RITONAVIR Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Ritonavir, and when can generic versions of Ritonavir launch?
Ritonavir is a drug marketed by Hikma, Amneal, Aurobindo Pharma Ltd, Cipla, and Hetero Labs Ltd Iii. and is included in six NDAs.
The generic ingredient in RITONAVIR is ritonavir. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ritonavir profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ritonavir
A generic version of RITONAVIR was approved as ritonavir by CIPLA on January 15th, 2015.
Summary for RITONAVIR
Recent Clinical Trials for RITONAVIR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Taiwan University Hospital | Phase 2/Phase 3 |
Karolinska Institutet | Phase 2 |
Haukeland University Hospital | Phase 3 |
Pharmacology for RITONAVIR
Medical Subject Heading (MeSH) Categories for RITONAVIR
Anatomical Therapeutic Chemical (ATC) Classes for RITONAVIR
US Patents and Regulatory Information for RITONAVIR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | RITONAVIR | ritonavir | CAPSULE;ORAL | 205801-001 | Dec 3, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cipla | RITONAVIR | ritonavir | TABLET;ORAL | 202573-001 | Jan 15, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Amneal | RITONAVIR | ritonavir | TABLET;ORAL | 208890-001 | Sep 17, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Aurobindo Pharma Ltd | RITONAVIR | ritonavir | TABLET;ORAL | 206614-001 | Sep 17, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hetero Labs Ltd Iii | RITONAVIR | ritonavir | TABLET;ORAL | 204587-001 | Sep 17, 2018 | AB | RX | 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 RITONAVIR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Mylan S.A.S | Ritonavir Mylan | ritonavir | EMEA/H/C/004549 Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV 1 infected patients (adults and children of 2 years of age and older). |
Authorised | yes | no | no | 2017-11-09 | |
AbbVie Deutschland GmbH Co. KG | Norvir | ritonavir | EMEA/H/C/000127 Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older). |
Authorised | no | no | no | 1996-08-25 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |