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Last Updated: April 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 fifteen 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 fifteen US patents.

Patents protecting ELCYS

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable, highly pure L-cysteine compositions for injection and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


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Patent Expiration: ⤷  Try a Trial


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Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-002 Dec 4, 2023 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.