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
Summary for ELCYS
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Patent Applications: | 2,588 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ELCYS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELCYS |
| What excipients (inactive ingredients) are in ELCYS? | ELCYS excipients list |
| DailyMed Link: | ELCYS at DailyMed |
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
