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Last Updated: September 20, 2020

DrugPatentWatch Database Preview

Details for Patent: 10,478,453

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Which drugs does patent 10,478,453 protect, and when does it expire?

Patent 10,478,453 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,478,453
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; cystine 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 O.sub.2 that 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 (Salisbury, NC), Koganti; Aruna (Lenoir, NC), Koneru; Phanesh (Waxhaw, NC)
Assignee: Exela Pharma Sciences, LLC (Lenoir, NC)
Application Number:16/248,460
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,478,453
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Dosage form;

Drugs Protected by US Patent 10,478,453

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   Start Trial   Start Trial Y METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION   Start Trial
Exela Pharma NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No   Start Trial   Start Trial Y METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION   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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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Merck
McKesson
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McKinsey

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