Details for Patent: 9,592,200

Summary for Patent: 9,592,200

Title:	Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Abstract:	An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In a preferred embodiment, a drug is modified to increase its lipophilicity. In some embodiments the modified drug is homogeneously dispersed within spherical microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and/or organic solvent insoluble. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.
Inventor(s):	Roman V. Rariy, Alison B. Fleming, Jane Hirsh, Alexander M. Klibanov
Assignee:	Collegium Pharmaceutical Inc
Application Number:	US14/946,275
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,592,200
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

US Patent 9,592,200: Oxycodone Fatty-Acid Microparticle Patent Scope, Expiration and Competitive Landscape

US Patent 9,592,200 protects an abuse-deterrent oral oxycodone dosage form built from microparticles containing oxycodone and excess fatty acid, with the oxycodone present as a fatty-acid salt. Its broadest product claim requires a fatty-acid-to-oxycodone molar ratio above approximately 7:1 and a homogeneous single-phase microparticle. The patent also covers manufacturing the microparticles by dissolving oxycodone free base in a hot fatty-acid melt.

The patent is part of the patent estate associated with Collegium Pharmaceutical's Xtampza ER oxycodone extended-release capsules. Its commercial importance comes from the combination of formulation structure, salt chemistry, particle architecture and abuse-deterrence performance.

What does US Patent 9,592,200 protect?

The patent has two independent claims:

Claim	Category	Core subject matter
1	Composition	Abuse-deterrent oral dosage form containing multiple microparticles with oxycodone and fatty acid
19	Manufacturing method	Dissolving oxycodone free base in a hot-melt fatty-acid solution at a ratio above approximately 7:1

Claim 1 is the principal product claim. It requires all of the following:

1. An oral dosage form.
2. A plurality of microparticles.
3. Each microparticle has a homogeneous single phase.
4. Each microparticle contains oxycodone.
5. Each microparticle contains one or more fatty acids.
6. The fatty-acid-to-oxycodone molar ratio is in excess of about 7:1.
7. The oxycodone is in the form of a fatty-acid salt.

A product that lacks any one of these limitations would not literally satisfy claim 1. The claim does not require a capsule, tablet, controlled release, enteric coating or specific fatty acid unless those limitations are added through dependent claims.

What is the importance of the homogeneous single-phase limitation?

The homogeneous single-phase requirement distinguishes the claimed microparticle from a conventional multiparticulate system in which oxycodone crystals, coated particles or separate excipient domains are dispersed in a carrier.

The limitation points toward a solid or semi-solid matrix in which the drug and fatty acid are integrated into a substantially uniform phase. This limitation may create both technical and litigation significance:

• A product with visible or microscopic phase separation may avoid literal infringement.
• A product with a uniform drug-fatty-acid matrix is more likely to fall within the claim.
• The claim does not expressly define the analytical method for determining homogeneity or phase number.
• Disputes may focus on microscopy, thermal analysis, spectroscopy, dissolution behavior or manufacturing records.

The phrase "single phase" is narrower than merely requiring fatty acid to be present in the dosage form. A formulation containing oxycodone in one phase and fatty acid in another may present a noninfringement position, subject to the patent's specification and claim-construction record.

Which fatty acids are covered by US 9,592,200?

Claim 1 uses the broader expression "one or more fatty acids." Dependent claims identify particular fatty acids.

Claim	Fatty-acid coverage
1	Broad, not limited to a named fatty acid
2	Linoleic, octanoic, lauric, stearic, palmitic, myristic or oleic acid
3	Stearic, palmitic or myristic acid
4	Myristic acid
9	Myristic acid with beeswax, carnauba wax or both
20	Same named fatty acids in the manufacturing method
21	Stearic, palmitic or myristic acid in the manufacturing method
22	Myristic acid in the manufacturing method

The broad independent claim is not expressly limited to the seven fatty acids listed in claim 2. Claim 2 therefore operates as a narrower species claim, while claim 1 potentially reaches other fatty acids if the remaining limitations are satisfied.

The patent's strongest formulation position appears to be the combination of oxycodone, myristic acid and a wax carrier. Claim 9 narrows the formulation to myristic acid plus beeswax, carnauba wax or a mixture of the two.

What formulations are protected by the dependent claims?

Claims 2 through 18 create a layered formulation estate.

Claims	Protected feature
2-4	Specific fatty acids, ending with myristic acid
5-9	Carrier materials, including fats, waxes, beeswax and carnauba wax
10-11	Tablet or capsule dosage forms, with claim 11 limited to capsules
12-13	Antioxidants, including BHT, BHA, tocopherol, ascorbic acid, citric acid and propyl gallate
14	Enteric coating on each microparticle
15	Controlled-release oral dosage form
16	Pharmaceutically acceptable surfactant
17	Spherical microparticles
18	Release-retardation performance after physical compromise and immersion in water

Claims 14 through 17 are technically important because they address common design variables in multiparticulate drug products. They may cover commercial implementations that use coated, spherical, controlled-release particles even where a competitor disputes the broader claim's construction.

Claim 18 is a functional abuse-deterrence limitation. It requires the dosage form to retard release of the abuse-prone drug after the physical integrity of the dosage form is compromised and the compromised product is placed in water. The claim therefore addresses tampering conditions rather than only intact oral administration.

How does the manufacturing method in claim 19 work?

Claim 19 requires a method in which:

• Oxycodone is used in free-base form.
• The free base is dissolved in a hot-melt solution.
• The hot-melt solution contains one or more fatty acids.
• The fatty-acid-to-oxycodone molar ratio exceeds approximately 7:1.
• The method produces the dosage form of claim 1.

This claim captures a manufacturing route rather than merely the final product. The distinction between starting material and final-state chemistry is important. The method starts with oxycodone free base, while claim 1 requires the final oxycodone to be in the form of a fatty-acid salt.

Potential infringement analysis would examine:

• Whether the process uses oxycodone free base.
• Whether the drug is dissolved rather than merely dispersed.
• Whether the process qualifies as a hot-melt solution.
• Whether the ratio is above 7:1.
• Whether the resulting particles have a homogeneous single phase.
• Whether the final drug is chemically present as a fatty-acid salt.

A manufacturer using a preformed oxycodone salt, a solvent-based process, or a process that produces a multiphase dispersion may have arguments against literal infringement of claim 19. Those arguments would not necessarily resolve infringement of claim 1.

What is the patent expiration date for US 9,592,200?

US Patent 9,592,200 was issued on March 14, 2017. Its term is tied to the relevant US nonprovisional priority and patent-term-adjustment calculations. Public patent and FDA listing records associate the patent family with an expiration in approximately 2029, subject to the official term calculation and any applicable patent-term adjustment or extension.[1][2]

Event	Date or status
Patent	US 9,592,200
Issue date	March 14, 2017
Patent type	Utility patent
Commercial association	Xtampza ER oxycodone extended-release capsules
Expected term endpoint	Approximately 2029
Regulatory significance	Listed Orange Book patent for an oxycodone drug product estate

The patent does not receive new chemical entity exclusivity. Its commercial blocking period is based primarily on patent rights and the broader Xtampza ER patent portfolio.

What is the Orange Book status of US 9,592,200?

FDA Orange Book listings identify patent rights that a generic applicant must address when filing an ANDA for the corresponding reference-listed drug. Collegium's Xtampza ER labeling and FDA product records identify multiple patents covering the product's formulation and use.[2][3]

US 9,592,200 is relevant to Xtampza ER because its claims correspond to the product's abuse-deterrent oxycodone multiparticulate technology. The patent should be analyzed together with the other listed Xtampza ER patents rather than as a standalone exclusivity right.

The Orange Book does not establish infringement. It identifies patents that may require a Paragraph I, II, III or IV certification:

• Paragraph I: no patent information is listed.
• Paragraph II: the listed patent has expired.
• Paragraph III: the applicant will not market before patent expiration.
• Paragraph IV: the applicant alleges that the patent is invalid, unenforceable or not infringed.

A Paragraph IV certification may trigger patent litigation under the Hatch-Waxman Act. The filing of an ANDA does not itself prove that the proposed generic infringes US 9,592,200.

When does Xtampza ER lose exclusivity?

Xtampza ER received FDA approval in 2016 as an abuse-deterrent extended-release oxycodone product.[3] Its five-year new chemical entity exclusivity period expired in 2021. Patent-based protection is more important than regulatory exclusivity for the commercial timing of generic entry.

The principal timing framework is:

Protection	Approximate status
FDA approval	2016
Five-year NCE exclusivity	Expired in 2021
US 9,592,200	Expected to remain relevant through approximately 2029
Generic entry	Subject to listed-patent certifications, litigation and any settlement terms

A generic applicant could pursue an ANDA before patent expiration using a Paragraph IV certification. Actual launch timing would depend on litigation outcomes, a court-imposed stay, settlement provisions, other listed patents and regulatory approval.

Which companies are challenging the Xtampza ER patent estate?

Public ANDA litigation and settlement records must be assessed across the full Xtampza ER patent portfolio. A challenge directed to one patent does not remove the commercial barrier created by other listed patents.

The relevant competitor categories include:

• Large generic companies filing oxycodone extended-release ANDAs.
• Specialty generic companies developing abuse-deterrent multiparticulates.
• Licensees or partners using alternative controlled-release matrices.
• Developers pursuing 505(b)(2) products with modified formulations or delivery technologies.

The most important legal issue is claim overlap across the portfolio. A generic applicant may avoid US 9,592,200 while still facing other formulation, manufacturing, particle-coating or method-of-use patents. Conversely, invalidation or noninfringement of this patent would not necessarily authorize immediate launch.

How strong is the patent estate for US 9,592,200?

The patent has meaningful technical breadth but several potentially contestable limitations.

Strengths

• Claim 1 is directed to the final product, making process differences less important.
• The claim covers a broad class of fatty acids.
• The ratio above 7:1 creates a measurable formulation limitation.
• The claim combines drug chemistry and particle morphology.
• Dependent claims create fallback positions around myristic acid, waxes, capsules, controlled release and spherical particles.
• Claim 19 provides a separate process-based enforcement theory.

Vulnerabilities

• "Homogeneous single phase" may require extensive factual and analytical proof.
• "Fatty-acid salt" may generate disputes over the required degree of ionization or chemical characterization.
• "In excess of about 7:1" raises questions concerning measurement, rounding and batch variability.
• Claim 18's performance limitation may depend on the test conditions used to assess tampered release.
• Prior art involving opioid-lipid matrices, fatty-acid salts, hot-melt processing and abuse deterrence may be relevant to validity.
• A competing formulation may use a different particle architecture or maintain oxycodone and fatty acid in separate phases.

The estate is strongest when the accused product uses the same core design: oxycodone embedded in a uniform fatty-acid microparticle at a high fatty-acid ratio, particularly with myristic acid and wax carriers.

How does US 9,592,200 compare with alternative oxycodone technologies?

Technology	Core design	Relationship to US 9,592,200
Xtampza ER	Oxycodone extended-release multiparticulates using abuse-deterrent lipid-based technology	Closest commercial technology
OxyContin	Controlled-release oxycodone tablet with abuse-deterrent polymer matrix	Different dosage-form architecture
Conventional oxycodone ER generic	Matrix or coated tablet/capsule	May avoid microparticle and fatty-acid-salt limitations
505(b)(2) lipid formulation	Modified lipid or multiparticulate delivery system	Risk depends on phase structure and salt chemistry
Non-oral or implantable system	Alternative route of administration	Generally outside the oral dosage-form claims

The patent does not cover every abuse-deterrent oxycodone product. It is directed to a specific multiparticulate lipid formulation and a related hot-melt manufacturing process.

What generic launch risks exist?

A generic developer faces four principal risks:

1. Product-claim risk. The proposed product may contain the required homogeneous oxycodone-fatty-acid phase.
2. Process-claim risk. The manufacturing process may begin with oxycodone free base and use the claimed hot-melt ratio.
3. Portfolio risk. Other Xtampza ER patents may remain enforceable even if US 9,592,200 is avoided.
4. Regulatory equivalence risk. An ANDA applicant must demonstrate bioequivalence and address the reference product's abuse-deterrent characteristics.

Design-around strategies may include using a non-fatty-acid matrix, a different drug-excipient phase structure, a non-hot-melt process, a different ratio, a preformed salt, or a dosage form that does not use the claimed microparticle architecture. Each strategy can affect dissolution, abuse-deterrence performance, bioequivalence and manufacturability.

Does US 9,592,200 create biosimilar risk?

No. Biosimilars apply to biological products, while oxycodone is a small-molecule drug. The relevant competitive pathway is an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act, or in some cases a 505(b)(2) application.[4]

Key Takeaways

• US 9,592,200 covers oxycodone fatty-acid microparticles with a homogeneous single phase.
• The central quantitative limitation is a fatty-acid-to-oxycodone molar ratio above approximately 7:1.
• Claim 1 requires oxycodone to be present as a fatty-acid salt.
• The patent reaches both final dosage forms and a hot-melt manufacturing process.
• Myristic acid, wax carriers, capsules, spherical particles and controlled release are protected through dependent claims.
• The patent is commercially associated with Xtampza ER and is expected to remain relevant through approximately 2029.
• The main design-around opportunities involve phase structure, salt formation, fatty-acid ratio and manufacturing route.
• Biosimilar law is irrelevant; generic competition proceeds through the ANDA and Paragraph IV framework.
• A challenge to this patent alone would not eliminate the broader Xtampza ER patent barrier.

FAQs About US Patent 9,592,200

Does claim 1 require extended release?

No. Claim 1 does not require controlled release. Extended release is added by dependent claim 15.

Does claim 1 require a capsule?

No. Claim 1 covers an oral dosage form generally. Claim 10 identifies capsules or tablets, and claim 11 narrows the form to a capsule.

Is myristic acid required?

No. Claim 1 is not limited to myristic acid. Myristic acid is added through dependent claims 4, 9 and 22.

Can a product infringe without using a hot-melt process?

Yes. Claim 1 is a product claim and does not require the manufacturing process in claim 19. A product could potentially infringe claim 1 even if manufactured by another process.

Does a Paragraph IV filing invalidate US 9,592,200?

No. A Paragraph IV certification is an allegation that the patent is invalid, unenforceable or not infringed. The patent remains enforceable unless it expires, is disclaimed, is invalidated or is otherwise removed from the relevant dispute.

References

1. United States Patent and Trademark Office. (2017). U.S. Patent No. 9,592,200, abuse-deterrent oral dosage forms.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2016). Xtampza ER prescribing information. Collegium Pharmaceutical, Inc.
4. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application (ANDA) process.

Drugs Protected by US Patent 9,592,200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 9,592,200

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003247876
Canada	2491572
Canada	2569958
Canada	2916869
Cyprus	1119831
Denmark	1765292