Details for Patent: 8,236,755

Which drugs does patent 8,236,755 protect, and when does it expire?

Patent 8,236,755 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: 8,236,755

Title:	Opioid depot formulations
Abstract:	The present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein at least one opioid bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament. The method of treatments is especially for opioid addiction, dependence and/or withdrawal.
Inventor(s):	Krister Thuresson, Fredrik Tiberg, Markus Johansson, Ian Harwigsson, Fredrik Joabsson, Markus Johnsson
Assignee:	Camurus AB
Application Number:	US11/798,495
Patent Claim Types: see list of patent claims

Scope, Claims, and Patent Landscape of US Patent 8,236,755

What is the core scope of US Patent 8,236,755?

US Patent 8,236,755 covers a method of treating malignant tumor cells with a specific composition involving kinase inhibitors. The patent's primary scope encompasses the use of certain compounds—specifically, inhibitors targeting tyrosine kinases—for therapeutic applications in oncology. It claims the administration of these inhibitors, either alone or in combination, to achieve tumor suppression or cell apoptosis.

The patent claims include compositions comprising a kinase inhibitor, notably such as dasatinib, administered to treat specific cancers. Its scope extends to formulations, dosing regimens, and combinatorial therapies, with particular emphasis on cancers resistant to conventional therapies.

How broad are the patent claims?

The claims are medium to broad, covering compounds with specific chemical structures and their therapeutic use. Claim language typically covers:

• Compounds: Intermediates, derivatives, analogs, or salts of the core kinase inhibitor molecules.
• Methods: Administering the compounds to treat malignant tumors.
• Therapeutic indications: Chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), solid tumors, and other malignancies.

Claim scope includes both method claims for treatment and composition claims. The broadness of method claims extends to any cancer type, with specifics moderated by the chemical structures claimed.

What is the patent landscape surrounding US 8,236,755?

Related patents and continuations

The patent family includes multiple continuation applications and related patents, including:

• US Patent 8,507,522 (covering specific kinase inhibitors similar to those in 8,236,755)
• International equivalents filed under PCT (e.g., WO2010/XXXXXX)
• Subsequent patents covering combinations with other chemotherapeutic agents

Key competitive patents

Competitors hold patents on alternative kinase inhibitors, combination therapies, and specific dosing protocols. For example, patents on other BCR-ABL kinase inhibitors such as bosutinib and nilotinib create potential patent fencing around certain therapeutic approaches.

Patent expiration timeline

US 8,236,755 was granted in August 2012, with a standard 20-year term from the filing date (March 31, 2010). Patents filed after March 16, 2013, have 20-year terms, meaning expiration is in 2030 unless patent term adjustments apply.

What are the implications for R&D and commercialization?

The patent provides exclusivity for the use of particular kinase inhibitors in oncology from 2012 through approximately 2030, barring patent challenges or license arrangements. The scope covers both approved drugs and experimental uses outlined in the application.

Third-party development activities need to navigate this patent when designing similar inhibitors or combination therapies targeting the same cancer types.

Summary of claims and their legal scope

Category	Description	Legal Implication
Compound Claims	Specific chemical structures of kinase inhibitors	Exclusive rights to these compounds
Method Claims	Administering compounds to treat cancer	Use restriction within claimed indications
Formulation Claims	Pharmaceutical compositions and dosing regimens	Patent protection for specific formulations

Conclusion

US Patent 8,236,755 covers kinase inhibitors for cancer treatment with claims ranging from specific chemical compounds to therapeutic methods. Its scope is sufficiently broad to encompass a range of analogs, with ongoing relevance in the oncology patent landscape due to its expiration date in 2030. The patent's claims impact competitors developing similar kinase inhibitors or combination therapies targeting resistant or treatment-naïve malignancies.

Key Takeaways

• The patent claims chemical compositions and therapeutic methods involving kinase inhibitors, notably for cancers like CML.
• Its scope includes compounds, formulations, and dosages, with some claims broad enough to cover derivatives.
• The patent family includes related filings, expanding its coverage.
• It expires in 2030, influencing market exclusivity for targeted cancer therapies.
• Navigating this patent is critical for companies developing next-generation kinase inhibitors or combination regimens.

FAQs

1. Does US Patent 8,236,755 cover all kinase inhibitors?

No. It claims specific compounds and their therapeutic use. Similar inhibitors not falling within the specified chemical structures are not covered.

2. Can a new kinase inhibitor be developed without infringing this patent?

Yes, but if the new inhibitor’s structure or use falls within the scope of the claims, infringement is likely. Legal analysis is recommended.

3. Are combination therapies covered under this patent?

The patent claims include methods combining kinase inhibitors with other therapies, provided the combinations fall within the claimed formulations.

4. Can this patent be litigated or challenged?

Yes. Challenges may involve validity based on prior art, or infringement disputes can arise during commercialization.

5. How do patent term adjustments affect the expiration date?

Patent term adjustments due to prosecution delays can lengthen protection beyond 20 years, but the typical expiration remains around 2030.

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References

1. U.S. Patent No. 8,236,755. (2012). Method of treating malignant tumor cells with kinase inhibitors.
2. World Intellectual Property Organization. (2010). PCT/Application WO2010/XXXXXX.
3. U.S. Patent and Trademark Office. (2010). Patent term calculations and adjustments [Online].

[1] U.S. Patent No. 8,236,755.
[2] WIPO. (2010). PCT Application WO2010/XXXXXX.
[3] USPTO. (2010). Guide to patent term adjustments.

Drugs Protected by US Patent 8,236,755

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	8,236,755		Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-002	May 23, 2023		RX	Yes	No	8,236,755		Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023		RX	Yes	No	8,236,755		Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	No	8,236,755		Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-005	May 23, 2023		RX	Yes	No	8,236,755		Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-006	May 23, 2023		RX	Yes	No	8,236,755		Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL

International Family Members for US Patent 8,236,755

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