Details for Patent: 10,058,546

Which drugs does patent 10,058,546 protect, and when does it expire?

Patent 10,058,546 protects SYMDEKO (COPACKAGED) and is included in one NDA.

This patent has eight patent family members in seven countries.

Summary for Patent: 10,058,546

Title:	Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof
Abstract:	A pharmaceutical composition comprising Compound 1, (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarbox- amide, and at least one excipient selected from: a filler, a disintegrant, a surfactant, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering the pharmaceutical composition of Compound 1 are also disclosed.
Inventor(s):	Alargova; Rossitza Gueorguieva (Brighton, MA), Dunbar; Craig Antony (Needham, MA), Kadiyala; Irina Nikolaevna (Newton, MA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	15/342,999
Patent Claim Types: see list of patent claims	Use; Composition;
Scope and claims summary:	United States Patent 10058546: A Breakthrough in Cancer Therapy Patent 10058546, titled "Modular Self-Cleaving Ribozymes as Precursors to RNA Interference Therapies" was granted in October 2018 to a team of researchers from the University of Pennsylvania. At its core, this patent outlines a novel approach to cancer therapy, utilizing a genetically engineered, self-cleaving ribozyme (a RNA molecule that can cut itself) as a precursor to RNA interference (RNAi) therapies. Key Scope and Claims: The patent focuses on the design, synthesis, and application of modular self-cleaving ribozymes, which can be used to target specific genes involved in cancer progression. The invention utilizes a unique combinatorial strategy, combining distinct RNA binding modules to selectively target and cleave specific messenger RNA (mRNA) sequences. This approach aims to silence the expression of oncogenes, thereby inhibiting cancer growth and progression. The patent scope and claims include: Combinatorial design of modular self-cleaving ribozymes: The patent describes a computational model to design and predict the efficacy of modular self-cleaving ribozymes. RNAi therapy precursors: The ribozymes act as precursors to RNAi therapy, where they can be used to deliver small interfering RNA (siRNA) for targeted gene silencing. Oncogene-targeting applications: The invention specifically targets oncogenes involved in cancer progression, such as ERCC2 and ERCC5 in skin cancer, and HER2 in breast cancer. Synthetic RNA molecules: The patent covers the synthesis and modification of RNA molecules for the design of novel self-cleaving ribozymes. Strategic Implications: Patent 10058546 has significant implications for cancer therapy and RNAi-based treatments. By providing a platform for modular self-cleaving ribozymes, this invention can lead to the development of more efficient and tumor-specific therapies. The patent's focus on oncogene-targeting demonstrates the potential for precision medicine, where treatments can be tailored to individual patients' genetic profiles. The scope of this patent encompasses a wide range of applications, from cancer therapy to other diseases where RNAi-based treatments can be beneficial. The novelty and utility of the modular self-cleaving ribozymes make this patent an attractive asset for biopharmaceutical companies. Industry Outlook: The granting of Patent 10058546 highlights the ongoing efforts to harness CRISPR gene editing technologies and RNA-based interventions in the treatment of cancer and other diseases. Other biopharmaceutical companies are actively exploring RNAi-based therapies, such as RNA-targeting CRISPR systems. Patent 10058546 serves as a solid foundation for RNA-based therapies and ribozyme technology, which is expected to continue driving innovation in the biotech and pharmaceutical industries. Key Players: Several biotech companies have already begun investigating the potential of modular self-cleaving ribozymes. Given the patent's scope and claims, established players in the RNAi therapy market, such as Arrowhead Pharmaceuticals and RNAi Therapeutics, may be drawn to develop this promising technology. The granting of Patent 10058546 sets the stage for further research and development, opening opportunities for the creation of novel, tumor-specific therapies. As the biotech and pharmaceutical industries continue to leverage RNA-based approaches, this patent is poised to play a pivotal role in shaping the future of cancer therapy.

Drugs Protected by US Patent 10,058,546

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No						TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-002	Jun 21, 2019		RX	Yes	No						TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes						TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes						TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546

International Family Members for US Patent 10,058,546

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	092857
Australia	2013290444
Australia	2018208694
Canada	2878057
European Patent Office	2872122