ELCYS Drug Patent Profile
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 is one drug master file entry 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
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 15, 2039. This may change due to patent challenges or generic licensing.
There have been five 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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Questions you can ask:
- What is the 5 year forecast for ELCYS?
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Summary for ELCYS
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ELCYS
Generic Entry Date for ELCYS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ELCYS is ⤷ Start Trial.
This potential generic entry date is based on patent 10,653,719.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| 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 | 11,510,942 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 10,905,713 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 10,583,155 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 11,679,125 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 10,905,714 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660-001 | Apr 16, 2019 | RX | Yes | Yes | 11,510,941 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
