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Last Updated: August 15, 2022

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Elcys

A generic version of ELCYS was approved as cysteine hydrochloride by DR REDDYS LABS SA on April 8th, 2022.

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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 eight US patents.

Patents protecting ELCYS

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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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Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
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Harvard Business School

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