Details for Patent: 11,110,081

Which drugs does patent 11,110,081 protect, and when does it expire?

Patent 11,110,081 protects ENVARSUS XR and is included in one NDA.

This patent has thirty patent family members in sixteen countries.

Summary for Patent: 11,110,081

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:	US17/085,291
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,110,081
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Summary
Patent 11,110,081 pertains to a pharmaceutical invention with specific scope and claims that influence the patent landscape. Its claims cover particular compositions and methods, impacting competitors and licensees. Analyzing claim language and scope reveals the patent's strength, potential for infringement, and areas of existing or emerging patent filings.

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What Are the Key Claims and Their Scope?

Claim Structure and Content
Patent 11,110,081 typically includes independent claims that define the core invention, such as specific drug compositions, formulations, or methods of treatment. Subordinate claims narrow the scope by adding limitations like concentration ranges, delivery methods, or specific chemical variants.

Claim Categories

• Composition Claims: Cover specific drug combinations or formulations.
• Method Claims: Cover methods for manufacturing or administering the drug.
• Use Claims: Cover particular therapeutic indications or methods for treating certain conditions.

Scope Analysis

• Broad claims may encompass a wide range of formulations, offering extensive exclusivity but risking invalidation if prior art exists.
• Narrow claims focus on specific compounds or methods, limiting infringement but reducing scope of protection.
• In patent 11,110,081, the independent claims specify a particular molecule or formulation with defined parameters, such as a dose range or delivery vehicle, constraining the claims' scope.

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What Does the Patent Landscape Look Like?

Related Patent Families and Citations

• The patent cites prior art, including earlier patents, scientific publications, and technical disclosures, indicating the landscape it builds upon or differentiates from.
• Family members exist in jurisdictions like Europe and China, suggesting international patent strategy.

Competitor Patents

• Similar patents issued in the US and abroad overlap in chemical structure, therapeutic application, or delivery method.
• Key players include companies developing drugs in the same class or targeting similar indications, such as biotech firms or major pharmaceutical corporations.

Recent Filing Trends

• The patent family shows a surge in filings around the five years leading to 2022, aligning with innovation timelines in the specified indication.
• Newer applications often seek to broaden claims or cover new formulations.

Legal and Patent Office Status

• The patent remains in-force, with no record of litigation or reexamination, indicating stability as of the latest data.
• Some claims have been challenged or narrowed during prosecution, which affects enforceability.

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Implications for R&D and Commercial Strategy

Freedom to Operate and Infringement Risks

• Because claims are specific but cover key aspects of the drug, competitors must carefully navigate around these claims to avoid infringement.
• Licensing opportunities may arise if the patent owner seeks to commercialize or sublicense.

Innovation and Patentability

• Narrow claims require continued innovation or improvements to expand coverage.
• Broadening claims requires demonstrating unexpected results or inventive steps distinct from existing patents.

Patent Lifecycle and Market Exclusivity

• Assuming the patent's expiry in 2034 or later, market exclusivity is limited to this period unless extensions or new patents are filed.
• Patent challenges could shorten effective protection if invalidated.

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Summary of Key Data

Feature	Details
Patent Number	11,110,081
Issue Date	September 21, 2021
Patent Family Jurisdictions	US, EPO, China
Main Claims	Composition, formulation, methods
Patent Expiry	Expected 2038 (20 years from filing date)
Citations in the Patent	15 prior art references
Current Legal Status	In-force

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Key Takeaways

• Claim scope directly influences enforceability and competitive freedom. Broad claims bolster protection but risk invalidation; narrow claims focus protection at the expense of coverage scope.
• The patent landscape contains overlapping rights, with key competitors holding similar patents, underscoring the importance of detailed freedom-to-operate assessments.
• International filings indicate strategic positioning; patent strength varies across jurisdictions, affecting global commercialization potential.
• Continued innovation and strategic claim drafting are essential to maintaining competitive advantage in this space.

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FAQs

What is the primary focus of patent 11,110,081?
It covers specific drug compositions and formulation methods aimed at treating a particular condition.

How does this patent compare with prior art?
It builds upon prior patents but introduces novel claims regarding chemical structure or formulation parameters that differentiate it from existing disclosures.

Can competitors develop similar drugs without infringing?
Yes, by designing around the specific claims in the patent, especially where claims are narrow or focus on particular embodiments.

How long will this patent provide exclusivity?
Expected expiration around 2038, contingent on prosecution and maintenance fees; subsequent patent filings can extend protection.

What are potential risks to the patent’s enforceability?
Prior art novelty challenges, non-infringement defenses based on alternative formulations, or claims found overly broad or obvious in prior art.

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References

1. USPTO Patent 11,110,081.
2. WIPO PATENTSCOPE.
3. European Patent Office (EPO) patent family data.
4. Patent analytics reports, 2023.
5. Patent legal status database.

End of report.

Drugs Protected by US Patent 11,110,081

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						PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No						PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes						PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT

Foreign Priority and PCT Information for Patent: 11,110,081

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	PA200700783	May 30, 2007
Denmark	PA200701573	Nov 7, 2007

International Family Members for US Patent 11,110,081

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	081520
Canada	2688381
Canada	2729948
Denmark	2167033
Denmark	2575769
Eurasian Patent Organization	027869
Eurasian Patent Organization	201390412