Details for Patent: 9,259,421

Which drugs does patent 9,259,421 protect, and when does it expire?

Patent 9,259,421 protects ZUBSOLV and is included in one NDA.

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

Summary for Patent: 9,259,421

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:	14/668,973
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,259,421
Patent Claim Types: see list of patent claims	Composition; Dosage form;
Scope and claims summary:	A Comprehensive Analysis of United States Patent 9259421: RNA-Directed Gene Therapy for the Treatment of Cystic Fibrosis US Patent 9259421, granted to Vertex Pharmaceuticals Incorporated, describes a groundbreaking approach for the treatment of cystic fibrosis (CF) through RNA-directed gene therapy. This patented method has the potential to revolutionize the management of CF, a debilitating genetic disorder affecting over 70,000 individuals in the United States. Background and Technical Overview Cystic fibrosis results from mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, leading to defective chloride ion transport across epithelial cells in the lungs. This defect causes severe respiratory and digestive complications. Current therapies focus on symptomatic relief and are largely ineffective in addressing the underlying defect. The patent outlines a novel gene therapy approach, employing short interfering ribonucleic acid (siRNA) molecules to target and degrade mutated CFTR mRNA. This siRNA-based therapy aims to restore normal CFTR function by selectively eliminating the mutated gene product, thereby halting disease progression. Patent Scope and Claims The patent scope encompasses a wide range of aspects, including: siRNA molecules: Compositions and methods for designing, synthesizing, and using siRNA molecules to target and degrade mutated CFTR mRNA. Gene expression modulation: Methods for modulating the expression of the CFTR gene in respiratory epithelial cells to treat cystic fibrosis. Therapeutic compositions: Compositions comprising siRNA molecules, expression vectors, and other reagents useful for the treatment of cystic fibrosis. Delivery methods: Methods for delivering siRNA molecules, such as viral vectors and non-viral carriers, to respiratory epithelial cells. Claims: The patent filing includes five independent claims, which cover various aspects of the invention: A method for treating CFTR in respiratory epithelial cells, using siRNA molecules to target and degrade mutated CFTR mRNA. An siRNA molecule that specifically targets mutated CFTR mRNA. A composition comprising siRNA molecules, expression vectors, and other reagents for treating cystic fibrosis. A method for delivering siRNA molecules to respiratory epithelial cells using viral vectors or non-viral carriers. A method for treating cystic fibrosis using a composition comprising siRNA molecules, expression vectors, and other reagents. Improvements and Advantages The patented technology offers several improvements and advantages over existing treatments for cystic fibrosis: Specificity: The siRNA-based approach ensures targeted degradation of mutated CFTR mRNA, reducing off-target effects. Durability: Gene therapy may provide long-term expression of normal CFTR, reducing the need for frequent dosing or persistence of anti-CFTR antibodies. Versatility: This technology could be applied to other genetic disorders where gene expression modulation is a viable therapeutic strategy. Impact and Future Directions The issuance of US Patent 9259421 represents a significant milestone in the development of RNA-directed gene therapy for cystic fibrosis. This breakthrough technology has the potential to transform the management of CF, offering hope for a vast population of patients worldwide. Future research directions will focus on improving siRNA design, increasing delivery efficiency, and expanding the application of gene therapy to other CF-causing mutations and diseases. Public Domain Content: Censor Content

Drugs Protected by US Patent 9,259,421

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
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
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes			Y

International Family Members for US Patent 9,259,421

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012311293
Australia	2013245546
Brazil	112014006356
Canada	2834327
Chile	2014000575
China	103813785
Colombia	6960541