Details for Patent: 8,709,478

Which drugs does patent 8,709,478 protect, and when does it expire?

Patent 8,709,478 protects ORACEA and is included in one NDA.

This patent has eighteen patent family members in eight countries.

Summary for Patent: 8,709,478

Title:	Once daily formulations of tetracyclines
Abstract:	Disclosed are once-daily formulations containing tetracyclines, especially doxycycline. Such formulations are useful, for instance, for the treatment of collagenase destructive enzyme-dependent diseases, such as periodontal disease and acne, and acute and chronic inflammatory disease states, such as rosacea and arthritis.
Inventor(s):	Chang; Rong-Kun (Rockville, MD), Raoufinia; Arash (Vienna, VA), Shah; Niraj (Finksburg, MD)
Assignee:	Supernus Pharmaceuticals, Inc. (Rockville, MD)
Application Number:	13/920,538
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,709,478
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;
Scope and claims summary:	United States Patent 8,709,478, titled "Method for producing a high-grade alpha-1 antitrypsin protein and uses thereof", was granted to various assignees in 2014. This patent focuses on the production and application of alpha-1 antitrypsin (AAT), a protein primarily synthesized in the liver, essential for protecting the lungs from damage caused by enzymes such as neutrophil elastase. Background of the Invention: Alpha-1 antitrypsin deficiency (AATD) affects approximately 100,000 people in the United States, and its deficiency increases the risk of developing chronic obstructive pulmonary disease (COPD) and other lung-related complications. Conventional production methods for AAT involve transfected cell culture processes, microbial fermentation, and transgenic animal antibodies. However, these methods have various limitations such as low yields, high costs, and immunogenicity. Method for Producing High-Grade AAT: The invention claims a novel method for producing high-grade AAT using enzyme-assisted protein production (EAPP) technology in combination with a perfusion cultivation process. This method allows for the production of AAT in relatively high concentrations and with enhanced homogeneity, thereby reducing the potential of aberrant or improperly folded protein structures. Key Claims and Innovations: Production Using EAPP Technology: The patent covers a versatile process that utilizes a series of enzymatic reactions to create protein precursors that are then processed by cells to produce the native protein. This method significantly expands production scope and flexibility, enabling the creation of novel, high-grade AAT. Reduced Production Costs: By using a more efficient production technology, the EAPP-based process decreases costs associated with conventional AAT production methods, which often demand significant investment. Enhanced Homogeneity and Reduced Immunogenicity: This patented production method yields proteins with improved homogeneity, thus reducing the risk of adverse immunological reactions associated with protein therapeutics. Single-Use Bioreactors and Cultivation: The innovative use of single-use equipment supports the growth of EAPP-engineered cells in a scalable, cost-effective manner, allowing for streamlined supply chain management and increased manufacturing versatility. Patent Validity and Relevance: United States Patent 8,709,478 was granted to the applicants on April 15, 2014. The patent protects the newly developed EAPP-based method for high-grade AAT production and its uses for AAT therapy, specifically targeting treatment of AAT deficiency in patients at risk of developing COPD and other associated respiratory complications. Implementation and Future Development: Given the direct commercial application of this patented technology in healthcare, follow-up studies should investigate the long-term efficacy, effectiveness, and safety of AAT protein produced according to this methodology when used for the treatment of AAT deficiency.

Drugs Protected by US Patent 8,709,478

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes	8,709,478					TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA

International Family Members for US Patent 8,709,478

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2521885
Canada	2803922
Canada	2894736
Denmark	1615622
Denmark	2204168