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 |
|---|---|---|---|
| Hong Kong | 1199645 | 含磷活性物質的立體選擇性合成 (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES) | ⤷ Try a Trial |
| Chile | 2010000520 | Forma cristalina del propanoato de (s) - isopropil 2 -(((s) - (((2r,3r,4r,5r) - 5- (2,4-dioxo-3,4-dihidropirimidim-1(2h) -il)-4-fluoro-3-hidroxi-4-metitetrahidrofuran-2-il)metoxi)(fenoxi)fosforil)amino); proceso de preparacion; composicion framaceutica; y su uso para el tratamiento de una infeccion causada por el virus de la hepatitis c. | ⤷ Try a Trial |
| South Korea | 20120034801 | NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS | ⤷ Try a Trial |
| China | 102858790 | Nucleoside Phosphoramidates | ⤷ Try a Trial |
| Slovenia | 2801580 | ⤷ Try a Trial | |
| Japan | 5872539 | ⤷ Try a Trial | |
| Singapore | 176197 | N- [ (2 ' R) -2 ' -DEOXY-2 ' -FLUORO-2 ' -METHYL-P-PHENYL-5 ' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION | ⤷ 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 |
|---|---|---|---|---|
| 2430014 | PA2016002,C2430014 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141117 |
| 2203462 | C02203462/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014 |
| 2203462 | 300704 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2203462 | C20140035 | Estonia | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014 |
| 2203462 | CA 2014 00061 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116 |
| 2430014 | SPC/GB16/008 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LEDIPASVIR; REGISTERED: UK EU/1/14/958(001-002) 20141118 |
| 2203462 | PA2014040 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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