Darunavir Patent Expiration
Darunavir is Used for treating HIV infection in both adult and pediatric patients. It was first introduced by Janssen Products Lp
Darunavir Patents
Given below is the list of patents protecting Darunavir, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Prezista |
US7700645 (Pediatric) | Pseudopolymorphic forms of a HIV protease inhibitor | Jun 26, 2027 | Janssen Prods |
| Prezista | US7700645 | Pseudopolymorphic forms of a HIV protease inhibitor | Dec 26, 2026 | Janssen Prods |
| Prezista |
US8518987 (Pediatric) | Pseudopolymorphic forms of a HIV protease inhibitor |
Aug 16, 2024
(Expired) | Janssen Prods |
| Prezista | US8518987 | Pseudopolymorphic forms of a HIV protease inhibitor |
Feb 16, 2024
(Expired) | Janssen Prods |
| Prezista |
US7470506 (Pediatric) | Fitness assay and associated methods |
Dec 23, 2019
(Expired) | Janssen Prods |
| Prezista |
US8597876 (Pediatric) | Method of treating HIV infection |
Dec 23, 2019
(Expired) | Janssen Prods |
| Prezista |
US9889115 (Pediatric) | Fitness assay and associated methods |
Dec 23, 2019
(Expired) | Janssen Prods |
| Prezista | US7470506 | Fitness assay and associated methods |
Jun 23, 2019
(Expired) | Janssen Prods |
| Prezista | US8597876 | Method of treating HIV infection |
Jun 23, 2019
(Expired) | Janssen Prods |
| Prezista | US9889115 | Fitness assay and associated methods |
Jun 23, 2019
(Expired) | Janssen Prods |
| Prezista |
USRE43596 (Pediatric) | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Nov 09, 2017
(Expired) | Janssen Prods |
| Prezista | USRE43596 | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
May 09, 2017
(Expired) | Janssen Prods |
| Prezista |
USRE42889 (Pediatric) | α- and β- amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Apr 19, 2017
(Expired) | Janssen Prods |
| Prezista |
USRE43802 (Pediatric) | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Apr 19, 2017
(Expired) | Janssen Prods |
| Prezista |
US6037157 (Pediatric) | Method for improving pharmacokinetics |
Dec 26, 2016
(Expired) | Janssen Prods |
| Prezista |
US6703403 (Pediatric) | Method for improving pharmacokinetics |
Dec 26, 2016
(Expired) | Janssen Prods |
| Prezista | USRE42889 | α- and β- amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Oct 19, 2016
(Expired) | Janssen Prods |
| Prezista | USRE43802 | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Oct 19, 2016
(Expired) | Janssen Prods |
| Prezista | US6037157 | Method for improving pharmacokinetics |
Jun 26, 2016
(Expired) | Janssen Prods |
| Prezista | US6703403 | Method for improving pharmacokinetics |
Jun 26, 2016
(Expired) | Janssen Prods |
| Prezista |
US5843946 (Pediatric) | α-and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Jun 01, 2016
(Expired) | Janssen Prods |
| Prezista | US5843946 | α-and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Dec 01, 2015
(Expired) | Janssen Prods |
| Prezista |
US6248775 (Pediatric) | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Feb 13, 2015
(Expired) | Janssen Prods |
| Prezista | US6248775 | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Aug 13, 2014
(Expired) | Janssen Prods |
| Prezista |
US6335460 (Pediatric) | α-and β-amino acid hydroxyethlamino sulfonamides useful as retroviral protease inhibitors |
Feb 25, 2013
(Expired) | Janssen Prods |
| Prezista | US6335460 | α-and β-amino acid hydroxyethlamino sulfonamides useful as retroviral protease inhibitors |
Aug 25, 2012
(Expired) | Janssen Prods |
Darunavir's Family Patents
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Darunavir Generic API Manufacturers
Several generic applications have been filed for Darunavir. The first generic version for Darunavir was by Teva Pharmaceuticals Usa Inc and was approved on Nov 21, 2017. And the latest generic version is by Annora Pharma Private Ltd and was approved on Jan 21, 2025.
Given below is the list of companies who have filed for Darunavir generic, along with the locations of their manufacturing plants worldwide.
1. AMNEAL
Amneal Eu Ltd has filed for 2 different strengths of generic version for Darunavir. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Dec 8, 2023 |
| 800MG | tablet | Prescription | ORAL | AB | Dec 8, 2023 |
Manufacturing Plant Locations New
Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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2. ANNORA PHARMA
Annora Pharma Private Ltd has filed for 2 different strengths of generic version for Darunavir. Given below are the details of the strengths of this generic introduced by Annora Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Jan 21, 2025 |
| 800MG | tablet | Prescription | ORAL | AB | Jan 21, 2025 |
Manufacturing Plant Locations New
Annora Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Annora Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
3. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Darunavir. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Nov 28, 2023 |
| 800MG | tablet | Prescription | ORAL | AB | Nov 28, 2023 |
Manufacturing Plant Locations New
Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
4. CIPLA
Cipla Ltd has filed for 2 different strengths of generic version for Darunavir. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 800MG | tablet | Prescription | ORAL | AB | Nov 28, 2023 |
| 600MG | tablet | Prescription | ORAL | AB | Nov 28, 2023 |
Manufacturing Plant Locations New
Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||
5. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Darunavir. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Nov 28, 2023 |
| 800MG | tablet | Prescription | ORAL | AB | Nov 28, 2023 |
6. HETERO LABS LTD III
Hetero Labs Ltd Unit Iii has filed for 2 different strengths of generic version for Darunavir. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 400MG | tablet | Prescription | ORAL | N/A | Sep 14, 2023 |
| 600MG | tablet | Prescription | ORAL | AB | Sep 14, 2023 |
7. LUPIN LTD
Lupin Ltd has filed for 2 different strengths of generic version for Darunavir. Given below are the details of the strengths of this generic introduced by Lupin Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Sep 29, 2022 |
| 800MG | tablet | Prescription | ORAL | AB | Sep 29, 2022 |
Manufacturing Plant Locations New
Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
8. MSN
Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Darunavir. Given below are the details of the strengths of this generic introduced by Msn.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Nov 28, 2023 |
| 800MG | tablet | Prescription | ORAL | AB | Nov 28, 2023 |
Manufacturing Plant Locations New
Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||||||||
| United States |
| |||||||||||||||||||||
9. TEVA PHARMS USA
Teva Pharmaceuticals Usa Inc has filed for 1 generic for Darunavir. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Nov 21, 2017 |
10. ZYDUS LIFESCIENCES
Zydus Lifesciences Ltd has filed for 2 different strengths of generic version for Darunavir. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 600MG | tablet | Prescription | ORAL | AB | Dec 13, 2023 |
| 800MG | tablet | Prescription | ORAL | AB | Dec 13, 2023 |
Manufacturing Plant Locations New
Zydus Lifesciences's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Zydus Lifesciences as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||||||