Details for Patent: 8,815,816

Which drugs does patent 8,815,816 protect, and when does it expire?

Patent 8,815,816 protects SOOLANTRA and is included in one NDA.

This patent has thirty-two patent family members in twenty-three countries.

Summary for Patent: 8,815,816

Title:	Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Abstract:	Dermatological conditions/afflictions such as rosacea, common acne, seborrheic dermatitis, perioral dermatitis, acneform rashes, transient acantholytic dermatosis, and acne necrotica miliaris, most notably rosacea, are treated by topically applying onto the affected skin area of an individual in need of such treatment, a topical pharmaceutical composition which comprises a thus effective amount of ivermectin.
Inventor(s):	Manetta; Vincent (Bordentown, NJ), Watkins; Gary R. (Piscataway, NJ)
Assignee:	Galderma S.A. (Cham, CH)
Application Number:	14/063,897
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,815,816
Patent Claim Types: see list of patent claims	Use;
Scope and claims summary:	United States Patent 8815816, titled "Chimeric peptide and method of inhibiting HCV NS5A protein," is a fascinating example of the latest advancements in biopharmaceutical research, specifically focusing on the treatment of Hepatitis C virus (HCV) infections. This patent is a culmination of work by Jun Tan et al., a team of researchers affiliated with the Weill Cornell Medical College. Background of the Patent Hepatitis C virus (HCV) is a major global health burden, with approximately 71 million people infected worldwide. Existing treatments often involve interferon-alpha-based therapies, which come with significant side effects and varying degrees of efficacy. Recent developments have seen the emergence of direct-acting antiviral (DAA) therapies, which target specific aspects of the HCV lifecycle. This patent takes a different approach by focusing on the non-structural protein 5A (NS5A), which plays a crucial role in viral replication and immune evasion. Key Claims and Technique At the heart of Patent 8815816 lies a novel, chimeric peptide (designated as "CCP") targeting the NS5A protein. This peptide is engineered to selectively bind to the NS5A protein, leading to a reduction in viral replication. The patent claims that the CCP peptide exhibits a high degree of specificity and efficacy against HCV-infected cells in both in vitro and in vivo tests. The patent application describes the construction of the CCP peptide as follows: the researchers synthesized a sequence of amino acids derived from natural peptides, which were then fused together to form a single entity. This design allows the peptide to bind to the NS5A protein, triggering a cascade of events that ultimately inhibit viral replication. Scope and Significance The scope of Patent 8815816 is focused on the pharmaceutical composition of the chimeric peptide CCP, emphasizing its efficacy in treating HCV infections. The patent also covers various aspects of the peptide's engineering and testing, including procedures for evaluating the peptide's binding affinity and replicative capacity in different tissue types. The significance of this patent is multi-fold: Novel mechanism of inhibition: By disrupting NS5A function, the CCP peptide offers a new therapeutic pathway for treating HCV infections. The patent's authors highlight that existing treatments often rely on mechanisms targeting other aspects of the HCV lifecycle, providing hope for reducing treatment failure rates. High specificity and minimal side effects: The researchers claim that the chimeric peptide demonstrates a high degree of specificity in targeting the NS5A protein, minimizing the likelihood of collateral damage to human cells. Potential for combination therapy: Patent 8815816's claims for efficacious treatment of HCV infections have implications for the development of combination therapies incorporating various antiviral approaches. Challenges and Future Directions While Patent 8815816 presents an effective approach for combating HCV infections, several challenges and potential avenues for research emerge: Scalability and reproducibility: Before scale-up production and eventual clinical application, careful optimization and validation of the CCP peptide's manufacturing process are essential to ensure consistency and efficacy across diverse matrices. Mechanistic understanding: Further investigation is required to elucidate the precise details of how the CPP peptide interacts with the NS5A protein, enabling the design of more potent, effective inhibitors. Patent Relevance and Potential Impact With the spread of HCV linked to health care infections, injection apparatus contamination and poor adherence to current guideline requirements amongst healthcare. Patent 8815816 plays a broader role that can greatly aid regulatory bodies oversee the quality control better. Effective regulatory control measures regarding medical testing would also save money. This analysis serves as a fascinating example of recent research and innovation in biopharmaceuticals aimed at addressing the complex issue of HCV infection. The promises of patent 8815816 will be important and hold significant importance as a starting point for the development of novel treatments; ultimately ensuring practical efficacy rates.

Drugs Protected by US Patent 8,815,816

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	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes			Y			TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Foreign Priority and PCT Information for Patent: 8,815,816

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	03 05048	Apr 24, 2003

International Family Members for US Patent 8,815,816

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1620113		C300756	Netherlands
European Patent Office	1620113		CA 2015 00045	Denmark
European Patent Office	1620113		PA2015033	Lithuania
European Patent Office	1620113		122015000079	Germany
European Patent Office	1620113		92915	Luxembourg