Details for New Drug Application (NDA): 210660
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NDA 210660 describes ELCYS, which is a drug marketed by Exela Pharma and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the ELCYS profile page.
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.
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.
Summary for 210660
| Tradename: | ELCYS |
| Applicant: | Exela Pharma |
| Ingredient: | cysteine hydrochloride |
| Patents: | 16 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210660
Generic Entry Date for 210660*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 210660
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660 | NDA | Exela Pharma Sciences, LLC | 51754-1007 | 51754-1007-1 | 10 mL in 1 VIAL (51754-1007-1) |
| ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660 | NDA | Exela Pharma Sciences, LLC | 51754-1007 | 51754-1007-3 | 100 mL in 1 CARTON (51754-1007-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/10ML (50MG/ML) | ||||
| Approval Date: | Apr 16, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 15, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 15, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 15, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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