Isotretinoin Patent Expiration
Isotretinoin was first introduced by Hoffmann La Roche Inc
Isotretinoin Patents
Given below is the list of patents protecting Isotretinoin, 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 |
|---|---|---|---|---|
| Absorica Ld | US9700535 | Oral pharmaceutical composition of isotretinoin | Aug 04, 2035 | Sun Pharm |
| Absorica Ld | US9750711 | Low dose oral pharmaceutical composition of isotretinoin | May 29, 2035 | Sun Pharm |
| Absorica | US7435427 | Pharmaceutical semi-solid composition of isotretinoin |
Sep 21, 2021
(Expired) | Sun Pharm Inds Inc |
| Absorica | US8367102 | Pharmaceutical semi-solid composition of isotretinoin |
Sep 21, 2021
(Expired) | Sun Pharm Inds Inc |
| Absorica | US8952064 | Pharmaceutical semi-solid composition of isotretinoin |
Sep 21, 2021
(Expired) | Sun Pharm Inds Inc |
| Absorica | US9078925 | Pharmaceutical semi-solid composition of isotretinoin |
Sep 21, 2021
(Expired) | Sun Pharm Inds Inc |
| Absorica | US9089534 | Pharmaceutical semi-solid composition of isotretinoin |
Sep 21, 2021
(Expired) | Sun Pharm Inds Inc |
Isotretinoin's Family Patents
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Isotretinoin Generic API Manufacturers
Several generic applications have been filed for Isotretinoin. The first generic version for Isotretinoin was by Mylan Pharmaceuticals Inc and was approved on Nov 8, 2002. And the latest generic version is by Mylan Pharmaceuticals Inc and was approved on Mar 17, 2025.
Given below is the list of companies who have filed for Isotretinoin generic, along with the locations of their manufacturing plants worldwide.
1. ACTAVIS LABS FL
Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Isotretinoin. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB2 | Mar 31, 2021 |
| 35MG | capsule | Prescription | ORAL | AB2 | Mar 31, 2021 |
| 40MG | capsule | Prescription | ORAL | AB2 | Mar 31, 2021 |
| 10MG | capsule | Prescription | ORAL | AB2 | Mar 31, 2021 |
| 20MG | capsule | Prescription | ORAL | AB2 | Mar 31, 2021 |
| 30MG | capsule | Prescription | ORAL | AB2 | Mar 31, 2021 |
2. AMNEAL PHARMS NY
Amneal Pharmaceuticals Of Ny Llc has filed for 4 different strengths of generic version for Isotretinoin. Given below are the details of the strengths of this generic introduced by Amneal Pharms Ny.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | capsule | Prescription | ORAL | AB1 | Sep 29, 2017 |
| 10MG | capsule | Prescription | ORAL | AB1 | Sep 29, 2017 |
| 30MG | capsule | Prescription | ORAL | AB1 | Sep 29, 2017 |
| 40MG | capsule | Prescription | ORAL | AB1 | Sep 29, 2017 |
3. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 6 different strengths of generic version for Isotretinoin. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | capsule | Prescription | ORAL | AB2 | Jan 29, 2024 |
| 10MG | capsule | Prescription | ORAL | AB2 | Jan 29, 2024 |
| 20MG | capsule | Prescription | ORAL | AB2 | Jan 29, 2024 |
| 40MG | capsule | Prescription | ORAL | AB2 | Jan 29, 2024 |
| 30MG | capsule | Prescription | ORAL | AB2 | Jan 29, 2024 |
| 35MG | capsule | Prescription | ORAL | AB2 | Jan 29, 2024 |
Manufacturing Plant Locations New
Aurobindo Pharma'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 Aurobindo Pharma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||
| United States |
| |||||||||
4. DR REDDYS LABS LTD
Dr Reddys Laboratories Ltd has filed for 4 different strengths of generic version for Isotretinoin. All of these versions come by the name ZENATANE. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 40MG | capsule | Prescription | ORAL | AB1 | Mar 25, 2013 |
| 10MG | capsule | Prescription | ORAL | AB1 | Mar 25, 2013 |
| 20MG | capsule | Prescription | ORAL | AB1 | Mar 25, 2013 |
| 30MG | capsule | Prescription | ORAL | AB1 | Feb 23, 2015 |
5. MYLAN PHARMS INC
Mylan Pharmaceuticals Inc has filed for 4 different strengths of generic version for Isotretinoin. All of these versions come by the name AMNESTEEM. Given below are the details of the strengths of this generic introduced by Mylan Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule | Prescription | ORAL | AB1 | Nov 8, 2002 |
| 40MG | capsule | Prescription | ORAL | AB1 | Nov 8, 2002 |
| 20MG | capsule | Prescription | ORAL | AB1 | Nov 8, 2002 |
| 30MG | capsule | Prescription | ORAL | AB1 | Mar 17, 2025 |
6. SUN PHARM INDS LTD
Sun Pharmaceutical Industries Ltd has filed for 4 different strengths of generic version for Isotretinoin. All of these versions come by the name SOTRET. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | capsule | Discontinued | ORAL | N/A | Dec 24, 2002 |
| 40MG | capsule | Discontinued | ORAL | N/A | Dec 24, 2002 |
| 10MG | capsule | Discontinued | ORAL | N/A | Dec 24, 2002 |
| 30MG | capsule | Discontinued | ORAL | N/A | Jun 20, 2003 |
7. TEVA PHARMS USA
Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Isotretinoin. All of these versions come by the name CLARAVIS. 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 |
|---|---|---|---|---|---|
| 40MG
(reference standard) | capsule | Prescription | ORAL | AB1 | Apr 11, 2003 |
| 20MG | capsule | Prescription | ORAL | AB1 | Apr 11, 2003 |
| 10MG | capsule | Prescription | ORAL | AB1 | Apr 11, 2003 |
| 30MG | capsule | Prescription | ORAL | AB1 | May 11, 2006 |
8. UPSHER SMITH LABS
Upsher Smith Laboratories Llc has filed for 4 different strengths of generic version for Isotretinoin. Given below are the details of the strengths of this generic introduced by Upsher Smith Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 10MG | capsule | Prescription | ORAL | AB2 | Sep 21, 2021 |
| 40MG | capsule | Prescription | ORAL | AB2 | Apr 12, 2021 |
| 20MG | capsule | Prescription | ORAL | AB2 | Sep 21, 2021 |
| 30MG | capsule | Prescription | ORAL | AB2 | Sep 21, 2021 |
9. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Isotretinoin. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | capsule | Prescription | ORAL | AB1 | Aug 29, 2023 |
| 30MG | capsule | Prescription | ORAL | AB1 | Aug 29, 2023 |
| 40MG | capsule | Prescription | ORAL | AB1 | Aug 29, 2023 |
| 10MG | capsule | Prescription | ORAL | AB1 | Aug 29, 2023 |