Last Updated: November 9, 2026

Details for Patent: 12,257,342

Name: Drug Patent Intelligence for US Patent 12257342
Creator: DrugPatentWatch
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Which drugs does patent 12,257,342 protect, and when does it expire?

Patent 12,257,342 protects IMMPHENTIV and is included in one NDA.

Summary for Patent: 12,257,342

Title:	Phenylephrine hydrochloride ready-to-use solution
Abstract:	This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.
Inventor(s):	David E. McAnany, Michael G. Parker, Sarah D. McCue
Assignee:	Hikma Pharmaceuticals USA Inc
Application Number:	US17/941,640
Patent Claim Types: see list of patent claims	Use; Formulation;

Drugs Protected by US Patent 12,257,342

Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Hikma	IMMPHENTIV	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	203826-004	Mar 9, 2023		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
Hikma	IMMPHENTIV	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	203826-005	Mar 9, 2023		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

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