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.Seladelpar lysine has one hundred and twenty-six patent family members in forty-two countries.
One supplier is listed for this compound.
Summary for seladelpar lysine
| International Patents: | 126 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 14 |
| 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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | 11,596,614 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | 10,272,058 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | 7,709,682 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Gilead Sciences Inc | LIVDELZI | seladelpar lysine | CAPSULE;ORAL | 217899-001 | Aug 14, 2024 | RX | Yes | Yes | 7,301,050 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| >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 seladelpar lysine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Peru | 20070434 | ⤷ Subscribe | |
| Slovenia | 3463328 | ⤷ Subscribe | |
| Russian Federation | 2765460 | ЛЕЧЕНИЕ ВНУТРИПЕЧЕНОЧНЫХ ХОЛЕСТАТИЧЕСКИХ ЗАБОЛЕВАНИЙ (TREATMENT OF INTRAHEPATIC CHOLESTATIC DISEASES) | ⤷ Subscribe |
| Norway | 341448 | ⤷ Subscribe | |
| China | 106102734 | 肝内胆汁淤积性疾病的治疗 (Treatment of intrahepatic cholestatic diseases) | ⤷ Subscribe |
| Serbia | 63345 | SELADELPAR ZA LEČENJE PRIMARNOG BILIJARNOG HOLANGITISA (SELADELPAR FOR THE TREATMENT OF PRIMARY BILIARY CHOLANGITIS) | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
