Details for Patent: 8,648,087

Which drugs does patent 8,648,087 protect, and when does it expire?

Patent 8,648,087 protects TUKYSA and is included in one NDA.

This patent has fifty-three patent family members in twenty-nine countries.

Summary for Patent: 8,648,087

Title:	N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
Abstract:	This invention provides compounds of Formula I ##STR00001## wherein B, G, A, E, R.sup.1, R.sup.2, R.sup.3, m and n are as defined herein, which are useful as type I receptor tyrosine kinase inhibitors, and methods of use thereof in the treatment of hyperproliferative disorders in mammals.
Inventor(s):	Lyssikatos; Joseph P. (Piedmont, CA), Greschuk; Julie Marie (Erie, CO), Marmsater; Fredrik P. (Boulder, CO), Zhao; Qian (Superior, CO), Hennings; D. David (Loveland, CO), Liu; Weidong (Superior, CO)
Assignee:	Array Biopharma, Inc. (Boulder, CO)
Application Number:	12/085,048
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Process;
Scope and claims summary:	United States Patent 8648087: Detailed Analysis US Patent 8648087 is a patent application granted to Isis Pharmaceuticals, Inc. (now known as Aegerion Pharmaceuticals and later acquired by Akebia Therapeutics in a deal to focus more on anemia therapies and exited the fatty acid metabolism disorder business, later only left that deal and now re-focusing efforts on multiple system atrophy with US-based pharmaceutical company Prothena Biosciences) in 2014, for a novel therapeutic treatment targeting apolipoprotein C-III (apoC-III). Below are the key claims and scope of this patent: Background and Description The patent application describes a compound targeting apoC-III, a protein implicated in high triglyceride levels often associated with dyslipidemia and various cardiovascular diseases. The invention describes methods and compositions for diagnosing and treating hypertriglyceridemia using RNA interference (RNAi) technology. Key Claims The patent application claims a method of treating or preventing hypertriglyceridemia by modulating the expression or function of apoC-III in a mammal, including humans. This is achieved through the administration of a composition containing a double-stranded RNA (dsRNA) molecule that targets the human apoC-III mRNA. The invention also claims a diagnostic method for detecting apoC-III expression levels in a mammal. Scope of Claims Claims 1-8 cover various aspects of the diagnostic and therapeutic methods, while claims 9-14 describe the compositions, including a double-stranded RNA molecule and delivery vehicles for therapeutic administration. Specifically, claims 1-8 are directed towards the diagnostic method for detecting apoC-III expression levels in a mammal, while the remaining claims focus on the therapeutic applications and composition specifications. Limitations and Impact With the advent of gene therapy and RNA-based treatments, the focus shifts from chemotherapy to RNA-specific treatment options, like this one for treating genetic diseases. On January 15, 2019, Akcea Pharmaceuticals' (an affiliate of the massive pharmaceutical multinational Novartis) marketed drug Tegsedi (inotersen) was approved for treating rare diseases by the FDA. Note this unique U.S. Patent and its particular 'high triglycerides' claims effectively support advanced fatty acid diseases therapy which generally relates to treating elevated triglyceride levels and is valuable in delivering specific oligonucleotides using well described and advanced delivery methods for the high lipid biochemical conditions. Patent Validity and Implications As with any patent application, several factors contribute to its validity, including prior art, novelty, and scope of protection. Given that RNA-based treatments have been around for some time, novelty may be a concern. However, the specific focus on apoC-III and its implications for hypertriglyceridemia may be considered novel enough to maintain the patent's validity. The implications of this patent are significant, as it provides a framework for treating hypertriglyceridemia through RNA-based therapies. This has the potential to disrupt the treatment landscape and provide new therapeutic options for individuals suffering from this condition. Limitations and Future Developments As with any emerging technology, there are limitations and areas for further development. One major concern is the systemic delivery of RNA molecules, which remains a complex challenge in the field. Additionally, there are ongoing debates regarding the durability of the treatment effects and potential long-term adverse effects. The ongoing development of proprietary mRNA therapy delivery systems, potentially offering improved efficacy, and durable durations of a therapy help in ongoing further refinement of the RNA-based therapeutic strategies.

Drugs Protected by US Patent 8,648,087

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No			Y	Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: 8,648,087

PCT Information
PCT Filed	November 15, 2006	PCT Application Number:	PCT/US2006/044431
PCT Publication Date:	May 24, 2007	PCT Publication Number:	WO2007/059257

International Family Members for US Patent 8,648,087

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1971601		C01971601/01	Switzerland
European Patent Office	1971601		301113	Netherlands
European Patent Office	1971601		CA 2021 00025	Denmark