Norvir Patent Expiration

Norvir is a drug owned by Abbvie Inc. It is protected by 34 US drug patents filed from 2013 to 2014. Out of these, 5 drug patents are active and 29 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 17, 2027. Details of Norvir's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8470347

(Pediatric)

Self-emulsifying active substance formulation and use of this formulation
Mar, 2027

(2 years from now)

Active
US8470347 Self-emulsifying active substance formulation and use of this formulation
Sep, 2026

(1 year, 9 months from now)

Active
US8399015

(Pediatric)

Solid pharmaceutical dosage form
Feb, 2025

(2 months from now)

Active
US8268349

(Pediatric)

Solid pharmaceutical dosage form
Feb, 2025

(2 months from now)

Active
US8691878

(Pediatric)

Solid pharmaceutical dosage form
Feb, 2025

(2 months from now)

Active
US8399015 Solid pharmaceutical dosage form
Aug, 2024

(3 months ago)

Expired
US8268349 Solid pharmaceutical dosage form
Aug, 2024

(3 months ago)

Expired
US8691878 Solid pharmaceutical dosage form
Aug, 2024

(3 months ago)

Expired
US7364752

(Pediatric)

Solid dispersion pharamaceutical formulations
May, 2021

(3 years ago)

Expired
US7141593

(Pediatric)

Pharmaceutical formulations
Nov, 2020

(4 years ago)

Expired
US7432294

(Pediatric)

Pharmaceutical formulations
Nov, 2020

(4 years ago)

Expired
US7364752 Solid dispersion pharamaceutical formulations
Nov, 2020

(4 years ago)

Expired
US7432294 Pharmaceutical formulations
May, 2020

(4 years ago)

Expired
US7141593 Pharmaceutical formulations
May, 2020

(4 years ago)

Expired
US7148359

(Pediatric)

Polymorph of a pharmaceutical
Jan, 2020

(4 years ago)

Expired
US7148359 Polymorph of a pharmaceutical
Jul, 2019

(5 years ago)

Expired
US6232333

(Pediatric)

Pharmaceutical composition
May, 2018

(6 years ago)

Expired
US6232333 Pharmaceutical composition
Nov, 2017

(7 years ago)

Expired
US6037157

(Pediatric)

Method for improving pharmacokinetics
Dec, 2016

(7 years ago)

Expired
US6703403

(Pediatric)

Method for improving pharmacokinetics
Dec, 2016

(7 years ago)

Expired
US6037157 Method for improving pharmacokinetics
Jun, 2016

(8 years ago)

Expired
US6703403 Method for improving pharmacokinetics
Jun, 2016

(8 years ago)

Expired
US5648497

(Pediatric)

Retroviral protease inhibiting compounds
Jan, 2015

(9 years ago)

Expired
US5484801

(Pediatric)

Pharmaceutical composition for inhibiting HIV protease
Jul, 2014

(10 years ago)

Expired
US5648497 Retroviral protease inhibiting compounds
Jul, 2014

(10 years ago)

Expired
US5948436

(Pediatric)

Pharmaceutical composition
Mar, 2014

(10 years ago)

Expired
US5635523

(Pediatric)

Retroviral protease inhibiting compounds
Jan, 2014

(10 years ago)

Expired
US5674882

(Pediatric)

Retroviral protease inhibiting compounds
Jan, 2014

(10 years ago)

Expired
US5541206

(Pediatric)

Retroviral protease inhibiting compounds
Jan, 2014

(10 years ago)

Expired
US5484801 Pharmaceutical composition for inhibiting HIV protease
Jan, 2014

(10 years ago)

Expired
US5948436 Pharmaceutical composition
Sep, 2013

(11 years ago)

Expired
US5674882 Retroviral protease inhibiting compounds
Jul, 2013

(11 years ago)

Expired
US5635523 Retroviral protease inhibiting compounds
Jul, 2013

(11 years ago)

Expired
US5541206 Retroviral protease inhibiting compounds
Jul, 2013

(11 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Norvir's patents.

Given below is the list of recent legal activities going on the following patents of Norvir.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 06 May, 2024 US8268349
Expire Patent 02 Aug, 2021 US8470347 (Litigated)
Expire Patent 26 Apr, 2021 US8399015
Maintenance Fee Reminder Mailed 15 Feb, 2021 US8470347 (Litigated)
Maintenance Fee Reminder Mailed 09 Nov, 2020 US8399015
Payment of Maintenance Fee, 12th Year, Large Entity 16 Mar, 2020 US7432294
Payment of Maintenance Fee, 8th Year, Large Entity 18 Feb, 2020 US8268349
Payment of Maintenance Fee, 12th Year, Large Entity 09 May, 2018 US7148359
Mail O.P. Petition Decision 12 Feb, 2015 US8470347 (Litigated)
Mail-Petition Decision - Dismissed 10 Feb, 2015 US8470347 (Litigated)


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Norvir and ongoing litigations to help you estimate the early arrival of Norvir generic.

Norvir's Litigations

Norvir been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 17, 2009, against patent number US8470347. The petitioner , challenged the validity of this patent, with Gunther Berndl et al as the respondent. Click below to track the latest information on how companies are challenging Norvir's patents.

Last updated on December 3, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8470347 August, 2009 Decision
(27 May, 2010)
Gunther Berndl et al


FDA has granted some exclusivities to Norvir. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Norvir, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Norvir.

Exclusivity Information

Norvir holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Norvir's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-184) Jun 07, 2024

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Norvir is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Norvir's family patents as well as insights into ongoing legal events on those patents.

Norvir's Family Patents

Norvir has patent protection in a total of 37 countries. It's US patent count contributes only to 18.1% of its total global patent coverage. 14 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Norvir.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Norvir's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 17, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Norvir Generic API suppliers:

Ritonavir is the generic name for the brand Norvir. 6 different companies have already filed for the generic of Norvir, with Cipla having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Norvir's generic

How can I launch a generic of Norvir before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Norvir's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Norvir's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Norvir -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
100 mg 21 Dec, 2010 1 15 Jan, 2015 10 May, 2021 Eligible

Alternative Brands for Norvir

Norvir which is used for treating HIV infection in combination with other antiretroviral agents., has several other brand drugs in the same treatment category and using the same active ingredient (Ritonavir). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Abbvie
Kaletra

(uses Ritonavir)

used for treating HIV-1 infection in combination with other antiretroviral agents.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Ritonavir. Given below is the list of those drugs and companies owning them.



Apart from brand drugs containing the same ingredient, some generics have also been filed for Ritonavir, Norvir's active ingredient. Check the complete list of approved generic manufacturers for Norvir





About Norvir

Norvir is a drug owned by Abbvie Inc. It is used for treating HIV infection in combination with other antiretroviral agents. Norvir uses Ritonavir as an active ingredient. Norvir was launched by Abbvie in 2010.

Approval Date:

Norvir was approved by FDA for market use on 10 February, 2010.

Active Ingredient:

Norvir uses Ritonavir as the active ingredient. Check out other Drugs and Companies using Ritonavir ingredient

Treatment:

Norvir is used for treating HIV infection in combination with other antiretroviral agents.

Dosage:

Norvir is available in the following dosage forms - solution form for oral use, tablet form for oral use, capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
100MG TABLET Prescription ORAL
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE Discontinued ORAL
80MG/ML SOLUTION Discontinued ORAL


Norvir Patent Expiration

Norvir is a drug owned by Abbott Laboratories Pharmaceutical Products Div. It is protected by 8 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 07, 2024. Details of Norvir's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5648497

(Pediatric)

Retroviral protease inhibiting compounds
Jan, 2015

(9 years ago)

Expired
US5635523

(Pediatric)

Retroviral protease inhibiting compounds
Dec, 2014

(10 years ago)

Expired
US5648497 Retroviral protease inhibiting compounds
Jul, 2014

(10 years ago)

Expired
US5635523 Retroviral protease inhibiting compounds
Jun, 2014

(10 years ago)

Expired
US5948436

(Pediatric)

Pharmaceutical composition
Mar, 2014

(10 years ago)

Expired
US5541206

(Pediatric)

Retroviral protease inhibiting compounds
Jan, 2014

(10 years ago)

Expired
US5948436 Pharmaceutical composition
Sep, 2013

(11 years ago)

Expired
US5541206 Retroviral protease inhibiting compounds
Jul, 2013

(11 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Norvir's patents.

Given below is the list of recent legal activities going on the following patents of Norvir.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 06 May, 2024 US8268349
Expire Patent 02 Aug, 2021 US8470347 (Litigated)
Expire Patent 26 Apr, 2021 US8399015
Maintenance Fee Reminder Mailed 15 Feb, 2021 US8470347 (Litigated)
Maintenance Fee Reminder Mailed 09 Nov, 2020 US8399015
Payment of Maintenance Fee, 12th Year, Large Entity 16 Mar, 2020 US7432294
Payment of Maintenance Fee, 8th Year, Large Entity 18 Feb, 2020 US8268349
Payment of Maintenance Fee, 12th Year, Large Entity 09 May, 2018 US7148359
Mail O.P. Petition Decision 12 Feb, 2015 US8470347 (Litigated)
Mail-Petition Decision - Dismissed 10 Feb, 2015 US8470347 (Litigated)


FDA has granted several exclusivities to Norvir. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Norvir, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Norvir.

Exclusivity Information

Norvir holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Norvir's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-184) Jun 07, 2024

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Norvir is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Norvir's family patents as well as insights into ongoing legal events on those patents.

Norvir's Family Patents


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Norvir's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 07, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Norvir Generic API suppliers:

Ritonavir is the generic name for the brand Norvir. 6 different companies have already filed for the generic of Norvir, with Cipla having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Norvir's generic

How can I launch a generic of Norvir before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Norvir's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Norvir's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Norvir -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
100 mg 21 Dec, 2010 1 15 Jan, 2015 10 May, 2021 Eligible

Alternative Brands for Norvir

Norvir which is used for treating HIV infection in combination with other antiretroviral agents., has several other brand drugs in the same treatment category and using the same active ingredient (Ritonavir). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Abbvie
Kaletra

(uses Ritonavir)

used for treating HIV-1 infection in combination with other antiretroviral agents.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Ritonavir. Given below is the list of those drugs and companies owning them.



Apart from brand drugs containing the same ingredient, some generics have also been filed for Ritonavir, Norvir's active ingredient. Check the complete list of approved generic manufacturers for Norvir





About Norvir

Norvir is a drug owned by Abbott Laboratories Pharmaceutical Products Div. It is used for treating HIV infection in combination with other antiretroviral agents. Norvir uses Ritonavir as an active ingredient. Norvir was launched by Abbott in 1996.

Approval Date:

Norvir was approved by FDA for market use on 01 March, 1996.

Active Ingredient:

Norvir uses Ritonavir as the active ingredient. Check out other Drugs and Companies using Ritonavir ingredient

Treatment:

Norvir is used for treating HIV infection in combination with other antiretroviral agents.

Dosage:

Norvir is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
100MG CAPSULE Discontinued ORAL