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Moodys

Last Updated: June 14, 2021

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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 and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

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.

DrugPatentWatch® Generic Entry Outlook for Elcys

There have been two patent litigation cases 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 ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ELCYS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0107734 93C0042 Belgium   Get Started Free PROD. NAME TETRAKIS (2-METHOXY-ISOBUTYL-ISONITRILE). CUIVRE (I) TETRAFLUOROBORATE, DIHYDRATE DE CHLORURE STANNEUX, CHLORHYDRATE DE L-CYSTEINE (MONOHYDRATE); REG NO/DATE 923 IS 3 F 12/ 19900924 ; FIRST REG CC NO DATE IE PA 200/9/1 19900817
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
McKinsey
Mallinckrodt
McKesson
Harvard Business School

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