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Last Updated: November 22, 2024

ELCYS Drug Patent 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 sixteen 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. Two suppliers are listed for this compound. Additional details are available on the cysteine hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Elcys

There have been three 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.

There is one tentative approval for the generic drug (cysteine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for ELCYS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ELCYS Injection cysteine hydrochloride 500 mg/10 mL 210660 1 2019-12-10

US Patents and Regulatory Information for ELCYS

ELCYS is protected by sixteen US patents.

Patents protecting ELCYS

Stable, highly pure L-cysteine compositions for injection and methods of use
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Patented Use: METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION

Stable, highly pure L-cysteine compositions for injection and methods of use
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Patented Use: METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION

Stable, highly pure L-cysteine compositions for injection and methods of use
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Stable, highly pure L-cysteine compositions for injection and methods of use
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Stable, highly pure L-cysteine compositions for injection and methods of use
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Stable, highly pure L-cysteine compositions for injection and methods of use
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Patent Expiration: ⤷  Sign Up

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION


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Patented Use: METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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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