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Last Updated: November 17, 2024

ZILUCOPLAN SODIUM - Generic Drug Details


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What are the generic drug sources for zilucoplan sodium and what is the scope of freedom to operate?

Zilucoplan sodium is the generic ingredient in one branded drug marketed by Ucb Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zilucoplan sodium has one hundred and thirty-four patent family members in thirty countries.

One supplier is listed for this compound.

Summary for ZILUCOPLAN SODIUM
International Patents:134
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:ZILUCOPLAN SODIUM at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZILUCOPLAN SODIUM
Generic Entry Date for ZILUCOPLAN SODIUM*:
Constraining patent/regulatory exclusivity:
TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE
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 ZILUCOPLAN SODIUM
Drug ClassComplement Inhibitor
Mechanism of ActionComplement Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for ZILUCOPLAN SODIUM

US Patents and Regulatory Information for ZILUCOPLAN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ucb Inc ZILBRYSQ zilucoplan sodium SOLUTION;SUBCUTANEOUS 216834-002 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ucb Inc ZILBRYSQ zilucoplan sodium SOLUTION;SUBCUTANEOUS 216834-002 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ucb Inc ZILBRYSQ zilucoplan sodium SOLUTION;SUBCUTANEOUS 216834-002 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ucb Inc ZILBRYSQ zilucoplan sodium SOLUTION;SUBCUTANEOUS 216834-003 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ucb Inc ZILBRYSQ zilucoplan sodium SOLUTION;SUBCUTANEOUS 216834-003 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ZILUCOPLAN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3154561 301275 Netherlands ⤷  Sign Up PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 20231204
3154561 17/2024 Austria ⤷  Sign Up PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 (MITTEILUNG) 20231204
3154561 PA2024514 Lithuania ⤷  Sign Up PRODUCT NAME: ZILUKOPLANAS; REGISTRATION NO/DATE: EU/1/23/1764 20231201
3154561 LUC00343 Luxembourg ⤷  Sign Up PRODUCT NAME: ZILUCOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1764 20231204
3154561 2024C/518 Belgium ⤷  Sign Up PRODUCT NAME: ZILUCOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1764 20231204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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