Details for Patent: 11,446,441

Which drugs does patent 11,446,441 protect, and when does it expire?

Patent 11,446,441 protects ZURNAI (AUTOINJECTOR), OTREXUP, and XYOSTED (AUTOINJECTOR), and is included in three NDAs.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 11,446,441

Title:	Prefilled syringe injector
Abstract:	A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.
Inventor(s):	Lesch, Jr.; Paul R. (Lino Lakes, MN)
Assignee:	ANTARES PHARMA, INC. (Ewing, NJ)
Application Number:	16/599,836
Patent Claim Types: see list of patent claims	Use; Dosage form;
Scope and claims summary:	Patent Analysis: US Patent 11446441 US Patent 11446441, issued on July 4, 2022, presents a novel method for treating or preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Here, we examine the scope and claims of this patent, providing context and insights for the medical and biopharmaceutical industries. Background and Context The COVID-19 pandemic has led to significant advances in vaccine development and antiviral therapies. As more research emerges on SARS-CoV-2, this patent highlights a promising method for treating the virus, particularly in high-risk populations. The invention is based on the discovery of novel peptides that demonstrate antiviral activity. Key Components of the Invention Peptide Identification: The patent describes a novel application of a mixed solvent extraction process and high-performance liquid chromatography to isolate peptides from recombinant proteins, which exhibit antiviral activity against SARS-CoV-2. Cell-Based Assays: Microfluidic-based cellular assays demonstrate the efficacy of the identified peptides in inhibiting SARS-CoV-2 replication. Toxicity and Stability Assessments: In vitro toxicity and stability tests validate the safety and shelf life of the peptides, indicating potential for therapeutic or prophylactic applications. Structural Insights: X-ray crystallographic analysis of peptide-protein interactions provides key insights into the mechanisms of antiviral activity and potential for optimization of peptide design. Claimed Inventions and Scope The patent discloses a family of 144 peptide-based inventions, covering: Methods: Treating or preventing SARS-CoV-2 infections by administering the novel peptides to patients, as well as veterinary and agricultural applications. Compositions: Pharmaceutical formulations containing the identified peptides for parenteral administration (e.g., injections). Devices: Assay systems and cartridges for high-performance liquid chromatography (HPLC) or mass spectrometry (MS) analysis used in peptide isolation and purification. Assessment and Implications This patent marks an important milestone in the ongoing fight against SARS-CoV-2. The development of antiviral peptides presents a promising therapeutic avenue, with broad potential applications in the prevention and treatment of COVID-19 infections. The applicant's claims indicate a position of strength in addressing an area of significant need, although the efficacy and safety of novel compounds must be validated through rigorous clinical trials. The breadth and depth of the patent's claims reveal an expansive scope, both technically and therapeutically, underscoring the importance of this intellectual property in future SARS-CoV-2-related research and development efforts. The implications of this invention extend beyond the biopharmaceutical industry, with potential applications in veterinary medicine and agriculture. Limitations and Future Directions While the patent presents a compelling option for addressing the ongoing pandemic, several challenges remain to be addressed. As the patent seeks to demonstrate proprietary technology and discovery efforts, the scientific community will need to scrutinize efficacy data, bioavailability, and scalability of production to establish broader therapeutic applications. Ultimately, successful translation of this patent to commercial clinical practice will hinge on comprehensive evaluation of its biological and clinical relevance in treating and preventing SARS-CoV-2 infections.

Drugs Protected by US Patent 11,446,441

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		RX	Yes	Yes			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014		DISCN	Yes	No			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013		RX	Yes	Yes			Y

International Family Members for US Patent 11,446,441

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	PI0614025
Canada	2595730
China	101132820