Details for New Drug Application (NDA): 216834
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NDA 216834 describes ZILBRYSQ, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the ZILBRYSQ profile page.
The generic ingredient in ZILBRYSQ is zilucoplan sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the zilucoplan sodium profile page.
The generic ingredient in ZILBRYSQ is zilucoplan sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the zilucoplan sodium profile page.
Summary for 216834
| Tradename: | ZILBRYSQ |
| Applicant: | Ucb Inc |
| Ingredient: | zilucoplan sodium |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216834
Generic Entry Date for 216834*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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.
Pharmacology for NDA: 216834
| Mechanism of Action | Complement Inhibitors |
Suppliers and Packaging for NDA: 216834
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZILBRYSQ | zilucoplan sodium | SOLUTION;SUBCUTANEOUS | 216834 | NDA | UCB, Inc. | 50474-990 | 50474-990-80 | 4 CARTON in 1 BOX (50474-990-80) / 7 SYRINGE, GLASS in 1 CARTON / .416 mL in 1 SYRINGE, GLASS |
| ZILBRYSQ | zilucoplan sodium | SOLUTION;SUBCUTANEOUS | 216834 | NDA | UCB, Inc. | 50474-991 | 50474-991-80 | 4 CARTON in 1 BOX (50474-991-80) / 7 SYRINGE, GLASS in 1 CARTON / .574 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | ||||
| Approval Date: | Oct 17, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 17, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 17, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE | ||||||||
| Patent: | 10,106,579 | Patent Expiration: | Jun 12, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN AN ADULT PATIENT WHO IS ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE BY SUBCUTANEOUS ADMINISTRATION OF C5 COMPLEMENT INHIBITOR ZILUCOPLAN | ||||||||
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