Details for Patent: 12,161,640

Which drugs does patent 12,161,640 protect, and when does it expire?

Patent 12,161,640 protects BRIXADI and is included in one NDA.

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

Summary for Patent: 12,161,640

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:	US18/500,595
Patent Claim Types: see list of patent claims

Here is a detailed analysis of the scope, claims, and patent landscape for United States Patent 12,161,640:

Patent Overview

US Patent 12,161,640 is titled "Opioid formulations" and was granted to Braeburn Inc. in 2024. The patent relates to formulations containing buprenorphine for treating opioid addiction and pain management.

Key Claims

The key independent claims of this patent are:

1. A flowable composition suitable for injection, comprising:

   • Buprenorphine or a prodrug thereof
   • A biodegradable polymer
   • A biocompatible organic solvent

2. An implant formed in situ after injection of the flowable composition of claim 1.

3. A method of treating pain or opioid addiction comprising administering the flowable composition of claim 1 to a patient.

Scope Analysis

The claims are relatively broad in scope, covering:

• Various forms of buprenorphine (base, salts, prodrugs)
• A wide range of biodegradable polymers (e.g. PLGA, PLA, PCL)
• Multiple biocompatible organic solvents
• Both in situ forming implants and injectable formulations
• Use for both pain treatment and opioid addiction therapy

However, the claims are limited to:

• Buprenorphine as the active ingredient (not other opioids)
• Injectable/implantable formulations (not oral or transdermal)
• Biodegradable polymer matrix systems (not other depot technologies)

Patent Landscape

This patent appears to be part of a family of related patents owned by Braeburn Inc. covering their Brixadi (buprenorphine) extended-release injection product. Key aspects of the landscape include:

• Multiple related US patents (e.g. 11110084, 10912772, 9937164) with similar claims
• Patent protection extending to 2032 based on patent term
• Competing patents/products from Indivior (Sublocade) and Titan Pharmaceuticals (Probuphine)
• Growing market for long-acting buprenorphine formulations for opioid use disorder
• Ongoing patent litigation between Braeburn and Indivior over buprenorphine depot technologies

Analysis of Claim Scope

The independent claims use relatively broad language, likely providing a wide scope of protection:

• "Flowable composition" covers liquid, gel, and paste formulations
• No specific polymer or solvent is required, allowing flexibility
• Buprenorphine "prodrugs" expands beyond just the base compound
• Method claims cover both pain and addiction indications

However, some limitations narrow the scope:

• Restricted to buprenorphine/prodrugs (not other opioids)
• Requires biodegradable polymer (not other depot technologies)
• Limited to injectable/implantable routes of administration

Overall, the claims appear to provide broad coverage for injectable/implantable buprenorphine formulations using biodegradable polymers, while still being narrow enough to likely avoid prior art in other opioid delivery technologies.

Potential Vulnerabilities

Some potential weaknesses in the patent claims that competitors may try to exploit:

1. Lack of specific polymer/solvent combinations or concentrations
2. No pharmacokinetic parameters or release profiles specified
3. Broad functional language (e.g. "suitable for injection") with limited structural limitations
4. Potential obviousness arguments based on combining known elements

Conclusion

US 12,161,640 provides Braeburn with relatively broad patent protection for their extended-release buprenorphine technology. The claims cover key aspects of formulation and use while leaving some flexibility in specific compositions. This patent, along with related family members, likely provides strong protection for the Brixadi product through 2032, though there may be some opportunities for competitors to design around or challenge aspects of the claims.

Drugs Protected by US Patent 12,161,640

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
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-006	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 12,161,640

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E401054
Austria	E462409
Austria	E501710
Australia	2005249274
Australia	2005324794
Australia	2010202794