LIVDELZI Drug Patent Profile
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When do Livdelzi patents expire, and what generic alternatives are available?
Livdelzi is a drug marketed by Cymabay and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and twenty-six patent family members in forty-two countries.
The generic ingredient in LIVDELZI is seladelpar lysine. One supplier is listed for this compound. Additional details are available on the seladelpar lysine profile page.
DrugPatentWatch® Generic Entry Outlook for Livdelzi
Livdelzi will be eligible for patent challenges on August 14, 2028. 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 August 14, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for LIVDELZI?
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Summary for LIVDELZI
International Patents: | 126 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
What excipients (inactive ingredients) are in LIVDELZI? | LIVDELZI excipients list |
DailyMed Link: | LIVDELZI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LIVDELZI
Generic Entry Date for LIVDELZI*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
Dosage:
CAPSULE;ORAL |
*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.
US Patents and Regulatory Information for LIVDELZI
LIVDELZI is protected by six US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LIVDELZI is ⤷ Sign Up.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
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 LIVDELZI
Treatment of intrahepatic cholestatic diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Treatment of intrahepatic cholestatic diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
FDA Regulatory Exclusivity protecting LIVDELZI
NEW CHEMICAL ENTITY
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cymabay | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cymabay | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cymabay | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cymabay | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cymabay | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 LIVDELZI
See the table below for patents covering LIVDELZI around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 3119384 | ⤷ Sign Up | |
Honduras | 2006032171 | ⤷ Sign Up | |
Brazil | PI0414268 | ⤷ Sign Up | |
European Patent Office | 1937065 | ⤷ Sign Up | |
Portugal | 3119384 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |