Sofosbuvir - Generic Drug Details
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What are the generic drug sources for sofosbuvir and what is the scope of freedom to operate?
Sofosbuvir
is the generic ingredient in four branded drugs marketed by Gilead Sciences Inc and Teva Pharms Usa Inc, and is included in six NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sofosbuvir has three hundred and sixty-two patent family members in forty-eight countries.
There are nine drug master file entries for sofosbuvir. One supplier is listed for this compound.
Summary for sofosbuvir
International Patents: | 362 |
US Patents: | 22 |
Tradenames: | 4 |
Applicants: | 2 |
NDAs: | 6 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 323 |
Patent Applications: | 1,592 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sofosbuvir |
What excipients (inactive ingredients) are in sofosbuvir? | sofosbuvir excipients list |
DailyMed Link: | sofosbuvir at DailyMed |
Recent Clinical Trials for sofosbuvir
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
UNITAID | Early Phase 1 |
Médecins du Monde | Early Phase 1 |
International Network of People who Use Drugs | Early Phase 1 |
Pharmacology for sofosbuvir
Drug Class | Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor |
Mechanism of Action | RNA Replicase Inhibitors |
Medical Subject Heading (MeSH) Categories for sofosbuvir
Anatomical Therapeutic Chemical (ATC) Classes for sofosbuvir
Paragraph IV (Patent) Challenges for SOFOSBUVIR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SOVALDI | Tablets | sofosbuvir | 400 mg | 204671 | 2 | 2017-12-06 |
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 | ⤷ Sign Up | |||
Gilead Sciences Inc | SOVALDI | sofosbuvir | PELLETS;ORAL | 212480-001 | Aug 28, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | PELLETS;ORAL | 214187-002 | Jun 10, 2021 | 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 | ⤷ Sign Up | |||
Gilead Sciences Inc | SOVALDI | sofosbuvir | TABLET;ORAL | 204671-001 | Dec 6, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 |
EU/EMA Drug Approvals for sofosbuvir
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Ireland UC | Sovaldi | sofosbuvir | EMEA/H/C/002798 Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. |
Authorised | no | no | no | 2014-01-16 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for sofosbuvir
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2011235112 | ⤷ Sign Up | |
Montenegro | 03009 | METODE ZA LECENJE HCV-A (METHODS FOR TREATING HCV) | ⤷ Sign Up |
Eurasian Patent Organization | 201490903 | КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ВИРУСНОГО ГЕПАТИТА C | ⤷ Sign Up |
Philippines | 12015502237 | N- [ (2 ` R) -2 ` -DEOXY-2 ` -FLUORO-2 ` -METHYL-P-PHENYL-5 ` -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION | ⤷ Sign Up |
Taiwan | 201139457 | Stereoselective synthesis of phosphorus containing actives | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sofosbuvir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2203462 | 67/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117 |
2203462 | 2014/065 | Ireland | ⤷ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116 |
2203462 | C20140035 00135 | Estonia | ⤷ Sign Up | PRODUCT NAME: SOFOSBUVIIR |
2203462 | 92600 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117 |
2203462 | C300704 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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