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Last Updated: August 14, 2020

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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, Abbvie Inc, Amneal Pharms Llc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, and Hikma, and is included in nine NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for ritonavir. Nine suppliers are listed for this compound. There are three 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
Obafemi Awolowo UniversityPhase 2
African Centre of Excellence for Genomics of Infectious DiseasesPhase 2
Oyo State Ministry of HealthPhase 2

See all ritonavir clinical trials

Generic filers with tentative approvals for RITONAVIR
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MGTABLET;ORAL
  Start Trial  Start Trial100MGTABLET;ORAL
  Start Trial  Start Trial50MGTABLET; 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 NDA Submissiondate
NORVIR TABLET;ORAL ritonavir 022417 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 SOLUTION;ORAL 020659-001 Mar 1, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Hikma RITONAVIR ritonavir TABLET;ORAL 202573-001 Jan 15, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Amneal Pharms Llc RITONAVIR ritonavir TABLET;ORAL 208890-001 Sep 17, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii RITONAVIR ritonavir TABLET;ORAL 204587-001 Sep 17, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
>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 SOLUTION;ORAL 020659-001 Mar 1, 1996   Start Trial   Start Trial
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999   Start Trial   Start Trial
Abbvie NORVIR ritonavir SOLUTION;ORAL 020659-001 Mar 1, 1996   Start Trial   Start Trial
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010   Start Trial   Start Trial
Abbvie NORVIR ritonavir SOLUTION;ORAL 020659-001 Mar 1, 1996   Start Trial   Start Trial
Abbott NORVIR ritonavir CAPSULE;ORAL 020680-001 Mar 1, 1996   Start Trial   Start Trial
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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