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Last Updated: July 12, 2020

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NORVIR Drug Profile


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When do Norvir patents expire, and when can generic versions of Norvir launch?

Norvir is a drug marketed by Abbott, Abbvie, and Abbvie Inc. and is included in five NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in NORVIR is ritonavir. There are twenty-one drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ritonavir profile page.

US ANDA Litigation and Generic Entry Outlook for Norvir

A generic version of NORVIR was approved as ritonavir by HIKMA on January 15th, 2015.

  Start Trial

Paragraph IV (Patent) Challenges for NORVIR
Tradename Dosage Ingredient NDA Submissiondate
NORVIR TABLET;ORAL ritonavir 022417 2010-12-21

US Patents and Regulatory Information for NORVIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott NORVIR ritonavir CAPSULE;ORAL 020680-001 Mar 1, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Abbvie Inc NORVIR ritonavir POWDER;ORAL 209512-001 Jun 7, 2017 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
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 AB RX Yes Yes   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 NORVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999   Start Trial   Start Trial
Abbott NORVIR ritonavir CAPSULE;ORAL 020680-001 Mar 1, 1996   Start Trial   Start Trial
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010   Start Trial   Start Trial
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999   Start Trial   Start Trial
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NORVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0674513 SPC/GB01/044 United Kingdom   Start Trial PRODUCT NAME: THE COMBINATION OF THE ACTIVE INGREDIENTS RITONAVIR AND LOPINAVIR; REGISTERED: CH 55649 20001213; UK EU/1/01/172/001 20010320; UK EU/1/01/172/002 20010320; UK EU/1/01/172/003 20010320
0674513 C00674513 Switzerland   Start Trial PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
0674513 C300060 Netherlands   Start Trial PRODUCT NAME: RITONAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN FARMACEUTISCH AANVAARDBARE ESTER, EN LOPINAVIR; REGISTRATION NO/DATE: EU/1/01/172/001 - EU/1/01/172/003 20010320
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Dow
Johnson and Johnson
AstraZeneca
Mallinckrodt

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