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 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 |
---|---|---|---|
Japan | 2016155875 | 2種の抗ウイルス化合物のコンビナトリアル製剤 (COMBINATORIAL FORMULATION OF TWO KINDS OF ANTIVIRAL COMPOUNDS) | ⤷ Free Trial |
Croatia | P20140667 | ⤷ Free Trial | |
European Patent Office | 2873665 | Composés antiviraux (Antiviral compounds) | ⤷ Free Trial |
Spain | 2548156 | ⤷ Free Trial | |
Japan | 6106716 | ⤷ Free Trial | |
New Zealand | 623602 | N-[(2’r)-2’-deoxy-2’-fluoro-2’-methyl-p-phenyl-5’-uridylyl]-l-alanine 1-methylethyl ester and process for its production | ⤷ Free Trial |
Montenegro | 03009 | METODE ZA LECENJE HCV-A (METHODS FOR TREATING HCV) | ⤷ Free 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 | C 2014 043 | Romania | ⤷ Free 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 | SPC/GB16/008 | United Kingdom | ⤷ Free Trial | PRODUCT NAME: LEDIPASVIR; REGISTERED: UK EU/1/14/958(001-002) 20141118 |
2203462 | C20140035 | Estonia | ⤷ Free Trial | PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014 |
2203462 | 132014902310732 | Italy | ⤷ Free Trial | PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117 |
2430014 | 1690002-9 | Sweden | ⤷ Free Trial | PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141118 |
2430014 | 132016000015690 | Italy | ⤷ Free Trial | PRODUCT NAME: LEDIPASVIR(HARVONI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/958, 20141118 |
2203462 | 14C0082 | France | ⤷ Free Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Sofosbuvir/Ledipasvir (Harvoni)
More… ↓
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