Details for New Drug Application (NDA): 219745
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NDA 219745 describes CAMCEVI ETM, which is a drug marketed by Accord and is included in one NDA. There are five patents protecting this drug. Additional details are available on the CAMCEVI ETM profile page.
The generic ingredient in CAMCEVI ETM is leuprolide mesylate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the leuprolide mesylate profile page.
The generic ingredient in CAMCEVI ETM is leuprolide mesylate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the leuprolide mesylate profile page.
Summary for 219745
| Tradename: | CAMCEVI ETM |
| Applicant: | Accord |
| Ingredient: | leuprolide mesylate |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219745
Generic Entry Date for 219745*:
Constraining patent/regulatory exclusivity:
Dosage:
EMULSION;SUBCUTANEOUS |
*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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;SUBCUTANEOUS | Strength | EQ 21MG BASE | ||||
| Approval Date: | Aug 25, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 25, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW STRENGTH | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 16, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 1, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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