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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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZILBRYSQ

Generic Entry Date for ZILBRYSQ^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF GENERALIZED MYASTHENIA GRAVIS (GMG) IN ADULT PATIENTS WHO ARE ANTI-ACETYLCHOLINE RECEPTOR (ACHR) ANTIBODY POSITIVE NDA: 216834 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 Class	Complement Inhibitor
Mechanism of Action	Complement 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

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

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

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Glossary

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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
>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.

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Country	Patent Number	Title	Estimated Expiration
Japan	2024001300	補体活性のモジュレーター	⤷ Sign Up
Brazil	122021025449	Composto, polipeptídeo e composição compreendendo o mesmo	⤷ Sign Up
Lithuania	3250230		⤷ Sign Up
Taiwan	I745320		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ZILBRYSQ

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3154561	17/2024	Austria	⤷ Sign Up	PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 (MITTEILUNG) 20231204
3154561	301275	Netherlands	⤷ Sign Up	PRODUCT NAME: ZILUCOPLAN; REGISTRATION NO/DATE: EU/1/23/1764 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description