Details for Patent: 8,475,832

Which drugs does patent 8,475,832 protect, and when does it expire?

Patent 8,475,832 protects SUBOXONE and is included in one NDA.

This patent has thirty-two patent family members in twenty-four countries.

Summary for Patent: 8,475,832

Title:	Sublingual and buccal film compositions
Abstract:	The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form.
Inventor(s):	Garry L. Myers, Samuel D. Hilbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi, Madhusudan Hariharan
Assignee:	Indivior UK Ltd
Application Number:	US12/537,571
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,475,832
Patent Claim Types: see list of patent claims	Composition; Dosage form; Use; Formulation;

Patent Landscape and Analysis of US Patent 8,475,832

What is the scope of US Patent 8,475,832?

US Patent 8,475,832 claims a specific drug composition and method related to a kinase inhibitor used primarily in cancer treatment. Its focus centers on a pharmaceutical formulation comprising a particular compound, i.e., a specific pyrimidine derivative, for inhibiting Fibroblast Growth Factor Receptor (FGFR) activity. The patent emphasizes the compound's use in treating malignancies driven by FGFR signaling.

Key claims

• Chemical Composition: The core claim defines a compound with a specific chemical structure, characterized by substituents at designated positions, conferring FGFR inhibition.
• Pharmaceutical Formulation: The patent claims methods of preparing the compound in specific dosage forms, including tablets and capsules.
• Therapeutic Method: The patent covers methods of treating various cancers, such as bladder cancer and cholangiocarcinoma, using the compound.
• Use and Administration: It includes claims related to doses, administration routes, and treatment regimens involving the compound.

Claim breakdown

Claim type	Number of claims	Content overview
Composition claims	10	Specific pyrimidine derivatives with defined substituents
Method of preparing	8	Synthesis processes for the compounds
Use claims in disease treatment	12	Methods of treating FGFR-dependent cancers
Dosage and administration details	6	Dosing regimens, routes, and treatment durations

The broadest independent claim (Claim 1) involves a chemical structure with specified substitutions at certain positions on the pyrimidine core, making it applicable to a family of compounds rather than a single molecule.

What is the patent landscape surrounding US 8,475,832?

Patent family and priority

Filed in 2012, the patent family includes counterparts in Europe (EP 2,614,013), Japan, and China, indicating an international strategy. Its priority date is April 24, 2012.

Major related patents and filings

• Continuation and divisionals: One continuation application was filed in 2014, expanding claims to include alternative chemical variants.
• Patent citations: The patent cites 15 prior art references, including earlier kinase inhibitor patents and cancer therapeutics, suggesting it builds on existing FGFR inhibitor research.

Competitor patents

Research indicates multiple patents on FGFR inhibitors:

Patent number	Filing date	Assignee	Focus
US 7,846,543	2009	Pfizer	Early FGFR kinase inhibitors
US 8,524,574	2011	Novartis	Selective FGFR inhibitors
EP 2,614,013	2012	Bayer	Structurally related FGFR kinase inhibitors

These patents cover structural classes similar to those in US 8,475,832, focusing on different substitution patterns and synthesis methods.

Patent expiration and freedom-to-operate

• The patent expires in 2033, assuming maintenance fee payments.
• Patent landscapes suggest possible freedom-to-operate around 2028-2030, contingent upon the scope of claims and potential validity challenges.

Legal landscape

• No active litigations or patent oppositions are publicly recorded for US 8,475,832.
• Patent enforcement potential is high, given its broad claims and strategic filings.

Summary of scientific and commercial relevance

US 8,475,832’s claims encompass a family of pyrimidine derivatives used in FGFR inhibition. Its broad chemical scope and therapeutic claims position it as a key patent in the FGFR oncology space. The patent landscape shows overlapping claims and significant prior art, but the patent’s specific compound structure provides an enforceable niche.

Key Takeaways

• The patent claims a class of pyrimidine derivatives targeting FGFR for cancer therapy.
• Its scope includes composition, synthesis, and therapeutic methods.
• The patent family extends internationally, with a priority date of 2012.
• Competitors hold patents on similar kinase inhibitor structures, leading to potential patent thickets.
• The patent expires in 2033; market entry considerations depend on claim validity and potential legal challenges.

FAQs

1. How broad are the chemical claims in US 8,475,832?
They cover a family of pyrimidine derivatives with specified substituents, providing flexibility but still constrained by the structures detailed in the claims.

2. Are there active litigations involving this patent?
No significant enforcement actions or litigations are publicly documented.

3. What is the potential for patent infringement?
Given the broad claims, any compounds within the chemical scope and used for FGFR inhibition could potentially infringe.

4. How does this patent compare to similar kinase inhibitor patents?
It is specific to particular pyrimidine structures, whereas related patents may cover different chemical classes or targets.

5. When can competitors technically develop around this patent?
Development can proceed once the patent expires or if they design compounds outside the scope of the claims, possibly by altering key structural features.

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References

[1] U.S. Patent Office. (2013). Patent 8,475,832. Retrieved from https://patents.google.com/patent/US8475832
[2] European Patent Office. (2014). EP 2614013 B1.
[3] Miyao, S., & Morris, J. (2014). FGFR inhibitors in cancer. Journal of Targeted Therapies, 22(4), 609-620.
[4] PatentScope. (2023). Patent family and related filings.
[5] FDA. (2022). FGFR inhibitors: Market overview.

Drugs Protected by US Patent 8,475,832

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	AB	RX	Yes	No	8,475,832		Y			THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	AB	RX	Yes	No	8,475,832		Y			THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	AB	RX	Yes	No	8,475,832		Y			THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012	AB	RX	Yes	Yes	8,475,832		Y			THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE

International Family Members for US Patent 8,475,832

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	078417
Australia	2010279440
Brazil	112012002817
Canada	2770180
Chile	2012000313
China	102548535