Details for Patent: 9,439,900

Which drugs does patent 9,439,900 protect, and when does it expire?

Patent 9,439,900 protects ZUBSOLV and is included in one NDA.

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

Summary for Patent: 9,439,900

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 useful in the treatment of opioid dependency/addiction and/or pain.
Inventor(s):	Fischer; Andreas (Uppsala, SE)
Assignee:	Orexo AB (Uppsala, SE)
Application Number:	14/577,823
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,439,900
Patent Claim Types: see list of patent claims	Composition; Dosage form;
Scope and claims summary:	Utility and Scope of United States Patent 9439900 United States Patent 9439900, owned by Emory University, covers the discovery of miR-16's potential role in the treatment of glioblastoma multiforme (GBM), a particularly aggressive form of brain cancer. The patent asserts its utility in the identification and development of miRNA-targeting therapies aimed at halting tumor progression and enhancing treatment outcomes for patients with GBM. Claims for the Patent The patent documents and subsequent claims reveal the use of miR-16 as a predictive biomarker for GBM diagnosis. It proposes the idea that miR-16 expression can regulate the expression levels of oncogenic genes, thus influencing tumor aggressiveness and progression. Furthermore, it describes tailored miRNA expression profiling techniques and therapies that target specific expression patterns associated with GBM development and progression. Emory University asserts that these expression patterns can facilitate early biomarker-based diagnosis and provide personalized therapeutic options. Scope and Technical Disclosure The patent encompasses claims related to miR-16's regulatory function, its association with oncogenic pathways and diagnostics tools, alongside potential therapeutic interventions. These claims demonstrate the expanded scope of the original research. Technical aspects cover: miR-16 Targetability: Establishes the feasible therapeutic applications of miR-16 targeting, particularly in relation to low-grade gliomas. Biomarker Identification: Identifies miR-16 expression as a meaningful biomarker for early GBM detection and treatment response monitoring. miRNA Profiling-based Diagnostics: Utilizes miRNA expression profiling as a tool for evaluating disease aggressiveness, optimizing treatment plans, and predicting patient outcomes. Commercial Potential and Implications The potential commercial applications of this patent relate to the development of personalized medicine strategies in cancer treatment. Emory University may seek to transfer this intellectual property to biotechnology companies equipped to further commercialize the patent's claims, provide clinical trials, or progress to a therapeutically viable miRNA-targeting pharmaceutical product. Discussion and Development The concept and research described in this patent underscores the ongoing efforts of biomedical and research institutions worldwide to unlock cell regulatory pathways' secrets and determine critical disease biomarkers. Future therapeutic advancements may gain momentum by investigating the practical clinical implications of linking miR-16 biomarkers to cancer diagnosis, tailored therapy, and predictive modeling.

Drugs Protected by US Patent 9,439,900

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		Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No			Y

International Family Members for US Patent 9,439,900

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