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Sofosbuvir - Generic Drug Details
What are the generic sources for sofosbuvir and what is the scope of sofosbuvir freedom to operate?
Sofosbuvir
is the generic ingredient in three branded drugs marketed by Gilead Sciences Inc and is included in three NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for sofosbuvir. One supplier is listed for this compound.
Summary for sofosbuvir
| US Patents: | 17 |
| Tradenames: | 3 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: | 9 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 58 |
| Clinical Trials: | 230 |
| Patent Applications: | 186 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sofosbuvir |
| DailyMed Link: | sofosbuvir at DailyMed |
Pharmacology for sofosbuvir
| Ingredient-type | Nucleoside Analog |
| Drug Class | Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor |
| Mechanism of Action | RNA Replicase Inhibitors |
Medical Subject Heading (MeSH) Categories for sofosbuvir
Synonyms for sofosbuvir
| (S)-2-{[(1R,4R,5R)-5-(2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-(R)-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-ylmethoxy]phenoxyphosphorylamino}propionic acid (S)-isopropyl ester |
| (S)-isopropyl 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)amino)propanoate |
| 1064684-44-1 |
| 1190307-88-0 |
| 1221574-17-9 |
| 1421833-87-5 |
| 2-((5-(2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-ylmethoxy)phenoxyphosphorylamino)propionic acid isopropyl ester |
| AB0109660 |
| AC-27382 |
| AK172330 |
| AKOS024464753 |
| AKOS025401925 |
| AM013398 |
| AM84279 |
| AMMD00019 |
| AMX10213 |
| AOB6269 |
| AS-19600 |
| C22H29FN3O9P |
| CHEBI:85083 |
| CHEMBL1258950 |
| CHEMBL1259059 |
| CS-0554 |
| D0A6OO |
| D0D4YZ |
| D10366 |
| DA-47516 |
| DB08934 |
| EX-A389 |
| GI 7977 |
| GI-7977 |
| GS 7977 |
| GS 7977;PSI 7977;sofosbuvir |
| GS-7977 |
| GS-9851 |
| GTPL7368 |
| Hepcinat |
| Hepcvir |
| HSDB 8226 |
| HY-15005 |
| isopropyl ((((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate |
| isopropyl ((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate |
| isopropyl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate |
| isopropyl (2S)-2-[[[(3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate |
| isopropyl (2S)-2-{[(S)-{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate |
| ISOPROPYL 2-({[5-(2,4-DIOXO-3H-PYRIMIDIN-1-YL)-4-FLUORO-3-HYDROXY-4-METHYLOXOLAN-2-YL]METHOXY(PHENOXY)PHOSPHORYL}AMINO)PROPANOATE |
| KB-80152 |
| L-Alanine, N-((2'R)-2'-deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl)-, 1-methylethyl ester |
| L-Alanine, N-((P(S),2'R)-2'-deoxy-2'-fluoro-2'-methyl-P-phenyl-5'-uridylyl)-, 1-methylethyl ester |
| MolPort-028-720-482 |
| MolPort-028-720-483 |
| N-((2'R)-2'-Deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl)-L-alanine 1-methylethyl ester |
| propan-2-yl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy-phenoxyphosphoryl]amino]propanoate |
| Propan-2-yl (2S)-2-{[{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate (non-preferred name) |
| psi 7851 |
| PSI 7977 |
| PSI-7851 |
| PSI-7977 |
| Psi-7977, sofosbuvir |
| Q-4112 |
| QC-10465 |
| Resof |
| S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4- dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)- (phenoxy)phosphorylamino)propanoate |
| s2794 |
| SC-87382 |
| SCHEMBL18061557 |
| SCHEMBL2003999 |
| SCHEMBL2010114 |
| Sofosbuvir (JAN/USAN) |
| Sofosbuvir [USAN:INN] |
| Sofosbuvir pound PSI7977 GS-7977 pound(c) |
| Sofosbuvir(PSI-7977) |
| SOVALDI |
| Sovaldi (TN) |
| SoviHep |
| UNII-3S5S1851OV component TTZHDVOVKQGIBA-IQWMDFIBSA-N |
| UNII-3S5S1851OV component TTZHDVOVKQGIBA-YBSJRAAASA-N |
| UNII-WJ6CA3ZU8B |
| WJ6CA3ZU8B |
| Y1293 |
| ZINC100074252 |
US Patents and Regulatory Information for sofosbuvir
| 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 | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195-001 | Jul 18, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195-001 | Jul 18, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195-001 | Jul 18, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Gilead Sciences Inc | VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195-001 | Jul 18, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-001 | Dec 6, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | 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 sofosbuvir
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2913337 | ➤ Sign Up |
| Spain | 2659216 | ➤ Sign Up |
| Japan | 2013523767 | ➤ Sign Up |
| China | 105198949 | ➤ Sign Up |
| Spain | 2638350 | ➤ Sign Up |
| Portugal | 2709613 | ➤ Sign Up |
| Japan | 5774749 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for sofosbuvir
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2014040,C2203462 | Lithuania | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 600 | Luxembourg | ➤ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117 |
| 2014040 | Lithuania | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 0704 | Netherlands | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2014000108 | Germany | ➤ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116 |
| C0082 | France | ➤ Sign Up | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 00704 | Netherlands | ➤ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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