Details for Patent: 11,510,942
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Summary for Patent: 11,510,942
Title: | Stable, highly pure L-cysteine compositions for injection and methods of use |
Abstract: | The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cysteine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace Othat is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use. |
Inventor(s): | Maloney John, Koganti Aruna, Koneru Phanesh |
Assignee: | EXELA PHARMA SCIENCES, LLC |
Application Number: | US17188922 |
Patent Claim Types: see list of patent claims | More… ↓ |
Drugs Protected by US Patent 11,510,942
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 11,510,942 | ⤷ Subscribe | Y | METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION | ⤷ Subscribe | |||
Baxter Hlthcare Corp | NOURESS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 212535-001 | Dec 13, 2019 | DISCN | Yes | No | 11,510,942 | ⤷ Subscribe | Y | METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION | ⤷ Subscribe | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |