sunlenca Drug Patent Profile
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Which patents cover Sunlenca, and when can generic versions of Sunlenca launch?
Sunlenca is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are five patents protecting this drug.
This drug has one hundred and eighty-four patent family members in forty-five countries.
The generic ingredient in SUNLENCA is lenacapavir sodium. One supplier is listed for this compound. Additional details are available on the lenacapavir sodium profile page.
DrugPatentWatch® Generic Entry Outlook for Sunlenca
Sunlenca will be eligible for patent challenges on December 22, 2026. 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 December 22, 2027. 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 sunlenca?
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Summary for sunlenca
International Patents: | 184 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 20 |
Drug Prices: | Drug price information for sunlenca |
What excipients (inactive ingredients) are in sunlenca? | sunlenca excipients list |
DailyMed Link: | sunlenca at DailyMed |
![sunlenca drug patent expirations Drug patent expirations by year for sunlenca](/p/graph/s/t/sunlenca-patent-expirations.png)
![Drug Prices for sunlenca](/p/graph/drug-price/sunlenca.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for sunlenca
Generic Entry Dates for sunlenca*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
Dosage:
SOLUTION;SUBCUTANEOUS |
Generic Entry Dates for sunlenca*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
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.
US Patents and Regulatory Information for sunlenca
sunlenca is protected by five US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of sunlenca 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 sunlenca
Therapeutic compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Therapeutic compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL(S), FOR THE TREATMENT OF HIV-1 INFECTION IN HEAVILY-TREATMENT EXPERIENCED ADULTS WITH MULTIDRUG RESISTANT HIV-1 INFECTION
Solid forms of an HIV capsid inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL(S), FOR THE TREATMENT OF HIV-1 INFECTION IN HEAVILY-TREATMENT EXPERIENCED ADULTS WITH MULTIDRUG RESISTANT HIV-1 INFECTION
Therapeutic compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL(S), FOR THE TREATMENT OF HIV-1 INFECTION IN HEAVILY-TREATMENT EXPERIENCED ADULTS WITH MULTIDRUG RESISTANT HIV-1 INFECTION
FDA Regulatory Exclusivity protecting sunlenca
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 215973-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 215973-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 sunlenca
See the table below for patents covering sunlenca around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112015021027 | compostos terapêuticos | ⤷ Sign Up |
South Korea | 20230141905 | HIV의 치료를 위한 캡시드 억제제 (HIV CAPSID INHIBITORS FOR THE TREATMENT OF HIV) | ⤷ Sign Up |
Philippines | 12019500335 | THERAPEUTIC COMPOUNDS USEFUL FOR THE PROPHYLACTIC OR THERAPEUTIC TREATMENT OF AN HIV VIRUS INFECTION | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sunlenca
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3347352 | 122022000082 | Germany | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE LENACAPAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 20220817 |
3347352 | 22C1063 | France | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LENACAPAVIR SODIQUE; REGISTRATION NO/DATE: EU/1/22/1671 20220819 |
3347352 | 55/2022 | Austria | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, INSBESONDERE LENACAPAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 (MITTEILUNG) 20220819 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |