LIVDELZI Drug Patent Profile
✉ Email this page to a colleague
When do Livdelzi patents expire, and what generic alternatives are available?
Livdelzi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are six patents protecting this drug.
The generic ingredient in LIVDELZI is seladelpar lysine. There is one drug master file entry for this compound. 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, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for LIVDELZI?
- What are the global sales for LIVDELZI?
- What is Average Wholesale Price for LIVDELZI?
Summary for LIVDELZI
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 49 |
| 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:
TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA 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 two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LIVDELZI is ⤷ Start Trial.
This potential generic entry date is based on TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LIVDELZI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LIVDELZI
When does loss-of-exclusivity occur for LIVDELZI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Cyprus
Patent: 16249
Estimated Expiration: ⤷ Start Trial
Finland
Patent: 0253005
Estimated Expiration: ⤷ Start Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering LIVDELZI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2015231232 | ⤷ Start Trial | |
| Australia | 2017274293 | ⤷ Start Trial | |
| Brazil | 112016020260 | ⤷ Start Trial | |
| Brazil | 112018074147 | ⤷ Start Trial | |
| Canada | 2941401 | ⤷ Start Trial | |
| Canada | 3024155 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LIVDELZI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3119384 | C20253004 | Finland | ⤷ Start Trial | |
| 1937065 | C20253005 | Finland | ⤷ Start Trial | |
| 1937065 | CA 2025 00024 | Denmark | ⤷ Start Trial | PRODUCT NAME: L-LYSINSALT AF SELADELPAR, ISAER SELADELPAR-L-LYSIN-DIHYDRAT; REG. NO/DATE: EU/1/24/1898 20250221 |
| 3119384 | CA 2025 00025 | Denmark | ⤷ Start Trial | PRODUCT NAME: SELADELPAR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER SELADELPAR-L-LYSIN-DIHYDRAT; REG. NO/DATE: EU/1/24/1898 20250221 |
| 3119384 | PA2025529 | Lithuania | ⤷ Start Trial | PRODUCT NAME: SELADELPARAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA, YPAC SELADELPARO L-LIZINODIHIDRATAS; REGISTRATION NO/DATE: EU/1/24/1898 20250220 |
| 3119384 | 301338 | Netherlands | ⤷ Start Trial | PRODUCT NAME: SELADELPAR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER SELADELPAR-L-LYSINEDIHYDRAAT; REGISTRATION NO/DATE: EU/1/24/1898 20250221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch