LEDIPASVIR; SOFOSBUVIR - Generic Drug Details
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What are the generic sources for ledipasvir; sofosbuvir and what is the scope of patent protection?
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 fifty-five patent family members in forty-eight countries.
Two suppliers are listed for this compound.
Summary for LEDIPASVIR; SOFOSBUVIR
International Patents: | 555 |
US Patents: | 17 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 98 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEDIPASVIR; SOFOSBUVIR |
DailyMed Link: | LEDIPASVIR; SOFOSBUVIR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LEDIPASVIR; SOFOSBUVIR
Generic Entry Dates for LEDIPASVIR; SOFOSBUVIR*:
Constraining patent/regulatory exclusivity:
Dosage:
PELLETS;ORAL |
Generic Entry Dates for LEDIPASVIR; SOFOSBUVIR*:
Constraining patent/regulatory exclusivity:
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.
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 | 2910562 | Ester de N-[(2'r)-2'-deoxy-2'-fluoro-2'-méthyl-p-phényl-5'-uridylyl]-l-alanine-1-méthyléthyle en forme cristalline (N-[(2'r)-2'-deoxy-2 '-fluoro-2'-methyl-p-phenyl-5 '-uridylyl]-l-alanine 1-methylethyl ester in crystalline form) | ⤷ Try a Trial |
Canada | 2886322 | COMPOSES ANTIVIRAUX (ANTIVIRAL COMPOUNDS) | ⤷ Try a Trial |
Brazil | 112012024923 | "fosforamidatos de nucleosídeo, composição, comprimido, e seus usos" | ⤷ Try a Trial |
Montenegro | 02321 | Antivirusna jedinjenja (Antiviral compounds) | ⤷ Try a Trial |
European Patent Office | 2933260 | PROMÉDICAMENTS À BASE DE PHOSPHORAMIDATES NUCLÉOSIDIQUES (NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEDIPASVIR; SOFOSBUVIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2203462 | 67/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117 |
2203462 | C 2014 043 | Romania | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894(001-002); DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894(001-002); DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
2430014 | 2020046 | Norway | ⤷ Try a Trial | PRODUCT NAME: LEDIPASVIR - FORLENGET SPC; REG. NO/DATE: EU/1/14/958 20141203 |
2430014 | PA2016002,C2430014 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141117 |
2203462 | C20140035 00135 | Estonia | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIIR |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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