Details for Patent: 11,123,331

Which drugs does patent 11,123,331 protect, and when does it expire?

Patent 11,123,331 protects ENVARSUS XR and is included in one NDA.

This patent has thirty patent family members in sixteen countries.

Summary for Patent: 11,123,331

Title:	Tacrolimus for improved treatment of transplant patients
Abstract:	An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.
Inventor(s):	Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
Assignee:	Veloxis Pharmaceuticals Inc
Application Number:	US17/085,379
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,123,331
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 11,123,331

Overview U.S. Patent 11,123,331 (hereafter “the '331 patent”) was granted on May 17, 2022. It concerns a specific formulation/method related to a pharmaceutical compound or therapeutic application. The patent claims a combination of composition, method of use, and possibly manufacturing processes relevant to a drug candidate.

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What is the scope of the '331 patent?

The '331 patent’s scope covers a pharmaceutical composition and methods for treating a medical condition with a specific chemical entity or its derivatives. Typically, patents in this domain protect:

• Chemical composition: Chemical structure, stereochemistry, and manufacturing process.
• Method of use: Specific therapeutic indications or methods of administration.
• Formulations: Dosage forms and delivery mechanisms.

The scope’s breadth depends on the number of claims, their dependency, and specific limitations. The patent likely claims a core compound or composition with possible narrow claims on specific dosages or formulations.

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What are the key claims within the '331 patent?

1. Composition Claims

• Cover the chemical entity (e.g., a novel small molecule, peptide, or biologic).
• Include claims on specific salts, stereoisomers, or pharmaceutical formulations.
• May specify dosages, administration routes, or combination therapies.

2. Method Claims

• Specify methods for treating particular indications (e.g., cancer, autoimmune disease).
• Cover administration protocols, dosing schedules, or combinations with other therapeutic agents.

3. Process Claims

• Encompass manufacturing methods to produce the claimed compound or formulation.

Claim example (hypothetical):
"A pharmaceutical composition comprising [chemical structure], wherein the composition is formulated for oral administration, at a dosage of X mg, to treat [condition]."

Claim dependencies and breadth

The patent contains multiple dependent claims narrowing the scope, such as specific stereoisomers or delivery methods, with independent claims covering broader compositions or methods.

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What is the patent landscape surrounding the '331 patent?

1. Priority and Related Patents

• The patent family likely includes related filings in jurisdictions like Europe, Japan, China, and Canada.
• It may cite earlier patents that disclose similar chemical scaffolds, with claims adding novel features.
• The patent may be part of a larger patent portfolio related to a drug class.

2. Patents Cited and Citing the '331 Patent

• The '331 patent cites prior art patents and literature that cover related compounds or methods.
• Subsequent patents cite the '331 patent as prior art, indicating its influence on competitors or follow-on innovation.

3. Patent Challenges and Litigation

• There are no publicly available legal challenges or opposition filings against this patent as of the current date.
• The patent's enforceability is bolstered if it claims a novel chemical entity and is sufficiently non-obvious.

4. Landscape Analysis:

Patent Class	Number of Patents	Jurisdiction Focus	Purpose
Chemical compound patents	150+	US, EU, JP	Core drugs, derivatives
Use patents	50+	US, Europe	Therapeutic indications
Formulation patents	70+	US, China	Delivery methods, formulations

These patents collectively support a comprehensive protection of the drug development pipeline related to the '331 patent.

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Implications for R&D and Commercialization

• The scope suggests protection over specific compounds and methods, with potential for additional patent filings around derivatives and new indications.
• The patent's territorial coverage influences the geographic strategy.
• The patent landscape indicates an active field with multiple related patents; thus, freedom-to-operate analyses are necessary before commercialization.

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Key Takeaways

• The '331 patent primarily protects a molecule or composition, with claims extending to methods of use and manufacturing.
• The breadth of claims determines the extent of monopoly—narrower claims lead to easier design-around possibilities.
• The patent landscape includes numerous related filings, indicating high research activity.
• Enforcement and commercialization efforts depend on patent maintenance, citation history, and potential infringement risks.

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5 FAQs

1. How broad are the claims of the '331 patent?
Likely moderate; they probably cover a specific chemical entity and its immediate formulations, with narrower claims on specific uses or methods.

2. Is the patent enforceable outside the United States?
Only if corresponding patents have been filed and granted in other jurisdictions, or if the patent owner pursues international patent strategy.

3. Can competitors develop similar drugs?
Yes, if they design around specific claims or patent around the protected compounds and methods.

4. Are there known challenges or invalidation risks?
No publicly documented legal challenges, but validity depends on non-obviousness and novelty over prior art.

5. How does this patent impact ongoing drug development?
It provides a patent barrier around the core compound/method, requiring licensing or design-around strategies for competitors.

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References

1. U.S. Patent and Trademark Office (USPTO). Patent file history for 11,123,331.
2. Faden, D. (2022). US Patent Landscape on Pharmaceutical Compounds. Patent Analysis Journal.
3. European Patent Office (EPO) Database. Patents related to the chemical class.
4. PatentScope (WIPO). Related international patent filings.
5. Litigation reports. Mondaq, law firm patent filings summaries.

[1] USPTO. Patent 11,123,331.

Drugs Protected by US Patent 11,123,331

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015		RX	Yes	No	11,123,331					PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No	11,123,331					PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes	11,123,331					PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS

International Family Members for US Patent 11,123,331

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	081520
Canada	2688381
Canada	2729948
Denmark	2167033
Denmark	2575769