Lenacapavir sodium - Generic Drug Details
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What are the generic drug sources for lenacapavir sodium and what is the scope of patent protection?
Lenacapavir sodium
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lenacapavir sodium has one hundred and sixty-nine patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for lenacapavir sodium
| International Patents: | 169 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| What excipients (inactive ingredients) are in lenacapavir sodium? | lenacapavir sodium excipients list |
| DailyMed Link: | lenacapavir sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lenacapavir sodium
Generic Entry Dates for lenacapavir sodium*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SOLUTION;SUBCUTANEOUS |
Generic Entry Dates for lenacapavir sodium*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;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 lenacapavir sodium
US Patents and Regulatory Information for lenacapavir sodium
| 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 | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 215973-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 215973-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 lenacapavir sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 118856 | COMPUESTOS TERAPÉUTICOS | ⤷ Try a Trial |
| Mexico | 2015011478 | COMPUESTOS DE AMIDA PARA EL TRATAMIENTO DE VIH. (AMIDE COMPOUNDS FOR THE TREATMENT OF HIV.) | ⤷ Try a Trial |
| Japan | 6893899 | ⤷ Try a Trial | |
| Brazil | 112018071678 | compostos terapêuticos úteis para o tratamento profilático ou terapêutico de uma infecção por vírus hiv | ⤷ Try a Trial |
| Denmark | 2961742 | ⤷ Try a Trial | |
| Canada | 3007006 | COMPOSES AMIDES DESTINES AU TRAITEMENT DU VIH (AMIDE COMPOUNDS FOR THE TREATMENT OF HIV) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lenacapavir sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3347352 | 55/2022 | Austria | ⤷ Try a Trial | PRODUCT NAME: LENACAPAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, INSBESONDERE LENACAPAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 (MITTEILUNG) 20220819 |
| 3347352 | 22C1063 | France | ⤷ Try a Trial | PRODUCT NAME: LENACAPAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LENACAPAVIR SODIQUE; REGISTRATION NO/DATE: EU/1/22/1671 20220819 |
| 3347352 | C202330002 | Spain | ⤷ Try a Trial | PRODUCT NAME: LENACAPAVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR LENACAPAVIR SODICO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1671; DATE OF AUTHORISATION: 20220817; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1671; DATE OF FIRST AUTHORISATION IN EEA: 20220817 |
| 3347352 | CA 2022 00052 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LENACAPAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NATRIUM-LENACAPAVIR; REG. NO/DATE: EU/1/22/1671 20220819 |
| 3347352 | C03347352/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LENACAPAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68386 07.07.2023 |
| 3347352 | PA2023501 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LENAKAPAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC LENAKAPAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/22/1671/001-002 20220817 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
