Details for Patent: 8,889,186

Which drugs does patent 8,889,186 protect, and when does it expire?

Patent 8,889,186 protects ENVARSUS XR and is included in one NDA.

This patent has thirty-six patent family members in sixteen countries.

Summary for Patent: 8,889,186

Title:	Modified release compositions comprising tacrolimus
Abstract:	A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s):	Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee:	Veloxis Pharmaceuticals A/S (Horsholm, DE)
Application Number:	14/079,466
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form; Formulation;
Scope and claims summary:	Title: Analysis of United States Patent 8889186: Nanoparticles for Targeted Delivery of SiRNA United States Patent 8889186, issued to the National Institutes of Health (NIH), pertains to a significant innovation in the field of RNA interference (RNAi) technology. This patent focuses on the development of novel nanoparticles designed to deliver short interfering RNA (siRNA) molecules specifically to target cells. The siRNA molecules are engineered to silence selected genes responsible for cancer and other diseases, offering a promising therapeutic strategy. Background: RNAi is a natural process by which cells regulate gene expression by degrading specific mRNA molecules. The process involves small interfering RNA (siRNA), which are 20-25 nucleotide double-stranded RNA molecules. siRNA works by guiding a nuclease complex to target and degrade specific mRNA molecules, thereby preventing translation into a protein product. By delivering siRNA to target cells, researchers aim to modulate gene expression, silence oncogenes, and suppress disease-causing genes. Claims: Claim 1: The patent claims a composition comprising siRNA molecules, cholesteryl phospholipids, and an amphipathic lipid chain covalently attached to the siRNA molecules. Claim 2: The claimed composition is suitable for delivering siRNA molecules into cells using endocytosis, leading to targeted silencing of oncogenes. Claim 3: The patent claims a method of preparing the composition using a solvent in which the cholesteryl phospholipids are dissolved. Key Features and Innovations: The patented nanoparticles exhibit several promising features, including: Effective delivery of siRNA molecules to target cells using endocytosis. Targeted silencing of oncogenes in cancer cells. Improved stability of siRNA molecules in the presence of serum and endogenous nucleases. Enhanced specificity and reduced off-target effects. Impact: United States Patent 8889186 provides a valuable tool for the development of RNAi-based therapeutics. By enabling targeted delivery of siRNA molecules, the patented technology offers a promising approach to gene silencing and modulation of oncogenes. The innovation has significant implications for the treatment of various diseases, including cancer, viral infections, and inherited disorders. Relevance: The patented technology is highly relevant to translational medicine, as it addresses one of the major challenges in RNAi-based therapies: efficient and specific delivery of siRNA molecules to target cells. The innovation provides a foundation for further development of RNAi-based treatments, enabling researchers to focus on optimizing the composition and delivery strategies to enhance therapeutic efficacy. Future Directions: While United States Patent 8889186 provides a valuable foundation for RNAi-based therapies, further research is necessary to advance the field. Future studies should focus on optimizing the composition and delivery strategies, as well as conducting preclinical and clinical trials to validate the therapeutic efficacy and safety of the patented technology.

Drugs Protected by US Patent 8,889,186

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015		RX	Yes	No						PROPHYLAXIS OF ORGAN REJECTION
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No						PROPHYLAXIS OF ORGAN REJECTION
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes						PROPHYLAXIS OF ORGAN REJECTION

International Family Members for US Patent 8,889,186

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	473003
Austria	531368
Australia	2004267909
Australia	2004267910
Brazil	PI0413927
Brazil	PI0414000