqueous solution. Claim 2 requires the sustained-release material to be film coated onto the oxycodone hydrochloride active pharmaceutical ingredient.

The dosage-form and dose limitations

The independent claims use “oral dosage form.” Dependent claims narrow the form to tablets or capsules and identify specific oxycodone hydrochloride amounts.

The dose limitations are relevant to product-by-product analysis. A dosage form outside the claimed approximate range could avoid the literal dose limitation, although the treatment of “about” would depend on claim construction and the evidence concerning ordinary pharmaceutical manufacturing tolerances.

How strong is the patent estate for US 7,674,799?

The patent’s strongest commercial position was its ability to cover a low-impurity oxycodone hydrochloride formulation irrespective of whether the product used a particular branded release technology, provided that the product met the impurity-source limitation.

Its principal strengths were:

The impurity limit was expressed as a measurable product attribute.
Claim 3 did not require sustained release.
The claims covered multiple doses and oral dosage forms.
The claims linked the impurity to a defined manufacturing conversion step.
Dependent claims supplied narrower fallback positions based on impurity concentration, tablet or capsule form, and dosage strength.

Its principal vulnerabilities were:

The impurity-source limitation may be difficult to prove from finished-product testing alone.
The claim language may invite written-description, enablement, indefiniteness, anticipation, or obviousness challenges depending on the prior art and prosecution history.
A generic manufacturer could potentially design around the claim by using oxycodone hydrochloride made through a process that does not produce the specified impurity or by controlling the impurity below the claimed range.
The product claims do not cover every oxycodone dosage form, every oxycodone salt, or every extended-release technology.
The patent term has ended under the ordinary term calculation based on the earliest priority date.[1][2]

When did US Patent 7,674,799 expire?

The patent’s earliest priority date is reported as November 14, 2003. The ordinary patent term for a utility patent is 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment and other statutory modifications.[1]

Event	Date or status
Earliest priority date	November 14, 2003
Patent issued	March 9, 2010
Ordinary 20-year term endpoint	November 14, 2023
Practical assessment	Ordinary term has ended, subject to any recorded adjustment or disclaimer
Current business implication	The patent should not ordinarily block a new generic launch solely because of its unexpired term

Patent expiration should be confirmed against the USPTO Patent Center record and the current FDA Orange Book patent listing before a litigation or launch decision. The issuance date does not control the ordinary term for a post-1995 US utility patent.[1][2]

What is the Orange Book status of US 7,674,799?

The FDA Orange Book identifies patents submitted by NDA holders for approved drug products, including patents covering drug substances, formulations, methods of use, and related characteristics.[3]

US 7,674,799 has been associated with the oxycodone extended-release patent landscape, including OxyContin-related patent activity. Its commercial relevance was greatest when the patent was listed against an approved oxycodone extended-release product and remained unexpired.

An Orange Book listing does not itself establish that every claim is valid, enforceable, or infringed. It can, however, affect an ANDA applicant’s regulatory strategy. A listed patent can trigger a Paragraph IV certification, notice obligations, and potential Hatch-Waxman litigation.[4]

Because Orange Book records can change through patent expiration, delisting, product changes, and FDA administrative updates, the current listing should be read together with the patent’s USPTO status and the applicable NDA record.

What Paragraph IV challenges and litigation affect this patent?

A Paragraph IV certification asserts that a listed patent is invalid, unenforceable, or will not be infringed by the proposed generic product.[4] For US 7,674,799, the most likely technical theories would have centered on the following issues:

Issue	Potential generic position
Impurity concentration	The product contains 25 ppm or more, or otherwise does not meet the claimed concentration range
Impurity origin	The 14-hydroxycodeinone was not derived from the specified intermediate during salt formation
Analytical proof	The patent owner cannot reliably establish the claimed impurity level or origin
Release architecture	The formulation lacks hydrophobic coated particles or the claimed film coating
Oral dosage form	The proposed product does not satisfy the claimed form or dose limitation
Validity	Prior art allegedly discloses or renders obvious the claimed low-impurity formulation
Enablement	The claims may cover products not enabled across their full breadth
Enforceability	Prosecution conduct or disclosure issues could be raised if supported by the record

The patent’s expiration materially changes the litigation analysis. A post-expiration ANDA launch generally does not create the same forward-looking injunction risk as a launch before the patent term ends. Historical Paragraph IV litigation, settlement terms, damages exposure, and launch dates remain relevant for past conduct and for understanding the competitive landscape.

No public license or settlement term should be attributed specifically to US 7,674,799 without a document identifying that patent by number. OxyContin-related settlements and licensing arrangements may involve other Purdue patents, abuse-deterrent technology, or separate formulation rights.

What formulations are protected by the patent?

The claims reach several formulation categories:

Sustained-release multiparticulates

Claim 1 covers particles containing low-impurity oxycodone hydrochloride that are coated with hydrophobic material. This structure is relevant to multiparticulate capsules, coated pellets, beads, or other particle-based oral systems.

Film-coated oxycodone hydrochloride

Claim 2 covers an active pharmaceutical ingredient with sustained-release material film coated onto it. The claim may be relevant to coated granules, coated crystals, or other active-containing particles, depending on the construction of “film coated onto.”

Tablets and capsules

Claims 10, 13, and 16 narrow the relevant dosage forms to tablets or capsules. The patent does not, based on the supplied claims, expressly require a specific tablet compression technology, capsule shell, excipient system, or dissolution profile beyond the sustained-release requirements in claims 1 and 2.

Immediate-release dosage forms

Claim 3 is broad enough, on its face, to reach an oral dosage form without an express sustained-release limitation. The claim still requires the low-impurity oxycodone hydrochloride, the specified impurity origin, the dose range, and a pharmaceutically acceptable excipient.

How does 7,674,799 compare with other oxycodone patents?

US 7,674,799 should be separated from three other patent groups:

Patent group	Primary subject	Relationship to 7,674,799
Original controlled-release oxycodone patents	Controlled-release oxycodone formulations and dosage forms	Often focus on release technology rather than impurity origin
Abuse-deterrent OxyContin patents	Physical and chemical resistance to crushing, dissolving, or extraction	May protect a different product layer and may have later expiration dates
Manufacturing and impurity patents	Purification, salt formation, process control, and impurity reduction	More directly related to the technical core of 7,674,799

A generic product can face layered patent risk even if 7,674,799 has expired. The remaining risks may arise from later patents covering abuse-deterrent matrices, tamper-resistant tablets, manufacturing processes, methods of use, or specific dissolution profiles.

What generic entry risks exist after patent expiration?

After expiration, the principal risks shift from 7,674,799 itself to other rights and regulatory requirements.

Product-development risks

A generic manufacturer must establish that its oxycodone hydrochloride meets applicable impurity specifications and that its process is reproducible. The expired patent may still disclose process controls that influence development, but it ordinarily no longer creates a future injunction barrier.

Orange Book and ANDA risks

The applicant must certify to listed patents associated with the reference listed drug. Paragraph III certifications can defer approval until patent expiration. Paragraph IV certifications can accelerate approval but may trigger litigation under the Hatch-Waxman framework.[4]

Remaining formulation patents

Later OxyContin or oxycodone extended-release patents may cover abuse-deterrent features or particular compositions. These patents can be more commercially significant than 7,674,799 for a current generic entrant if they remain unexpired and are listed against the reference product.[3]

Manufacturing and supply-chain risks

The 7,674,799 claims link the impurity to conversion of oxycodone free base into oxycodone hydrochloride. Even after expiration, manufacturers need validated controls for 14-hydroxycodeinone and related impurities. The relevant barriers are likely to be regulatory quality requirements, analytical validation, API sourcing, and process reproducibility rather than exclusive rights under this patent.

What is the competitive landscape for oxycodone extended-release products?

The competitive field includes:

Purdue’s OxyContin extended-release oxycodone product;
Authorized or branded-generic versions;
FDA-approved generic oxycodone hydrochloride extended-release tablets;
Suppliers of oxycodone hydrochloride active pharmaceutical ingredient;
Manufacturers of abuse-deterrent opioid formulations; and
Developers of alternative extended-release opioid products.

The commercial value of US 7,674,799 was tied to the oxycodone extended-release market and the ability to control a quality attribute shared by multiple dosage strengths. Its value is now primarily historical, evidentiary, and relevant to freedom-to-operate reviews covering past sales or legacy products.

Revenue exposure cannot be assigned reliably to this patent alone because the same product can be protected by several patents and regulatory exclusivities. Product-level sales should be allocated across the broader OxyContin patent estate rather than attributed exclusively to US 7,674,799.

Key Takeaways

US 7,674,799 claims oral oxycodone hydrochloride dosage forms with less than 25 ppm 14-hydroxycodeinone.
The critical claim limitation is that at least part of the impurity must derive from 8α,14-dihydroxy-7,8-dihydrocodeinone during conversion of oxycodone free base to oxycodone hydrochloride.
Claim 3 is the broadest independent claim because it does not expressly require sustained release.
Claims 1 and 2 add particle-coating and film-coating limitations tied to sustained release.
Dependent claims narrow the claims by impurity floor, dosage form, and oxycodone strength.
The ordinary 20-year term reached November 14, 2023, based on the reported earliest priority date.
Paragraph IV risk historically would have focused on impurity measurement, impurity origin, formulation structure, and patent validity.
Current generic-launch risk is more likely to arise from later oxycodone formulation or abuse-deterrent patents than from US 7,674,799 itself.
The patent does not broadly cover all oxycodone products, all oxycodone salts, or every extended-release formulation.
A current freedom-to-operate analysis must review the complete Orange Book and USPTO family records, not this patent in isolation.

FAQs

Does US 7,674,799 cover immediate-release oxycodone?

Claim 3 does not expressly require sustained release, but it still requires the specified low-impurity oxycodone hydrochloride, impurity origin, oral dosage form, dose range, and excipient.

Is less than 25 ppm 14-hydroxycodeinone enough to infringe?

No. The claims also require oxycodone hydrochloride and the specified origin of at least part of the impurity. Claims 1 and 2 add release and coating limitations.

Does the patent cover oxycodone base?

No. The supplied claims are directed to oxycodone hydrochloride in an oral dosage form. Oxycodone free base appears in the claimed impurity-generation pathway, not as the claimed active ingredient.

Can a generic avoid the patent by using a different oxycodone hydrochloride manufacturing process?

Potentially. A process that does not produce 14-hydroxycodeinone from the specified intermediate could avoid a key claim limitation, but the conclusion would depend on analytical, process, and claim-construction evidence.

Does patent expiration eliminate FDA exclusivity?

No. Patent expiration and FDA regulatory exclusivity are separate. FDA exclusivity may arise from the NDA, clinical investigations, orphan-drug status, or other statutory provisions, while patent rights arise under Title 35.[1][3]

References

United States Patent and Trademark Office. (n.d.). Patent term adjustment and patent term provisions. https://www.uspto.gov/patents/laws/patent-term-adjustment
United States Patent and Trademark Office. (2010). US Patent No. 7,674,799, oxycodone hydrochloride compositions and methods of making same.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugsatfda
U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application submissions and patent certifications under the Hatch-Waxman Act. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/abbreviated-new-drug-application-anda-submissions

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	2232	⤷ Start Trial
Argentina	049012	⤷ Start Trial
Argentina	118531	⤷ Start Trial
Argentina	124161	⤷ Start Trial
Austria	9952	⤷ Start Trial
Austria	E501150	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,674,799

Summary for Patent: 7,674,799