Sofosbuvir - Generic Drug Details
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What are the generic 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 fifty-four patent family members in forty-seven countries.
There are nine drug master file entries for sofosbuvir.
Summary for sofosbuvir
International Patents: | 354 |
US Patents: | 22 |
Tradenames: | 4 |
Applicants: | 2 |
NDAs: | 6 |
Drug Master File Entries: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 101 |
Clinical Trials: | 319 |
Patent Applications: | 2,665 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Peking University People's Hospital | Phase 4 |
Tanta University | Phase 3 |
The University of Queensland | Phase 4 |
Medical Subject Heading (MeSH) Categories 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
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 |
---|---|---|---|
Serbia | 56975 | METODE ZA LEÄŒENJE HCV-A (METHODS FOR TREATING HCV) | See Plans and Pricing |
Japan | 2012527477 | See Plans and Pricing | |
South Korea | 101599183 | See Plans and Pricing | |
Spain | 2817886 | See Plans and Pricing | |
Spain | 2900773 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sofosbuvir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2203462 | 132014902310732 | Italy | See Plans and Pricing | PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117 |
2203462 | PA2014040,C2203462 | Lithuania | See Plans and Pricing | PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
2203462 | PA2014040 | Lithuania | See Plans and Pricing | PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
2203462 | 2014029 | Norway | See Plans and Pricing | PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117 |
2203462 | CR 2014 00061 | Denmark | See Plans and Pricing | PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |