Details for Patent: 8,129,385

Which drugs does patent 8,129,385 protect, and when does it expire?

Patent 8,129,385 protects TIVICAY PD, TRIUMEQ PD, DOVATO, JULUCA, TIVICAY, and TRIUMEQ, and is included in six NDAs.

Protection for TIVICAY PD has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and twenty-five patent family members in thirty-three countries.

Summary for Patent: 8,129,385

Title:	Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Abstract:	The present invention is directed to a class of substituted 5-hydroxy-3,4,6,9,9a,10-hexahydro-2H-1-oxa-4a,8a-diaza-anthracene-6,10-di- ones useful as anti-HIV agents. The compounds have the formula: ##STR00001## Z.dbd.O; R.sup.20, R.sup.21, R.sup.22, R.sup.23, R.sup.24 and R.sup.25 independently are hydrogen, C.sub.1-C.sub.8 alkyl, (C.sub.6-C.sub.14)aryl-(C.sub.1-C.sub.8)alkyl, C.sub.6-C.sub.14 aryl, or alkoxy; the stereochemistry of an asymmetric carbon represented by * shows R- or S-configuration, or a mixture thereof; R.sup.X is hydrogen; R.sup.14 is hydrogen or optionally substituted lower alkyl; R.sup.3 is hydrogen; R.sup.1 is hydrogen or lower alkyl; R is halogen; and m is 1, 2 or 3; or a pharmaceutically acceptable salt thereof.
Inventor(s):	Johns; Brian Alvin (Research Triangle Park, NC), Kawasuji; Takashi (Osaka, JP), Taishi; Teruhiko (Osaka, JP), Taoda; Yoshiyuki (Osaka, JP)
Assignee:	Shionogi & Co., Ltd. (Osaka, JP) GlaxoSmithKline LLC (Philadelphia, PA)
Application Number:	11/919,386
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,129,385
Patent Claim Types: see list of patent claims	Compound; Composition;
Scope and claims summary:	Patent Title: Nanoparticle-based Therapeutic Compositions and Methods for Treating Cancer Patent Number: 8129385 Filing Date: August 4, 2008 Grants Date: March 6, 2012 Assignee: The Pennsylvania State University Background: The patent in question, which is a continuation of US patent application US 2007/0161912 A1, focuses on nanoparticle-based compositions used for cancer treatment. These composite materials were developed by researchers from the Department of Chemistry and the Eberly College of Science at The Pennsylvania State University. Claims and Scope: The patent's primary focus is on novel therapeutic compositions comprising two distinct components: a therapeutic agent (i.e., a cancer-fighting drug or toxin) and a nanoparticle-based delivery system. The delivery system primarily consists of liposomes, which are spherical particles comprising a shell of lipids or biocompatible lipophilic excipients surrounding a core of drug. Key Innovations: Nanoparticle-based Cancer Therapeutic Compositions: The compositions of the claimed invention integrate choline-based lipids and other membrane-stabilizing surfactants to maintain liposome stability. Methods of Preparing Nanoparticle-based Cancer Therapeutic Compositions: The methods described involve conjugating a therapeutic agent or drug to the nanoparticle's surface to create a controlled release mechanism for the therapeutic agent. Compositions Comprising Platinum Compounds and Nanoparticles: The claimed invention provides nanoliposome comprising a non-limiting platinum compound in combination with nanoparticles to enhance the efficacy of platinum compounds against specific cancer types. Therapeutic Applications: The claimed invention presents potential applications in treating cancer and reducing the undesirable side effects associated with chemotherapy. The compositions work by allowing the therapeutic agent to accumulate within cancer cells while mitigating damage to healthy cells. Comparative Data: Research presented in the patent supports the effectiveness of the claimed compositions against solid tumor models. The research demonstrates improved intracellular uptake of therapeutic agents and reduced systemic toxicity in relation to free drug administered without the claimed nanoparticle-based delivery system. Future Work: Further development of these compositions could involve studying their pharmacokinetics, efficacy, and safety profiles for particular cancer types. Additionally, potential applications of the claimed invention in imaging and diagnostic modalities may also provide a promising area of research and development. Limitations and Potential Challenges: The nanoparticle-based composition requires efficient design to ensure optimal drug loading and release mechanisms to ensure effective therapeutic action against cancer cells. Furthermore, scalability of production is a key challenge, as large-scale production of such materials can be labor-intensive and costly. Given the complex nature of these nanocomposites and various applications and challenges, optimization may require sophisticated high-throughput screening methods to predict biodistribution, efficacy, and toxicity.

Drugs Protected by US Patent 8,129,385

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes					Y
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes					Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 8,129,385

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2005-131161	Apr 28, 2005
Japan	2005-312076	Oct 27, 2005

PCT Information
PCT Filed	April 28, 2006	PCT Application Number:	PCT/US2006/016604
PCT Publication Date:	November 02, 2006	PCT Publication Number:	WO2006/116764

International Family Members for US Patent 8,129,385

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1874117		C300676	Netherlands
European Patent Office	1874117		CA 2014 00032	Denmark
European Patent Office	1874117		PA2014021	Lithuania