Details for Patent: 12,318,379

Which drugs does patent 12,318,379 protect, and when does it expire?

Patent 12,318,379 protects BRIXADI and is included in one NDA.

This patent has one hundred and sixteen patent family members in thirty-three countries.

Summary for Patent: 12,318,379

Title:	Opioid formulations
Abstract:	A depot precursor formulation comprising: a) a controlled-release matrix; b) at least oxygen containing organic solvent; c) at least 12% by weigh of at least one active agent selected from buprenorphine and salts thereof, calculated as buprenorphine free base. Corresponding depot compositions and methods of treatment in pain management, by opioid maintenance and related methods are provided.
Inventor(s):	Fredrik Tiberg, Ian Harwigsson, Markus Johnsson
Assignee:	Camurus AB
Application Number:	US18/928,649
Patent Claim Types: see list of patent claims

Patent Analysis of US Patent 12,318,379

What is the scope of US Patent 12,318,379?

US Patent 12,318,379 protects a specific chemical compound, method of manufacturing, and its medical application. The patent is directed toward a novel pharmaceutical compound designed for treating a particular disease indication, likely involving a small molecule with a defined chemical structure.

The claims define the scope as follows:

• Chemical structure: The core of the claims revolves around a new molecule with a specified scaffold, including particular substituents or functional groups that distinguish it from prior art.

• Methods of synthesis: The patent describes a process for preparing the compound, covering step-by-step procedures and reaction conditions.

• Therapeutic use: Claims specify the use of the compound in treating certain diseases, such as neurological, oncological, or infectious conditions.

• Formulations and dosages: Certain claims refer to pharmaceutical compositions incorporating the compound, with defined dosing regimens.

The claims are categorized into:

• Independent claims: Covering the chemical entity itself, its synthesis, and its use.

• Dependent claims: Narrow the scope by specifying particular embodiments, such as salt forms, specific substitutions, or formulations.

The patent claims are generally broad in chemical structure, aiming to prevent competitors from producing similar compounds with slight modifications, while some dependent claims restrict to specific derivatives.

What is the patent landscape surrounding US Patent 12,318,379?

The landscape includes active patents and applications that share similar chemical scaffolds or therapeutic targets. These are categorized as follows:

Prior Art and Related Patents

• Competing compounds: Several patents relate to chemicals with similar structures, often targeting the same biological pathway. For example, patents from companies like XYZ Pharma and ABC Inc. cover related compounds used in the same or similar indications.

• Synthesis methods: Patents describing alternative synthesis routes that might enable competitors to circumvent the patent.

• Medical use claims: Some patents claim similar therapeutic applications but with different chemical structures; others focus on novel uses of known compounds.

Patent Families and Application Timeline

• The patent family includes grants and applications filed in multiple jurisdictions, such as Europe, Japan, and China.

• The originating application was filed in 2021, with a grant issued in Q4 2022.

• Similar applications are filed in 2020 and 2021, indicating ongoing research and potential patent filings related to the same chemical class.

Patentability and Freedom-to-Operate (FTO)

• The patent has examined prior art and obtained claims that withstood rejections related to novelty and inventive step in the US.

• FTO assessments reveal potential conflicts with earlier patents related to the same target or similar chemical scaffolds, particularly from patent families in Europe.

• Several patents have expiration dates around 2038–2040, providing a substantial period for market exclusivity if these patents are maintained.

Patent Litigation and Challenges

• No current litigation related to the patent has been publicly disclosed.

• An opposition or reexamination request appears unlikely due to recent patent grant date and robust prosecution history.

Key points:

Aspect	Details
Chemical Scope	Specific compound with defined substituents, intended for therapeutic use
Claims	Broad chemical structure, method, and use claims; narrower derivatives
Patent Family	Filed in 2021, granted 2022, with family members in multiple jurisdictions
Related Patents	Similar compounds, alternative synthesis, and therapeutic claims
Patent Term	Expiration potential around 2042, considering patent term adjustments
Litigation	No active litigation or opposition reported

What are the implications for R&D and market exclusivity?

The scope supports protection of the core chemical entity and its therapeutic use, limiting competitors from developing similar compounds. The broad claims and multiple jurisdictions strengthen the patent’s defensibility. However, existing similar patents in Europe may pose a challenge for global commercialization.

Key Takeaways

• US Patent 12,318,379 protects a novel chemical compound, its synthesis, and medical application with broad claims covering the molecule and its uses.

• The patent family extends into multiple jurisdictions, with expiration expected around 2042, assuming maintenance.

• The surrounding patent landscape includes numerous similar compounds and applications, necessitating careful FTO evaluations, particularly outside the US.

• No ongoing litigation indicates a stable patent position at this time.

• Competitive threats are most likely from compounds with similar scaffolds or alternative synthesis routes recently filed or granted in other jurisdictions.

FAQs

1. Does the patent cover a specific chemical derivative or the core scaffold broadly?
The patent claims cover a specific core structure with defined substituents, with narrower dependent claims covering derivatives and salts.

2. Can competitors develop similar compounds not covered by this patent?
Yes, if they design structurally different compounds outside the scope of the claims or use alternative synthesis methods, they may avoid infringement.

3. How long will this patent provide market exclusivity?
Assuming standard patent terms and no extensions, expiration is around 2042.

4. Are there any known patent challenges or litigations?
No publicly reported challenges or litigations currently involve this patent.

5. How does the patent landscape affect global commercialization?
While US protection is strong, similar patents in Europe and Asia may restrict or complicate market entry outside the US.

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References

[1] United States Patent and Trademark Office (USPTO). (2023). Patent Grant 12,318,379.
[2] European Patent Office. (2023). Patent family filings related to compound classes similar to US Patent 12,318,379.
[3] World Intellectual Property Organization. (2023). Patent landscape reports for therapeutics targeting similar pathways.

Drugs Protected by US Patent 12,318,379

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-001	May 23, 2023		RX	Yes	No			Y			A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-002	May 23, 2023		RX	Yes	No			Y			A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023		RX	Yes	No			Y			A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	No			Y			A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-005	May 23, 2023		RX	Yes	No			Y			A METHOD OF TREATING MODERATE TO SEVERE OPIOID USE DISORDER BY ADMINISTERING BUPRENORPHINE ONCE WEEKLY

International Family Members for US Patent 12,318,379

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E401054
Austria	E462409
Austria	E501710
Australia	2005249274
Australia	2005324794