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Last Updated: November 17, 2024

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ZILBRYSQ Drug Patent Profile


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Which patents cover Zilbrysq, and what generic alternatives are available?

Zilbrysq is a drug marketed by Ucb Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and thirty-four patent family members in thirty countries.

The generic ingredient in ZILBRYSQ is zilucoplan sodium. One supplier is listed for this compound. Additional details are available on the zilucoplan sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Zilbrysq

Zilbrysq will be eligible for patent challenges on October 17, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 17, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZILBRYSQ
International Patents:134
US Patents:9
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Drug Prices: Drug price information for ZILBRYSQ
What excipients (inactive ingredients) are in ZILBRYSQ?ZILBRYSQ excipients list
DailyMed Link:ZILBRYSQ at DailyMed
Drug patent expirations by year for ZILBRYSQ
Drug Prices for ZILBRYSQ

See drug prices for ZILBRYSQ

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZILBRYSQ
Generic Entry Date for ZILBRYSQ*:
Constraining patent/regulatory exclusivity:
TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE
NDA:
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 ZILBRYSQ
Drug ClassComplement Inhibitor
Mechanism of ActionComplement Inhibitors

US Patents and Regulatory Information for ZILBRYSQ

ZILBRYSQ is protected by nine US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZILBRYSQ is ⤷  Sign Up.

This potential generic entry date is based on TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZILBRYSQ

Modulation of complement activity
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

Modulation of complement activity
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

Modulation of complement activity
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

Modulation of complement activity
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modulators of complement activity
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting ZILBRYSQ

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE
Exclusivity Expiration: ⤷  Sign Up

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 216834-003 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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 ⤷  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 216834-001 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up 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

International Patents for ZILBRYSQ

See the table below for patents covering ZILBRYSQ around the world.

Country Patent Number Title Estimated Expiration
Poland 3389692 ⤷  Sign Up
Singapore 11201610222U MODULATION OF COMPLEMENT ACTIVITY ⤷  Sign Up
China 111187338 补体活性的调节 (MODULATION OF COMPLEMENT ACTIVITY) ⤷  Sign Up
South Korea 102503319 ⤷  Sign Up
Cyprus 1124761 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZILBRYSQ

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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