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 eight patents protecting this drug.
This drug has one hundred and thirty-two patent family members in twenty-nine 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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Questions you can ask:
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Summary for ZILBRYSQ
International Patents: | 132 |
US Patents: | 8 |
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 |
![ZILBRYSQ drug patent expirations Drug patent expirations by year for ZILBRYSQ](/p/graph/s/t/ZILBRYSQ-patent-expirations.png)
![Drug Prices for ZILBRYSQ](/p/graph/drug-price/ZILBRYSQ.png)
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 Class | Complement Inhibitor |
Mechanism of Action | Complement Inhibitors |
US Patents and Regulatory Information for ZILBRYSQ
ZILBRYSQ is protected by eight 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
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 | 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 | 216834-001 | 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 | 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 | 216834-001 | 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 |
---|---|---|---|
Serbia | 59353 | MODULACIJA AKTIVNOSTI KOMPLEMENTA (MODULATION OF COMPLEMENT ACTIVITY) | ⤷ Sign Up |
Argentina | 121381 | COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE MODULADORES DE ACTIVIDAD COMPLEMENTARIA Y DISPOSITIVO AUTOINYECTOR | ⤷ Sign Up |
Slovenia | 3685847 | ⤷ Sign Up | |
Spain | 2781551 | ⤷ Sign Up | |
New Zealand | 736573 | Modulation of complement activity | ⤷ Sign Up |
South Korea | 20220002727 | 보체 활성의 조절 (MODULATION OF COMPLEMENT ACTIVITY) | ⤷ Sign Up |
Cyprus | 1124595 | ⤷ 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 | LUC00343 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ZILUCOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1764 20231204 |
3154561 | CA 2024 00021 | Denmark | ⤷ Sign Up | PRODUCT NAME: ZILUCOPLAN; REG. NO/DATE: EU/1/23/1764 20231204 |
3154561 | PA2024514 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ZILUKOPLANAS; REGISTRATION NO/DATE: EU/1/23/1764 20231201 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |