RITONAVIR Drug Patent Profile
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Which patents cover Ritonavir, and when can generic versions of Ritonavir launch?
Ritonavir is a drug marketed by Hikma, Norvium Bioscience, Amneal, Aurobindo Pharma Ltd, Cipla, and Hetero Labs Ltd Iii. and is included in seven NDAs.
The generic ingredient in RITONAVIR is ritonavir. There are twenty-one drug master file entries for this compound. Seven 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.
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Questions you can ask:
- What is the 5 year forecast for RITONAVIR?
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- What is Average Wholesale Price for RITONAVIR?
Summary for RITONAVIR
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Clinical Trials: | 1,019 |
| Drug Prices: | Drug price information for RITONAVIR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RITONAVIR |
| DailyMed Link: | RITONAVIR at DailyMed |
Recent Clinical Trials for RITONAVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Zimbabwe Clinical Research Centre (UZCRC) | Phase 1/Phase 2 |
| Centre Hospitalier National d'Enfants Albert Royer | Phase 1/Phase 2 |
| Institut National de la Santé Et de la Recherche Médicale, France | Phase 1/Phase 2 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hetero Labs Ltd Iii | RITONAVIR | ritonavir | TABLET;ORAL | 204587-001 | Sep 17, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Ltd | RITONAVIR | ritonavir | TABLET;ORAL | 206614-001 | Sep 17, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 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 |
