Details for Patent: 9,763,933

Which drugs does patent 9,763,933 protect, and when does it expire?

Patent 9,763,933 protects HYSINGLA ER and OXYCONTIN and is included in two NDAs.

This patent has two hundred and twenty-one patent family members in forty countries.

Summary for Patent: 9,763,933

Title:	Tamper resistant dosage forms
Abstract:	The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):	William H. McKenna, Richard O. Mannion, Edward P. O'Donnell, Haiyong H. Huang
Assignee:	Purdue Pharma LP , Purdue Pharmaceuticals LP
Application Number:	US15/413,614
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,763,933
Patent Claim Types: see list of patent claims	Composition; Compound; Device; Dosage form;

United States Patent 9,763,933: Claim Scope, PEO Extended-Release Tablets, and Patent Landscape

United States Patent No. 9,763,933 covers solid oral extended-release tablets made with at least 30% high-molecular-weight polyethylene oxide, or PEO, followed by heated-air curing without compression. The strongest claims target opioid tablets containing at least 1.3% active agent, at least 60°C curing, tablet expansion, high tablet hardness, and convection curing in a coating pan or comparable device.

The patent is directed principally to formulation and manufacturing architecture rather than to a particular opioid molecule. A competing product can face infringement risk even if it uses a different opioid, additive package, film coating, tablet shape, or commercial strength, provided it satisfies the claimed PEO concentration, molecular-weight, curing, and dosage-form limitations.

What does United States Patent 9,763,933 protect?

The patent protects a combination of composition and process limitations. The core claim requires all of the following:

Limitation	Core requirement
Dosage form	Solid oral extended-release dosage form
Active agent	At least one active pharmaceutical agent
Polymer	High-molecular-weight PEO with approximate molecular weight of 1 million to 15 million
Polymer concentration	At least about 30% by weight of the dosage form
Shaping	Compression-shaped dosage form
Thermal treatment	Heated-air curing without compression
Curing time	At least about 5 minutes in claim 1; at least 10 minutes in the opioid claim
Curing temperature	Above the softening temperature in claim 1; at least about 60°C in claim 11
Post-curing steps	Cooling and hardening
Molecular-weight measurement	Rheological measurement
Weight calculation	Film-coating weight excluded from dosage-form weight

The claims do not require a named commercial product, a specific opioid, a particular release profile, or a particular PEO supplier. The patent therefore has broad platform characteristics within the defined manufacturing window.

How do independent claims 1 and 11 differ?

Claim 1 is the broader composition claim. Claim 11 is narrower but commercially more relevant because it expressly covers opioid formulations.

Feature	Claim 1	Claim 11
Active agent	Any active agent	Opioid or pharmaceutically acceptable salt
High-molecular-weight PEO	1 million to 15 million	1 million to 8 million
Minimum active-agent loading	Not specified	At least about 1.3%
Additive	Optional	At least one specified additive category
Curing	At least 5 minutes above softening temperature	At least 10 minutes at at least 60°C
Formulation type	Extended-release oral dosage form	Extended-release opioid dosage form
Commercial relevance	Platform scope	Direct opioid-tablet scope

Claim 11 is likely to be the principal claim for an opioid product using the claimed manufacturing process. Claims 12 through 30 add process controls and formulation restrictions that may make infringement easier to establish where manufacturing records are available.

What formulation characteristics are protected?

High-molecular-weight PEO

The claims require high-molecular-weight PEO in a range of approximately 1 million to 15 million, measured by rheological methods. Claim 11 narrows the range to approximately 1 million to 8 million.

The rheological-measurement limitation matters. A supplier’s nominal grade designation, viscosity label, or gel-permeation-chromatography result may not independently establish the molecular weight required by the claims. A technical infringement analysis would need to determine whether the accused PEO satisfies the claim under the specified rheological methodology.

PEO concentration

The minimum high-molecular-weight PEO concentration is approximately 30% by weight. Dependent claims add higher total PEO thresholds:

Claim	Total high- plus low-molecular-weight PEO
16	At least about 65%
17	At least about 80%
20	At least about 50%
26	At least about 65%
27	At least about 90%
29	At least about 50%

These limitations create a broad claim ladder. A product may avoid a dependent claim by using less than the specified total PEO percentage while remaining exposed under claim 11 if it contains at least 30% high-molecular-weight PEO.

Low-molecular-weight PEO

Claims 8, 18, and 28 specify low-molecular-weight PEO of approximately 100,000 to 900,000. The low-molecular-weight PEO is optional. Its absence does not avoid the independent claims.

Active-agent loading

Claim 11 requires the active agent to comprise at least approximately 1.3% of the dosage form. Claim 14 narrows the active-agent list to buprenorphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, morphine, or their pharmaceutically acceptable salts and requires at least approximately 2.4% by weight of each tablet.

The claim language is not limited to oxycodone. A qualifying extended-release tablet containing another listed opioid may fall within claim 14 if the remaining limitations are met.

What manufacturing process is protected?

The patent’s process limitations are central to its scope.

Compression followed by heated-air curing

The claimed sequence is:

1. Compress and shape the formulation.
2. Cure the tablets with heated air without compression.
3. Cool the tablets.
4. Harden the tablets.

The process is different from a formulation that is thermally treated before compression or from a tablet cured under pressure. The “without compression” limitation may provide a non-infringement position for products subjected to hot compaction, roller compaction, or another pressure-assisted post-shaping process.

Curing temperature and duration

The claims establish overlapping temperature and time ranges:

Claim	Temperature	Time
1	Above softening temperature	At least about 5 minutes
3	About 70°C to 85°C	About 10 minutes to 10 hours
4	At least about 60°C	At least about 10 minutes
5	At least about 60°C and not above about 90°C	At least 10 minutes and not above 24 hours
6	Same general range	Not above about 10 hours
11	At least about 60°C	At least about 10 minutes
12	About 60°C to 90°C	About 10 minutes to 10 hours
15	About 70°C to 85°C	Not separately narrowed

A process operating at 70°C to 85°C for 10 minutes to 10 hours is particularly exposed because it sits inside several dependent claims.

Coating-pan curing

Claim 22 specifies a coating pan. Claims 23 and 24 add a plateau-like temperature profile and cooling at approximately 30°C to 34°C.

The coating-pan limitations are significant for process discovery. Relevant evidence can include:

• Inlet-air and exhaust-air records.
• Batch manufacturing records.
• Coating-pan temperature profiles.
• Tablet-bed temperature data.
• Cooling-air records.
• Cure duration.
• Post-cure tablet density and hardness.
• Batch formulas and component percentages.

The claims define curing and cooling temperature as either inlet-air or exhaust-air temperature. That language can create a factual dispute where the manufacturing process records report only one temperature measurement.

What opioid products are most exposed?

Claim 14 specifically names seven opioid actives.

Opioid	Claim 14 coverage
Buprenorphine	Expressly listed
Oxycodone	Expressly listed
Oxymorphone	Expressly listed
Hydrocodone	Expressly listed
Hydromorphone	Expressly listed
Morphine	Expressly listed
Pharmaceutically acceptable salts	Included

A listed opioid alone does not establish infringement. The product must also meet the PEO, loading, tablet, curing, additive, and process limitations incorporated from claim 12.

For oxycodone products, the patent is most relevant to extended-release tablets using a high-PEO matrix and thermal post-curing. For buprenorphine and other opioids, the claim language creates potential coverage even where the patent was commercially associated with a different product.

How strong is the patent estate?

The patent’s strongest characteristics are its manufacturing specificity and claim layering.

Strengths

• It combines formulation and process limitations.
• It covers a broad class of active agents in claim 1.
• It separately targets opioid formulations in claim 11.
• It includes dependent claims directed to commercially realistic curing conditions.
• It covers high PEO concentrations used in robust hydrophilic matrices.
• It includes process claims tied to coating-pan operation.
• It defines measurable physical outcomes, including density reduction and tablet hardness.
• It excludes film-coating weight from the dosage-form calculation, limiting an easy design-around based on coating mass.

Vulnerabilities

• The claims require proof of specific PEO molecular-weight measurements.
• The “approximate” molecular-weight language can create construction and testing disputes.
• The “without compression” limitation may narrow process infringement.
• The claims require detailed manufacturing facts that may not appear in public product labeling.
• Density reduction and hardness limitations in claims 9, 13, and 25 may require batch testing.
• A product using a different polymer, a lower PEO concentration, or a different curing sequence may avoid literal infringement.

The strongest enforcement position would likely arise where a competitor’s formulation and manufacturing process closely replicate the claimed high-PEO, post-compression, heated-air-curing approach.

What additives and coatings are protected?

Claims 10, 11, 12, and 19 address additives. The specified additive categories include:

• Anti-tacking agents.
• Antioxidants.
• Immediate-release components.
• Retardants.

Claim 19 lists specific examples, including:

• Butylated hydroxytoluene.
• Magnesium stearate.
• Talc.
• Silica and fumed silica.
• Colloidal silicon dioxide.
• Calcium stearate.
• Carnauba wax.
• Stearic acid.
• Stearyl alcohol.
• Mineral oil.
• Paraffin.
• Microcrystalline cellulose.
• Glycerin.
• Propylene glycol.
• Polyethylene glycol.
• Lactose.
• Povidone.
• Triacetin.
• Hydroxypropyl cellulose.
• Hydroxypropyl methylcellulose.
• Copolymers comprising methyl methacrylate.

The film coating is optional. Where present, its weight is excluded from the dosage-form weight calculation. A thick coating therefore cannot reduce the calculated percentage of PEO or active ingredient for purposes of the claims.

What tablet properties are protected?

Several dependent claims require expansion after curing, measured as a density decrease:

Claims	Minimum density decrease
9, 13	At least about 1%
25	At least about 2%

Claim 9 also requires hardness of at least about 439 N. The patent therefore links manufacturing conditions to measurable physical properties.

These limitations may be useful in an enforcement case because they can be tested on retained samples or reconstructed through controlled laboratory experiments. They also provide potential invalidity or non-infringement issues if the claimed thresholds are not reproducible across batches.

What is the likely Orange Book relevance?

The patent’s Orange Book relevance depends on whether it is listed for a specific approved drug application and whether the patent claims an approved formulation, method of use, or drug substance. The claim text is directed to pharmaceutical compositions and manufacturing characteristics. It does not, on its face, recite a particular approved indication.

Under FDA listing rules, a patent generally must claim the approved drug, a formulation or composition of the approved drug, or an approved method of use to qualify for listing in the Orange Book (FDA, 2024a). A formulation patent directed to an opioid extended-release tablet may be listed if it claims the approved product’s composition. A manufacturing-only claim may face a more limited listing basis.

The Orange Book should be checked for:

• Patent number 9,763,933.
• Any related continuation or divisional patents.
• Listed expiration date.
• Approved drug application number.
• Patent-use code.
• Delisting history.
• Whether the patent is listed against a specific oxycodone or opioid product.

The patent number alone does not establish current Orange Book listing status.

When does United States Patent 9,763,933 lose exclusivity?

The patent’s enforceable expiration date must be taken from the USPTO patent record, including any patent-term adjustment, patent-term extension, terminal disclaimer, or post-grant legal event. A filing date or issue date is not sufficient to calculate the operative expiration date.

For commercial planning, the relevant timeline is:

Event	Business significance
Patent grant	Creates enforceable issued claims
Patent-term adjustment	May extend the nominal term
Terminal disclaimer	May align expiration with a related patent
Patent-term extension	May extend regulatory exclusivity for qualifying delay
Maintenance-fee events	Can affect enforceability
Reexamination or post-grant proceedings	Can modify or cancel claims
Court judgment	Can affect enforceability against a particular party

Patent expiration does not eliminate separate regulatory exclusivity, other listed patents, pediatric exclusivity, or orphan-drug exclusivity. Conversely, FDA approval does not remove an unexpired formulation or manufacturing patent.

What Paragraph IV challenges and generic-entry risks exist?

A generic applicant could challenge the patent through a Paragraph IV certification if the patent is listed for the reference-listed drug. The likely theories would fall into four groups:

Non-infringement

A proposed product could argue that it:

• Uses less than 30% high-molecular-weight PEO.
• Uses a polymer outside the claimed molecular-weight range.
• Uses a non-PEO release polymer.
• Does not undergo heated-air curing after compression.
• Is cured below the claimed temperature.
• Is cured for less than the claimed duration.
• Is not expanded or does not reach the claimed hardness.
• Uses an active-agent concentration below the claim threshold.

Invalidity

Potential invalidity theories would focus on:

• Anticipation by prior high-PEO extended-release tablets.
• Obviousness based on known PEO matrices and thermal curing.
• Indefiniteness of “approximate” molecular weight.
• Enablement across the broad active-agent and PEO ranges.
• Written-description support for the full combination of process and composition limitations.

Claim construction

Disputes may involve:

• The meaning of “high molecular weight.”
• The required rheological measurement method.
• Whether “air cured” requires a particular equipment configuration.
• Whether “without compression” excludes incidental tablet-bed pressure.
• How density is calculated.
• How film coating is excluded from total dosage-form weight.
• Whether “at least about” permits measurement variation.

Formulation redesign

A generic manufacturer can reduce risk by changing the polymer system, reducing PEO loading, using a different thermal process, or avoiding the specified coating-pan conditions. A redesign must be evaluated against every independent and dependent claim, including possible equivalents theories.

Which companies are challenging the patent?

The supplied claim text does not identify any Paragraph IV filer, district-court defendant, settlement party, or licensee. No company-specific challenge, litigation result, or settlement term can be attributed to Patent 9,763,933 solely from the claims.

A complete litigation review would require the USPTO Patent Center record, FDA Orange Book entries, ANDA litigation notices, PACER dockets, and relevant district-court opinions. The patent claims alone do not establish whether a Paragraph IV challenge has been filed or whether the patent is currently asserted.

What licensing and commercial barriers does the patent create?

The patent may create a licensing barrier for manufacturers seeking to use:

• High-PEO matrix technology.
• Post-compression heated-air curing.
• Coating-pan curing of opioid tablets.
• High polymer-load formulations with tablet expansion.
• Robust extended-release tablets using listed opioids.

A license assessment should distinguish between composition rights and process rights. A company may avoid a composition claim but still practice a claimed curing process. Conversely, it may use a similar manufacturing process with a formulation outside the claimed PEO or opioid limitations.

The principal manufacturing barrier is process know-how. Public labeling generally does not disclose the exact PEO rheology, tablet density change, curing profile, or coating-pan operating conditions needed to evaluate claims 12, 13, 22, 23, and 24.

How does this patent compare with ordinary extended-release formulation patents?

Issue	Patent 9,763,933	Typical extended-release patent
Primary focus	PEO composition plus thermal curing	Composition or release profile
Active-agent scope	Broad in claim 1; opioid-specific in claim 11	Often molecule-specific
Manufacturing detail	Extensive	Often limited
Equipment limitation	Coating pan in dependent claims	Usually absent
Physical-property limitations	Density expansion and hardness	Sometimes absent
Design-around options	Polymer, process, loading, curing	Often narrower
Proof burden	High manufacturing-data burden	More dependent on formulation testing

The patent is strongest where the accused product uses the same high-PEO matrix and curing architecture. It is less dominant over extended-release products based on hydrophilic polymers other than PEO or on nonthermal manufacturing methods.

Key Takeaways

• Patent 9,763,933 covers high-PEO, solid oral extended-release dosage forms made by compression followed by heated-air curing without compression.
• Claim 11 is the principal opioid claim and requires at least 30% high-molecular-weight PEO, at least 1.3% opioid, and curing for at least 10 minutes at at least 60°C.
• Claims 12 through 30 add commercially relevant limitations involving coating-pan curing, cooling temperature, tablet expansion, hardness, additive identity, and total PEO loading.
• The patent is not limited to oxycodone. It expressly identifies buprenorphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, and morphine.
• The most important technical evidence is the PEO rheological molecular weight, polymer percentage, curing records, cooling profile, tablet density, and hardness.
• A design-around based solely on film coating is weak because film-coating weight is excluded from the dosage-form calculation.
• Orange Book status, patent expiration, Paragraph IV activity, litigation, and licensing cannot be established from the claim text alone.

FAQs

Does Patent 9,763,933 cover all opioid extended-release tablets?

No. The product must satisfy the claimed PEO concentration, molecular-weight, compression, heated-air curing, active-agent loading, and other limitations.

Can a tablet avoid the patent by using a film coating?

Not necessarily. The claims exclude film-coating weight from the dosage-form calculation. A coating does not remove the underlying composition from claim scope.

Is low-molecular-weight PEO required?

No. Low-molecular-weight PEO is optional in the relevant claims. The independent claims can apply without it.

Does curing in a conventional oven avoid the patent?

Not automatically. The claims require heated-air curing, but they do not universally require a coating pan. A conventional air-circulating oven may still present risk if the other limitations are met.

Can a manufacturer avoid the patent by using a different opioid?

Potentially, but not always. Claim 1 is not limited to opioids, while claim 11 and claim 14 contain opioid-specific coverage. The full claim language must be applied to the alternative active agent.

References

1. U.S. Patent No. 9,763,933. (2017). Pharmaceutical composition comprising polyethylene oxide and method of preparing same. United States Patent and Trademark Office.

2. U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.

3. U.S. Food and Drug Administration. (2024b). Applications covered by patents and exclusivity. Center for Drug Evaluation and Research.

4. United States Code, 35 U.S.C. §§ 101, 102, 103, 112, 154, 271, 282.

5. Code of Federal Regulations, 21 C.F.R. § 314.53.

Drugs Protected by US Patent 9,763,933

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes	9,763,933		Y
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No	9,763,933		Y
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No	9,763,933		Y
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No	9,763,933		Y
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	AB	RX	Yes	No	9,763,933		Y

International Family Members for US Patent 9,763,933

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062511
Argentina	103463
Argentina	109796
Argentina	109797
Austria	11571