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Last Updated: August 8, 2022

NORVIR Drug Patent 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.

The generic ingredient in NORVIR 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.

Paragraph IV (Patent) Challenges for NORVIR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NORVIR Tablets ritonavir 100 mg 022417 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie NORVIR ritonavir SOLUTION;ORAL 020659-001 Mar 1, 1996 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
Abbvie Inc NORVIR ritonavir POWDER;ORAL 209512-001 Jun 7, 2017 RX Yes Yes 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 NORVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999 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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for NORVIR

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

International Patents for NORVIR

See the table below for patents covering NORVIR around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2206500 Forme posologique pharmaceutique solide comprenant du lopinavir (A solid pharmaceutical dosage formulation comprising lopinavir) See Plans and Pricing
Denmark 0674513 See Plans and Pricing
Norway 20074807 See Plans and Pricing
Germany 10199053 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NORVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0674513 SPC/GB01/044 United Kingdom See Plans and Pricing 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 C300060 Netherlands See Plans and Pricing 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
0674513 C00674513 Switzerland See Plans and Pricing PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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