Last Updated: June 22, 2026

STERILE Drug Patent Profile


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When do Sterile patents expire, and when can generic versions of Sterile launch?

Sterile is a drug marketed by Hospira, Baxter Hlthcare, Am Regent, Fresenius Kabi Usa, Hikma, Medefil Inc, Nephron, Nexus, B Braun, Otsuka Icu Medcl, Taro, and Miles. and is included in twenty-three NDAs.

The generic ingredient in STERILE is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.

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Summary for STERILE
US Patents:0
Applicants:12
NDAs:23
Drug Prices: Drug price information for STERILE
DailyMed Link:STERILE at DailyMed

US Patents and Regulatory Information for STERILE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa STERILE WATER FOR IRRIGATION sterile water for irrigation LIQUID;IRRIGATION 216123-001 Aug 12, 2024 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 088400-001 Jan 16, 1984 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun STERILE WATER IN PLASTIC CONTAINER sterile water for irrigation LIQUID;IRRIGATION 016734-001 Approved Prior to Jan 1, 1982 AT RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 018233-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira STERILE UREA urea INJECTABLE;INJECTION 017698-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Medefil Inc STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 211188-003 Dec 2, 2019 RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 019077-001 Mar 2, 1984 DISCN 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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