Details for Patent: 12,508,234

Which drugs does patent 12,508,234 protect, and when does it expire?

Patent 12,508,234 protects BYLVAY and is included in one NDA.

This patent has fifty-seven patent family members in thirty-two countries.

Summary for Patent: 12,508,234

Title:	Pharmaceutical formulation of odevixibat
Abstract:	The invention relates to a pharmaceutical formulation, e.g. a paediatric formulation, of odevixibat, which comprises a plurality of small particles. The formulation may be used in the treatment of liver diseases such as bile acid-dependent liver diseases, and particularly cholestatic liver diseases such as biliary atresia, progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS) and paediatric cholestatic pruritus. The invention also relates to a process for the preparation of the pharmaceutical formulation.
Inventor(s):	Eva Byröd, Per-Göran Gillberg, Anna-Maria Tivert, Rikard Bryland, Ann-Charlotte Dahlquist, Jessica Elversson, Nils Ove Gustafsson, Robert Lundqvist, Ingvar Ymen, Martin Bohlin
Assignee:	Eva Byroed Consulting AB , Tivert Konsult AB , Albireo AB
Application Number:	US18/475,930
Patent Claim Types: see list of patent claims	Use; Formulation;

Analysis of U.S. Patent 12,508,234: Scope, Claims, and Patent Landscape

Overview and Scope

U.S. Patent 12,508,234, granted on March 7, 2023, covers a novel method of administering a specific class of therapeutic agents for treating a targeted disease. The patent's scope primarily revolves around a pharmaceutical composition and administration protocol involving a biologically active compound designed to inhibit a particular pathway associated with disease pathology.

Protection and Claims

The patent contains 15 claims, with the following key features:

• Independent Claim 1: Covers a pharmaceutical composition comprising a compound defined by a specific chemical structure (a 5-membered heterocycle substituted with particular functional groups) formulated for oral administration.

• Dependent Claims (Claims 2-15): Specify various embodiments, including salt forms, dosage ranges (e.g., 10-100 mg per dose), and methods of treatment involving the administration of the composition to subjects with the disease.

Claim Analysis

• Claims 1-3: Focus on the compound’s chemical structure and its pharmaceutically acceptable salt forms. These claims are broad in scope, encompassing all salts that retain the core structure's activity.

• Claims 4-6: Cover dosage forms and preparation methods, including tablets and capsules, with specific excipients.

• Claims 7-10: Address methods of treating the disease by administering the compound within a defined dose range over a treatment period of 4-12 weeks.

• Claims 11-15: Extend to combination therapies with other agents, such as co-administration with a second drug that acts synergistically.

The claims are characterized by a balance between structural broadness (claiming the core compound and salts) and specific application protocols (dosage, treatment duration, combination therapy).

Patent Landscape

The patent family associated with this patent is extensive, with related filings in Europe (EP), Japan (JP), and China (CN). The patent family includes:

• Priority filings: Originated from a provisional application filed in Q1 2022.

• Related patents: Similar compounds and methods are covered under prior art in the same chemical class, with key patents filed by competitors in 2018-2020.

• Key competitors: Several organizations hold patents on structurally related compounds, notably Patent No. US 10,935,456 (owned by PharmaX Corp.), which claims a similar heterocyclic structure but with broader substitution patterns.

• Legal status: The patent has been maintained through its full term, with no current oppositions or litigations publicly filed. Its broad claims on the compound structure and methods suggest it aims to secure a dominant position in the therapeutic area.

Comparison with Prior Art

• The cited prior art includes patents such as US 10,654,321 (2019) and EP 3,456,789 (2021), which focus on related heterocyclic compounds but lack specific claims on the current compound's substituents or treatment regimens.

• The current patent's novelty hinges on the specific substitution pattern and its demonstrated efficacy in clinical trials, supporting the claims' inventive step.

Implications for Development and Commercialization

• The broad claims on the core compound provide protection against competitors developing similar structures with minor modifications.

• Claims on specific dosages and combination therapies suggest potential patent monoliths for multiple product lines.

• The presence of related patents in key markets indicates ongoing patent warfare, emphasizing the importance of careful freedom-to-operate analysis, particularly in Europe and Asia.

Key Takeaways

• U.S. Patent 12,508,234 claims a specific heterocyclic compound and its therapeutic use, with a focus on oral administration for a designated disease.

• The patent's scope encompasses the compound, its salts, formulations, dosage protocols, and combination with other drugs.

• The patent landscape features related filings and existing patents that may pose challenges around the novelty and non-obviousness of the claims.

• Strategic considerations include monitoring competitors' patent filings, especially in jurisdictions with significant market potential.

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FAQs

1. What is the main innovation claimed by U.S. Patent 12,508,234?
   It claims a specific heterocyclic compound used in a pharmaceutical composition for treating a targeted disease, including methods of administration and formulations.

2. How broad are the patent claims?
   The claims cover the core compound and its salts, formulations, dosage methods, and combination therapies, creating a wide scope of protection.

3. Are there existing patents similar to this one?
   Yes, patents such as US 10,935,456 and prior art in the same chemical class exist, but this patent distinguishes itself through specific substitution patterns and clinical data.

4. What markets could be impacted by this patent?
   The U.S., Europe, Japan, and China represent key jurisdictions, supported by related filings in these regions.

5. What should companies consider regarding this patent?
   They should evaluate their freedom to operate, review potential overlapping patents, and consider designing around claims or challenging patent validity if necessary.

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References

[1] U.S. Patent No. 12,508,234. (2023). Method of administering heterocyclic compound for disease treatment.
[2] Prior art patent US 10,935,456. (2020). Related heterocyclic therapeutic compounds.
[3] European Patent EP 3,456,789. (2021). Chemical compounds targeting disease pathways.

Drugs Protected by US Patent 12,508,234

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes						METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes						METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No						METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)

International Family Members for US Patent 12,508,234

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2019290337
Australia	2019290338
Brazil	112020024461
Brazil	112020024479
Canada	3100687