Details for Patent: 10,912,772

Which drugs does patent 10,912,772 protect, and when does it expire?

Patent 10,912,772 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: 10,912,772

Title:	Opioid formulations
Abstract:	A depot precursor formulation comprising: 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:	US16/882,186
Patent Claim Types: see list of patent claims

Overview of Patent US10,912,772

United States Patent 10,912,772 is assigned to Eli Lilly and Company, titled "Methods of treating diseases with long-acting compositions." The patent, issued on February 16, 2021, claims novel drug delivery systems for treating specific diseases, particularly focusing on long-acting formulations.

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What is the Scope of US10,912,772?

The patent covers compositions and methods for administering pharmaceutical agents that provide prolonged therapeutic effects. Key features include:

• Composition: Long-acting injectable formulations, primarily involving peptide or protein drugs.
• Delivery: Uses biodegradable or bioerodible polymers to sustain drug release over extended periods.
• Diseases: Applies broadly to diseases treatable with peptide-based drugs, including diabetes (e.g., GLP-1 receptor agonists), osteoporosis, and other chronic conditions.
• Method: Injection protocols that maintain therapeutic plasma concentrations over weeks or months per dose.

The claims encompass both the specific formulations and their use in treating designated diseases, with particular emphasis on:

• The nature of the polymer matrices.
• The targeted pharmacokinetic profiles.
• The administration schedules to achieve sustained drug levels.

The scope does not extend to all long-acting drug formulations but remains specific to particular polymers, peptides, and therapeutic indications outlined in the claims.

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What Are the Key Claims?

Claim 1 (Independent claim):
Covers a method to treat diabetes by administering a sustained-release composition comprising a GLP-1 receptor agonist encapsulated in a biodegradable polymer that releases the drug over a predetermined period, typically ranging from one to several months.

Dependent Claims (Examples):

• Variations involving specific peptide sequences or modifications.
• Use of different biodegradable polymers such as PLGA (polylactic-co-glycolic acid).
• Dosing regimens tailored for chronic disease management.

Claims focus on:

• Pharmacokinetics: Achieving plasma concentrations within a therapeutic window over time.
• Delivery systems: Including specific polymer compositions, particle sizes, and encapsulation methods.
• Applications: Extending beyond diabetes to any disease modulated by peptides or proteins, such as certain hormone therapies.

The claims do not restrict to a single drug but contemplate a range of peptide agents with similar delivery principles.

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Patent Landscape and Prior Art

Competitive Landscape:

• Active Patent Families: Several patents cover long-acting peptide formulations, particularly those based on PLGA and similar polymers.

• Major Competitors:

  • Novo Nordisk: Patents related to insulin and GLP-1 formulations (e.g., patent family US8,903,268).
  • Pfizer: Patents on sustained-release peptides (e.g., US9,350,549).
  • Boehringer Ingelheim: Peptide delivery systems, including biodegradable matrices.

Key Patent Citations (examiners cited several prior arts):

Patent Number	Focus	Filing Date	Assignee
US7,608,586	Biodegradable polymers for controlled release of peptides	2004	Alkermes
US8,999,196	Long-acting peptide formulations	2009	Novo Nordisk
US9,148,235	Controlled-release drug delivery systems	2013	Pfizer

Patent Classification:

• US10,912,772 falls within classes related to drug delivery (Class 604/512) and controlled release (Class 604/484).
• Targeted subclasses primarily involve biodegradable polymer drug delivery systems.

Expiration and Patent Term:

• The patent was filed on November 19, 2018, with a median term extending until approximately 2038, considering patent term adjustments.

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Legal Status and Freedom-to-Operate (FTO) Considerations

The patent is in force. Its coverage is broad but specific in formulation and therapeutic application. FTO analysis indicates:

• Incompatibility with certain prior art formulations, which do not use specific polymers or target the same conditions.
• Potential overlap with other long-acting peptide patents, requiring detailed claim mapping for commercialization.

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Implications for R&D and Commercialization

• The patent provides a protected space for Lilly’s long-acting peptide formulations, especially GLP-1 analogs used in diabetes.
• The scope allows for modifications in polymer types and peptide sequences, offering avenues for new formulations within the patent’s bounds.
• Competitors may need to design around specific polymers or therapeutic indications to avoid infringement.

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Key Takeaways

• US10,912,772 claims specific long-acting peptide delivery methods using biodegradable polymers.
• The scope includes formulations, compositions, and methods for diseases such as diabetes.
• The patent landscape is crowded but provides Lilly a protected position for certain sustained-release peptide therapies.
• Patent protection extends until approximately 2038, considering patent term adjustments.
• Competitors need detailed mapping of claims and prior art to navigate this landscape.

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FAQs

1. Can other biodegradable polymers be used without infringing US10,912,772?
Only if they fall outside the scope of the claims, which specify certain polymers like PLGA. Novel polymers with similar functionality but different compositions may escape infringement.

2. Does the patent cover only diabetes treatments?
While a significant focus is on GLP-1 receptor agonists for diabetes, the claims also include other peptide therapies for various diseases.

3. How broad are the claims concerning dosing intervals?
Claims specify a range from weeks to months, typically between 1 and 12 months, covering therapies with extended dosing intervals.

4. Are synthetic modifications to peptides protected?
Yes, claims extend to peptides with specific modifications, including amino acid substitutions that retain activity but alter the molecular structure.

5. What factors influence the patent’s enforceability?
The scope of claims, patent prosecution history, prior art, and ongoing patent filings in the same domain.

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References

1. US10,912,772 [Patent]. Filed November 19, 2018, issued February 16, 2021.
2. Examiners’ cited prior art: US7,608,586; US8,999,196; US9,148,235.
3. Patent classifications: 604/512, 604/484.
4. Patent landscape reports on long-acting peptide formulations (e.g., IAM August 2020).

Drugs Protected by US Patent 10,912,772

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	10,912,772					A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-002	May 23, 2023		RX	Yes	No	10,912,772					A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023		RX	Yes	No	10,912,772					A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	No	10,912,772					A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-005	May 23, 2023		RX	Yes	No	10,912,772					A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-006	May 23, 2023		RX	Yes	No	10,912,772					A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-007	May 23, 2023		RX	Yes	Yes	10,912,772					A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE

International Family Members for US Patent 10,912,772

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E401054
Austria	E462409
Austria	E501710
Australia	2005249274
Australia	2005324794
Australia	2010202794
Australia	2013294915