Seladelpar lysine - Generic Drug Details
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What are the generic drug sources for seladelpar lysine and what is the scope of freedom to operate?
Seladelpar lysine
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for seladelpar lysine
| International Patents: | 138 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 89 |
| What excipients (inactive ingredients) are in seladelpar lysine? | seladelpar lysine excipients list |
| DailyMed Link: | seladelpar lysine at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for seladelpar lysine
Generic Entry Date for seladelpar lysine*:
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 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.
Anatomical Therapeutic Chemical (ATC) Classes for seladelpar lysine
US Patents and Regulatory Information for seladelpar lysine
| 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 | 11,406,611 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | 9,486,428 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | 10,272,058 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | 7,301,050 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | 7,709,682 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | 11,596,614 | ⤷ 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 seladelpar lysine
| 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 | 7,301,050 | ⤷ Start Trial |
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | 7,709,682 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for seladelpar lysine
| 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 | |
| Chile | 2016002338 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for seladelpar lysine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3119384 | 2025C/532 | Belgium | ⤷ Start Trial | PRODUCT NAME: SELADELPAR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER SELADELPAR L-LYSINEDIHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/24/1898 20250221 |
| 3119384 | LUC50017 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: SELADELPAR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR SELADELPAR L-LYSINE DIHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/24/1898 20250221 |
| 3119384 | 26/2025 | Austria | ⤷ Start Trial | PRODUCT NAME: SELADELPAR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE SELADELPAR-L-LYSIN-DIHYDRAT; REGISTRATION NO/DATE: EU/1/24/1898 (MITTEILUNG) 20250221 |
| 1937065 | C20253005 | Finland | ⤷ Start Trial | |
| 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 | 25C1031 | France | ⤷ Start Trial | PRODUCT NAME: SELADELPAR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CE DERNIER, EN PARTICULIER SELADELPAR L-LYSINE DIHYDRATE; REGISTRATION NO/DATE: EU/1/24/1898 20250221 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
