Ledipasvir; sofosbuvir - Generic Drug Details
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What are the generic sources for ledipasvir; sofosbuvir and what is the scope of freedom to operate?
Ledipasvir; sofosbuvir
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ledipasvir; sofosbuvir has five hundred and forty-three patent family members in forty-seven countries.
One supplier is listed for this compound.
Summary for ledipasvir; sofosbuvir
International Patents: | 543 |
US Patents: | 17 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 98 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ledipasvir; sofosbuvir |
DailyMed Link: | ledipasvir; sofosbuvir at DailyMed |
Recent Clinical Trials for ledipasvir; sofosbuvir
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mansoura University | Phase 3 |
Helwan University | Phase 4 |
Cairo University | Phase 2/Phase 3 |
Pharmacology for ledipasvir; sofosbuvir
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2552933 | HYDRATE DE L'ISOPROPYL ESTER DE L'ACIDE (S)-2-{(S)-[(1R,4R,5R)-5-(2-AMINO-6-METHOXY- PURIN-9-YL)-4-(R)-FLUORO-3-HYDROXY-4-METHYL-TETRAHYDRO-FURAN-2-YLMETHOXY]- PHENOXY-PHOSPHORYLAMINO}-PROPIONIQUE DANS L'UTILISATION POUR LE TRAITEMENT DU VHC ((S)-2-{(S)-[(1R,4R,5R)-5-(2-AMINO-6-METHOXY- PURIN-9-YL)-4-(R)-FLUORO-3-HYDROXY-4-METHYL-TETRAHYDRO-FURAN-2-YLMETHOXY]- PHENOXY-PHOSPHORYLAMINO}-PROPIONIC ACID ISOPROPYL ESTER HYDRATE FOR USE IN TREATING HCV) | See Plans and Pricing |
Brazil | 112012024923 | "fosforamidatos de nucleosídeo, composição, comprimido, e seus usos" | See Plans and Pricing |
Israel | 216254 | תרכובות , הרכבים פרמצבטיים ושימושים שלהם (Compounds, pharmaceutical compositions comprising the same and uses thereof) | See Plans and Pricing |
Taiwan | 201136593 | Nucleoside phosphoramidates | See Plans and Pricing |
Brazil | 112014012739 | composições e métodos para o tratamento do vírus da hepatite c | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ledipasvir; sofosbuvir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2430014 | 122016000009 | Germany | See Plans and Pricing | PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117 |
2430014 | C201630002 | Spain | See Plans and Pricing | PRODUCT NAME: LEDIPASVIR; NATIONAL AUTHORISATION NUMBER: EU/1/14/958; DATE OF AUTHORISATION: 20141117; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/958; DATE OF FIRST AUTHORISATION IN EEA: 20141117 |
2430014 | 4/2016 | Austria | See Plans and Pricing | PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 (MITTEILUNG) 20141118 |
2203462 | 122014000108 | Germany | See Plans and Pricing | PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116 |
2430014 | C20160002 | Estonia | See Plans and Pricing | PRODUCT NAME: LEDIPASVIIR; NATIONAL AUTHORISATION NUMBER: EMA/498767/2019; DATE OF AUTHORISATION: 20200430 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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