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Last Updated: March 29, 2024

RITONAVIR Drug Patent Profile


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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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Paragraph IV (Patent) Challenges for RITONAVIR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NORVIR Tablets ritonavir 100 mg 022417 1 2010-12-21

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

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