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Last Updated: December 8, 2022

Ritonavir - Generic Drug Details


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What are the generic sources for ritonavir and what is the scope of patent protection?

Ritonavir is the generic ingredient in two branded drugs marketed by Abbott, Abbvie, Hikma, Abbvie Inc, Amneal, Aurobindo Pharma Ltd, Cipla, and Hetero Labs Ltd Iii, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for ritonavir. Eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for ritonavir

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Recent Clinical Trials for ritonavir

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wisconsin Partnership ProgramPhase 1
University of Wisconsin, MadisonPhase 1
Johns Hopkins UniversityPhase 1/Phase 2

See all ritonavir clinical trials

Generic filers with tentative approvals for RITONAVIR
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing100MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing50MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing25MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for ritonavir
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
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma RITONAVIR ritonavir CAPSULE;ORAL 205801-001 Dec 3, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla RITONAVIR ritonavir TABLET;ORAL 202573-001 Jan 15, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd RITONAVIR ritonavir TABLET;ORAL 206614-001 Sep 17, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd Iii RITONAVIR ritonavir TABLET;ORAL 204587-001 Sep 17, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ritonavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 See Plans and Pricing See Plans and Pricing
Abbvie NORVIR ritonavir SOLUTION;ORAL 020659-001 Mar 1, 1996 See Plans and Pricing See Plans and Pricing
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 See Plans and Pricing See Plans and Pricing
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999 See Plans and Pricing See Plans and Pricing
Abbvie NORVIR ritonavir SOLUTION;ORAL 020659-001 Mar 1, 1996 See Plans and Pricing See Plans and Pricing
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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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