Last Updated: September 24, 2026

STERILE WATER FOR INJECTION Drug Patent Profile


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Which patents cover Sterile Water For Injection, and when can generic versions of Sterile Water For Injection launch?

Sterile Water For Injection is a drug marketed by Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Medefil Inc, Nephron, Nexus, B Braun, Baxter Hlthcare, Otsuka Icu Medcl, and Taro. and is included in fifteen NDAs.

The generic ingredient in STERILE WATER FOR INJECTION is sterile water for injection. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sterile Water For Injection

A generic version of STERILE WATER FOR INJECTION was approved as sterile water for injection by HOSPIRA on October 27th, 1982.

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US Patents and Regulatory Information for STERILE WATER FOR INJECTION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Icu Medcl STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 019869-001 Dec 26, 1989 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Taro STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 077393-001 Aug 11, 2006 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Am Regent STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 217341-001 Aug 29, 2023 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Medefil Inc STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 211188-005 Dec 2, 2019 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 018632-001 Jun 30, 1982 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 212735-001 Jan 31, 2023 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 209689-001 Nov 24, 2017 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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