SOFOSBUVIR Drug Patent Profile
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When do Sofosbuvir patents expire, and when can generic versions of Sofosbuvir launch?
Sofosbuvir is a drug marketed by Teva Pharms Usa Inc and is included in one NDA.
The generic ingredient in SOFOSBUVIR is sofosbuvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.
Summary for SOFOSBUVIR
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 322 |
| Patent Applications: | 757 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SOFOSBUVIR |
| DailyMed Link: | SOFOSBUVIR at DailyMed |
Recent Clinical Trials for SOFOSBUVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 4 |
| Peking University People's Hospital | Phase 4 |
| Tanta University | Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa Inc | SOFOSBUVIR | sofosbuvir | TABLET;ORAL | 211353-001 | Jan 27, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
