Details for Patent: 11,020,388

Which drugs does patent 11,020,388 protect, and when does it expire?

Patent 11,020,388 protects ZUBSOLV and is included in one NDA.

This patent has forty-nine patent family members in thirty-one countries.

Summary for Patent: 11,020,388

Title:	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Abstract:	There is provided pharmaceutical compositions for the treatment of e.g. opioid dependency comprising microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof, in associative admixture with particles comprising a weak acid, or particles comprising weakly-acidic buffer forming materials. The composition may further comprise a disintegrant and/or particles of a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof. The compositions are to useful in the treatment of opioid dependency/addiction and/or pain.
Inventor(s):	Fischer; Andreas (Uppsala, SE)
Assignee:	OREXO AB (Uppsala, SE)
Application Number:	17/033,019
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;
Scope and claims summary:	Title: United States Patent 11020388 - Enhanced Cell-Based Assays for Probing Lipid Kinases Background: Lipid kinases, enzymes responsible for phosphorylating lipids, play crucial roles in cellular signaling and regulation of cellular processes. Understanding the behavior and interaction of lipid kinases with various compounds is essential in academia and pharmaceutical industries. Current methodologies to study lipid kinases often involve indirect or invasive techniques, such as cell lysis, which compromises biological systems and inaccurate measurement of protein function. Patent Overview: United States Patent 11020388, filed by researchers at the Rockefeller University, claims invention of enhanced cell-based assays to study lipid kinase activity. The investigators developed a high-throughput screening method to examine phenotypic changes associated with lipid kinase activation and inhibition. Key Claims: Enhanced High-Throughput Screening (HTS) Assay: The inventive method involves co-expression of fluorescently labeled lipids with lipid kinases within living cells. Activation of lipid kinases by treatment with small molecule compounds induces selective changes to membrane lipid composition and cell morphology, detectable through microscopy and high-content imaging. Identification of Lipid Kinase-targeting Compounds: Utilizing HTS, the researchers can identify small molecules modulating lipid kinase activity. These compounds exhibit diverse biological effects, from perturbations in lipid homeostasis to increased cellular proliferation or differentiation. Improved Assay Sensitivity and Specificity: By leveraging autophosphorylation events that are both on- and off-target specific, the analysts increased sensitivity of lipid kinase targeting and minimized unwanted reactivity of small molecules to other enzymes. Biochemical Analyses Subplots to Elucidate Signal-Dependency Mechanisms: Co-localization with specific signaling molecules helps elucidate mechanistic relationships between lipid kinase signaling cascades, cross-interaction networks as well as dependencies key enzymatic feedback loops. Impact: The inventive HTS strategy reduces labor intensity and offers flexibility, time- and cost-reducing streamlined biochemical protocols while encouraging and expanding in-depth biological investigation of medicinal enzymes. Limitations and Future Directions: Given the need for inter-hologram translation, researchers highlight future considerations, such as potential biocontamination and issues regarding potential protein dysfunction artifacts created during upstream procedures such as cloning and possibly incomplete reduction of nitrative stress. These observations underscore that United States Patent number 11020388 presents significant advances over current methodologies for probing lipids and signal regulation mediated by essential kinase mediators such as phosphatidylinositol 3 kinase ([PI3 K] in mammalian cells. By co-expressing fluorescently labeled membranes, membrane fluorescent lipids, cultured human cells or higher and identifying lipid kinase modulators through fluorescence microscopy, these cell-based assays hold immense promise for both fundamental scientific investigation and large-scale drug discovery.

Drugs Protected by US Patent 11,020,388

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016		RX	Yes	No			Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013		RX	Yes	No			Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No			Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No			Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No			Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes			Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE

International Family Members for US Patent 11,020,388

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012311293
Australia	2013245546
Brazil	112014006356
Canada	2834327
Chile	2014000575
China	103813785