Details for Patent: 11,097,006

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Which drugs does patent 11,097,006 protect, and when does it expire?

Patent 11,097,006 protects ARISTADA and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 11,097,006

Title:	Pharmaceutical compositions having improved storage stability
Abstract:	The present invention relates to a pharmaceutical composition that provides long-term stability of a hydrolytically labile antipsychotic agent
Inventor(s):	Jason M. PERRY, Daniel R. Deaver, Magali B. HICKEY, Julius F. Remenar, Jennifer VANDIVER, Michael J. Palmieri, JR., Zhengzheng Pan
Assignee:	Alkermes Pharma Ireland Ltd
Application Number:	US16/834,565
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,097,006
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 11,097,006: Aripiprazole Lauroxil Formulation Claims, Exclusivity, and Patent Landscape

US Patent 11,097,006 protects an aqueous injectable formulation of aripiprazole lauroxil, the prodrug used in Aristada and Aristada Initio. Its core protection is a high-concentration composition containing aripiprazole lauroxil, sorbitan laurate, polysorbate 20, and water, with a tightly controlled level of the aripiprazole hydrolysis product.

The patent is commercially significant because it targets formulation stability rather than the basic aripiprazole lauroxil molecule. A competing product may contain the same active ingredient yet avoid infringement if it uses different surfactants, different concentration ranges, a nonaqueous vehicle, or fails to meet the hydrolysis-product limitation.

What drug and formulation does US Patent 11,097,006 protect?

The claimed active ingredient, identified in the patent as Compound 1 or Compound I, is aripiprazole lauroxil. Its relevant hydrolysis product is aripiprazole.

Aripiprazole lauroxil is a covalent prodrug of aripiprazole designed for extended intramuscular release. Hydrolysis converts the prodrug into pharmacologically active aripiprazole. The patent addresses unwanted hydrolysis before administration, which can affect chemical purity, particle characteristics, dose uniformity, and product shelf life.

Patent element	Claimed requirement
Active ingredient	Aripiprazole lauroxil
Vehicle	Aqueous vehicle
Co-surfactant	Nonionic, water-insoluble or water-immiscible ester co-surfactant
Co-surfactant class	Sorbitan ester of a C4-C20 carboxylic acid
Soluble surfactant	Water-miscible or water-soluble nonionic surfactant
Preferred soluble surfactant	Polyoxyethylene derivative of a sorbitan ester
Narrow co-surfactant	Sorbitan laurate
Narrow soluble surfactant	Polysorbate 20
Active concentration in claim 6	About 20-30 wt%
Sorbitan laurate concentration	About 0.2-1 wt%
Polysorbate 20 concentration	About 0.1-0.3 wt%
Stability limitation	Less than 50 ppm hydrolysis product
Long-term stability limitation	Less than 30 ppm after at least 24 months

The claims are directed to a suspension or dispersion-type injectable composition rather than to a new chemical form of aripiprazole lauroxil.

How broad are the independent claims?

Claims 1 and 6 are the principal composition claims. Claim 1 is broader because it covers a range of sorbitan ester co-surfactants and water-soluble nonionic surfactants. Claim 6 is narrower but commercially more focused because it recites a specific excipient combination and concentration ranges.

Claim 1 scope

Claim 1 requires all of the following:

1. Aripiprazole lauroxil.
2. A nonionic, water-insoluble or immiscible ester co-surfactant.
3. The co-surfactant must be a sorbitan ester of a carboxylic acid containing 4-20 carbon atoms.
4. A water-miscible or water-soluble nonionic surfactant.
5. An aqueous vehicle.
6. Less than 50 ppm of the aripiprazole hydrolysis product.

The claim is composition-specific. It does not cover every aripiprazole lauroxil injectable formulation. A product lacking either the sorbitan ester or the water-soluble nonionic surfactant would fall outside the literal wording of claim 1.

The hydrolysis-product limitation is also substantive. A formulation that uses the same excipients but contains 50 ppm or more of the specified degradation product may not satisfy claim 1, subject to claim construction and infringement analysis.

Claim 6 scope

Claim 6 narrows the formulation to:

• 20-30 wt% aripiprazole lauroxil;
• approximately 0.2-1 wt% sorbitan laurate;
• approximately 0.1-0.3 wt% polysorbate 20;
• an aqueous vehicle; and
• less than 50 ppm hydrolysis product.

This claim is closely aligned with a commercial high-dose aripiprazole lauroxil injectable formulation. Its strength is commercial relevance. Its weakness is narrower literal coverage. A competing manufacturer could potentially design around the claim by changing the sorbitan ester, altering the polysorbate concentration, using another soluble surfactant, or moving outside the 20-30 wt% active range.

What do the dependent claims add?

Claims	Added limitation	Practical effect
2	Less than 30 ppm hydrolysis product after at least 24 months	Adds a long-term stability requirement
3	Polyoxyethylene sorbitan ester with a C8-C14 acid	Narrows the soluble surfactant class
4	Sorbitan laurate	Identifies the preferred immiscible co-surfactant
5	Polysorbate 20	Identifies the preferred water-soluble surfactant
7-8	Treatment of schizophrenia	Links the composition to an approved indication
9	Treatment of bipolar disorder	Adds a psychiatric method-of-use
10	Treatment of anxiety	Adds a psychiatric method-of-use
11	Treatment of depression	Adds a psychiatric method-of-use
12	Autism-related irritability	Adds a specific clinical use
13	Acute mania	Adds a specific clinical use
14-15	Specific hydrolysis-product structure	Defines the degradation product chemically

Claims 14 and 15 appear to depend on chemical structures that were omitted from the supplied claim text. Based on the active ingredient and known degradation pathway, the relevant hydrolysis product is aripiprazole. The exact claim construction should use the issued patent drawings and chemical structure rather than the abbreviated text.

What is the technical inventive concept?

The patent’s technical concept is the use of a two-surfactant system to stabilize a concentrated aqueous aripiprazole lauroxil formulation.

Sorbitan laurate is a lipophilic, water-insoluble or water-immiscible ester surfactant. Polysorbate 20 is a water-soluble polyoxyethylene surfactant. The combination is intended to support dispersion of a high loading of hydrophobic prodrug while reducing conversion to aripiprazole during storage.

The formulation architecture has four commercially relevant features:

• high active loading;
• an aqueous injectable vehicle;
• a defined interfacial surfactant system; and
• quantitative degradation control.

The 24-month limitation in claim 2 is particularly important. It is not merely a formulation recipe. It requires evidence that the composition remains below a specified degradation threshold after a defined period. In litigation, stability data, analytical methods, impurity identification, batch records, and long-term storage conditions would likely become central evidence.

How strong is the patent estate for aripiprazole lauroxil?

US 11,097,006 is strongest against products that replicate the commercial formulation closely. Its protection is weaker against products using a different delivery architecture.

Competitive design	Likely risk under US 11,097,006
Aripiprazole lauroxil with sorbitan laurate and polysorbate 20 in water	High
Same formulation with active loading of 20-30 wt%	High under claim 6
Same formulation but hydrolysis product above the claimed threshold	Reduced literal infringement risk
Aripiprazole lauroxil with polysorbate 80 instead of polysorbate 20	Potentially outside claims 5 and 6, but claim 1 requires separate analysis
Aripiprazole lauroxil with no sorbitan ester	Likely outside claim 1
Nonaqueous aripiprazole lauroxil formulation	Likely outside the composition claims
Aripiprazole monohydrate suspension	Outside the claimed prodrug formulation
Aripiprazole lauroxil implant or alternative depot system	Depends on excipients and vehicle
Oral aripiprazole product	Outside the composition claims

The patent does not independently block all generic aripiprazole lauroxil products. It primarily blocks a defined formulation strategy.

What is the Orange Book status of US 11,097,006?

US 11,097,006 is associated with the aripiprazole lauroxil injectable product family marketed by Alkermes, including Aristada-related formulations. Orange Book relevance depends on the specific NDA, product presentation, and whether the patent is listed against the applicable strength and dosage form.

The relevant FDA regulatory pathway is an NDA rather than an ANDA because aripiprazole lauroxil is a prodrug-based long-acting injectable product with formulation and delivery characteristics that are not necessarily replicated by an ordinary oral aripiprazole generic.

The principal FDA products are:

Product	Active ingredient	Dosage form	Sponsor
Aristada	Aripiprazole lauroxil	Extended-release injectable suspension	Alkermes
Aristada Initio	Aripiprazole lauroxil	Extended-release injectable suspension	Alkermes

Aristada was approved for the treatment of schizophrenia. Aristada Initio was approved as a one-time initiation dose used with oral aripiprazole or Aristada, subject to the approved labeling conditions.[1][2]

The Orange Book should be checked for the current listing status, patent-use codes, and any delisting or litigation-related updates. The patent’s commercial significance is highest where its listing covers the formulation used in a marketed product and an ANDA applicant must make a Paragraph IV certification.

When does US 11,097,006 lose exclusivity?

The patent issued on August 24, 2021. Its ordinary term is generally 20 years from the earliest effective nonprovisional or international application filing date, subject to patent-term adjustment and any applicable patent-term extension.

The precise expiration date cannot be determined from the claim text alone because it depends on the patent family’s priority chain, filing history, patent-term adjustment, and any terminal disclaimer. The patent is not an ordinary composition-of-matter patent with a simple expiration calculation based only on the issue date.

The commercial exclusivity timeline should be separated into three categories:

Exclusivity type	Relevance
New chemical entity exclusivity	Generally associated with the original active ingredient or regulatory product, not necessarily this later formulation patent
Regulatory exclusivity for the approved injectable	Depends on the FDA approval and product-specific exclusivity history
Patent exclusivity	Runs according to the statutory patent term and any adjustment or extension

Because US 11,097,006 issued years after the first approval of aripiprazole lauroxil, its principal role is formulation protection rather than basic active-ingredient exclusivity.

What Paragraph IV challenges and generic-entry risks exist?

A generic or follow-on applicant seeking approval for a substantially equivalent aripiprazole lauroxil injectable could face several certification and litigation issues:

1. Whether US 11,097,006 is listed for the reference product.
2. Whether the proposed formulation contains a sorbitan ester within the C4-C20 range.
3. Whether the proposed formulation contains a water-soluble nonionic surfactant.
4. Whether the product satisfies the concentration limitations in claim 6.
5. Whether the applicant can prove that its hydrolysis-product level is outside the claimed threshold.
6. Whether the proposed label induces use for a patented method of treatment.
7. Whether the product is submitted under an ANDA, a 505(b)(2) application, or another pathway.

A Paragraph IV certification would create litigation risk if the patent remains listed and the NDA holder receives the statutory notice. A successful timely patent action can trigger a 30-month stay of FDA approval under the Hatch-Waxman framework, subject to statutory exceptions and litigation outcomes.[3]

The most credible design-around strategy would likely be formulation-based rather than indication-based. Changing the co-surfactant or using a different vehicle may avoid the narrow claims, but the alternative must still meet injectable safety, particle-size, release, sterility, stability, and bioequivalence requirements.

Which companies challenge the aripiprazole lauroxil franchise?

The principal commercial competitors are companies selling other long-acting antipsychotic injectables, not necessarily direct aripiprazole lauroxil generics.

Product	Active ingredient	Sponsor	Competitive position
Aristada	Aripiprazole lauroxil	Alkermes	Direct reference product
Aristada Initio	Aripiprazole lauroxil	Alkermes	Initiation regimen
Abilify Maintena	Aripiprazole monohydrate	Otsuka/Lundbeck	Same active moiety, different prodrug and formulation
Perseris	Risperidone	Indivior	Long-acting subcutaneous antipsychotic
Uzedy	Risperidone	Teva	Extended-release subcutaneous product
Invega Trinza	Paliperidone palmitate	Janssen	Three-month injectable
Invega Hafyera	Paliperidone palmitate	Janssen	Six-month injectable
Rykindo	Risperidone	Luye	Long-acting injectable competitor

These products generally do not infringe US 11,097,006 because they use different active ingredients. They compete for the same long-acting schizophrenia market but do not present the same formulation patent risk.

What licensing and settlement issues matter?

The commercial record is dominated by Alkermes’ ownership and commercialization of aripiprazole lauroxil products. A license or settlement affecting US 11,097,006 would materially change generic-entry timing, but a definitive analysis requires the specific agreement, court docket, or FDA patent-listing record.

The key transaction questions are:

• whether Alkermes licensed aripiprazole lauroxil technology to another manufacturer;
• whether a settlement grants an authorized-generic launch date;
• whether the agreement includes a formulation carve-out;
• whether the license covers Aristada, Aristada Initio, or both;
• whether the agreement includes patent challenges or covenants not to sue.

No settlement should be inferred solely from the existence of a patent or from the absence of a publicly visible generic product.

What manufacturing and IP barriers does the patent create?

The patent creates several practical barriers beyond the written claims:

• reproducible manufacture of a high-concentration aqueous suspension;
• control of hydrolysis during bulk manufacture and filling;
• maintenance of particle-size distribution;
• consistent surfactant quality and impurity profiles;
• sterile processing of a viscous or particulate injectable;
• validated detection of aripiprazole at sub-50-ppm levels;
• long-term stability evidence supporting the 24-month limitation;
• clinical comparability for an extended-release injectable.

The analytical method is commercially important. A generic applicant would need a validated assay capable of distinguishing aripiprazole lauroxil from aripiprazole and quantifying the relevant hydrolysis product at the claimed thresholds.

How does US 11,097,006 compare with basic aripiprazole patents?

US 11,097,006 is narrower than a basic compound patent but potentially more durable as a commercial barrier if it covers the marketed formulation.

Patent category	Typical scope	Relevance to this patent
Compound patent	Aripiprazole or aripiprazole lauroxil molecule	Broader chemical protection
Depot-prodrug patent	Aripiprazole lauroxil and related prodrugs	Protects active pharmaceutical technology
Formulation patent	Surfactant, vehicle, concentration, stability	Core scope of US 11,097,006
Method-of-use patent	Schizophrenia or other psychiatric indications	Claims 7-13
Manufacturing patent	Particle formation, suspension preparation, filling	Separate barrier category
Regulatory exclusivity	FDA approval-based market protection	Distinct from patent term

Key Takeaways

• US 11,097,006 is a formulation patent for aqueous aripiprazole lauroxil injectable compositions.
• Its central excipient combination is sorbitan laurate plus polysorbate 20.
• Claim 6 is the most commercially focused claim because it recites the likely marketed concentration ranges.
• The hydrolysis-product limits are material claim elements, not merely quality specifications.
• The patent does not cover every aripiprazole lauroxil product or every long-acting antipsychotic injectable.
• A design-around may be possible through a different surfactant system, vehicle, concentration, or delivery platform.
• Generic-entry risk depends on Orange Book listing, the applicant’s regulatory pathway, Paragraph IV certification, and the exact formulation.
• Claims 14 and 15 require review of the issued chemical structures because those structures were omitted from the supplied claim text.
• The exact patent expiration date requires the complete priority and patent-term-adjustment record.

FAQs

Is US 11,097,006 a patent on aripiprazole itself?

No. It is directed primarily to a stabilized aqueous formulation containing aripiprazole lauroxil. It does not function as a basic compound patent covering all aripiprazole products.

Does a product using aripiprazole lauroxil automatically infringe this patent?

No. Infringement depends on the full formulation. The product must be compared with every limitation of the asserted claim, including the surfactant classes, aqueous vehicle, concentration ranges, and hydrolysis-product threshold.

Can polysorbate 80 avoid the patent?

It may avoid the narrower polysorbate 20 limitation, but it does not automatically avoid claim 1. The complete excipient system and the scope of the broader nonionic surfactant language must be assessed.

Do the schizophrenia method claims create separate generic-launch risk?

Yes. Claims 7 and 8 recite schizophrenia treatment using the claimed compositions. A generic applicant may need a label strategy that omits patented indications, although inducement and product-use evidence can still create litigation risk.

Is a biosimilar pathway relevant to Aristada?

No. Aristada is a small-molecule prodrug injectable, not a biologic. The more relevant pathways are an ANDA, a 505(b)(2) application, or another abbreviated pathway applicable to the proposed product.

References

1. U.S. Food and Drug Administration. (2015). Aristada: Aripiprazole lauroxil extended-release injectable suspension prescribing information.
2. U.S. Food and Drug Administration. (2018). Aristada Initio: Aripiprazole lauroxil extended-release injectable suspension prescribing information.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
4. United States Patent and Trademark Office. (2021). U.S. Patent No. 11,097,006: Pharmaceutical compositions comprising aripiprazole lauroxil.
5. Alkermes plc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Drugs Protected by US Patent 11,097,006

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-001	Oct 5, 2015		RX	Yes	No	11,097,006		Y			TREATMENT OF SCHIZOPHRENIA
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No	11,097,006		Y			TREATMENT OF SCHIZOPHRENIA
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-003	Oct 5, 2015		RX	Yes	Yes	11,097,006		Y			TREATMENT OF SCHIZOPHRENIA
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No	11,097,006		Y			TREATMENT OF SCHIZOPHRENIA

International Family Members for US Patent 11,097,006

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013349388
Canada	2885196
European Patent Office	2897592
European Patent Office	3718536
Spain	2792149
Hong Kong	1210033