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Last Updated: August 12, 2020

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ELCYS Drug Profile

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Which patents cover Elcys, and when can generic versions of Elcys launch?

Elcys is a drug marketed by Exela Pharma Scs Llc and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in ELCYS is cysteine hydrochloride. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cysteine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Elcys

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for ELCYS
Tradename Dosage Ingredient NDA Submissiondate
ELCYS SOLUTION;INTRAVENOUS cysteine hydrochloride 210660 2019-12-10

US Patents and Regulatory Information for ELCYS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exela Pharma Scs Llc ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Exela Pharma Scs Llc ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 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. >Exclusivity Expiration

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Harvard Business School

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