Dapsone Patent Expiration
Dapsone is used for treating acne vulgaris through topical application. It was first introduced by Abbvie Inc
Dapsone Patents
Given below is the list of patents protecting Dapsone, 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 |
|---|---|---|---|---|
| Aczone | US11273132 | Topical dapsone and dapsone/adapalene compositions and methods for use thereof | Nov 18, 2033 | Almirall |
| Aczone | US5863560 | Compositions and methods for topical application of therapeutic agents |
Sep 11, 2016
(Expired) | Abbvie |
| Aczone | US5863560 | Compositions and methods for topical application of therapeutic agents |
Sep 11, 2016
(Expired) | Almirall |
| Aczone | US6060085 | Compositions and methods for topical application of therapeutic agents |
Sep 11, 2016
(Expired) | Abbvie |
| Aczone | US6060085 | Compositions and methods for topical application of therapeutic agents |
Sep 11, 2016
(Expired) | Almirall |
| Aczone | US6620435 | Compositions for topical application of therapeutic agents |
Sep 11, 2016
(Expired) | Abbvie |
| Aczone | US6620435 | Compositions for topical application of therapeutic agents |
Sep 11, 2016
(Expired) | Almirall |
| Aczone | US9161926 | Topical dapsone and dapsone/adaplene compositions and methods for use thereof | Nov 18, 2033 | Almirall |
| Aczone | US9517219 | Topical dapsone and dapsone/adapalene compositions and methods for use thereof | Nov 18, 2033 | Almirall |
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Dapsone Generics
Several generic applications have been filed for Dapsone. The first generic version for Dapsone was by Everest Life Sciences Llc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Zydus Lifesciences Global Fze and was approved on May 8, 2024.
Given below is the list of companies who have filed for Dapsone generic.
1. TORRENT
Torrent Pharmaceuticals Ltd has filed for 1 generic for Dapsone. Given below are the details of the strengths of this generic introduced by Torrent.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 7.5% | gel | Prescription | TOPICAL | AB | Feb 10, 2022 |
2. TARO
Taro Pharmaceuticals Inc has filed for 4 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Taro.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5% | gel | Prescription | TOPICAL | AB | Oct 16, 2017 |
| 25MG | tablet | Discontinued | ORAL | N/A | Mar 1, 2019 |
| 100MG | tablet | Discontinued | ORAL | N/A | Mar 1, 2019 |
| 7.5% | gel | Prescription | TOPICAL | AB | Jun 26, 2019 |
3. MYLAN
Mylan Pharmaceuticals Inc has filed for 1 generic for Dapsone. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 7.5% | gel | Prescription | TOPICAL | AB | Feb 4, 2022 |
4. ENCUBE
Encube Ethicals Private Ltd has filed for 1 generic for Dapsone. Given below are the details of the strengths of this generic introduced by Encube.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5% | gel | Prescription | TOPICAL | AB | Oct 13, 2023 |
5. AMNEAL
Amneal Pharmaceuticals Llc has filed for 2 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 7.5% | gel | Prescription | TOPICAL | AB | May 31, 2023 |
| 5% | gel | Prescription | TOPICAL | AB | Oct 19, 2023 |
6. NOSTRUM LABS INC
Nostrum Laboratories Inc has filed for 2 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Nostrum Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | tablet | Prescription | ORAL | AB | May 6, 2016 |
| 100MG | tablet | Prescription | ORAL | AB | May 6, 2016 |
7. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Chartwell Rx.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | tablet | Discontinued | ORAL | N/A | May 10, 2016 |
| 100MG | tablet | Discontinued | ORAL | N/A | May 10, 2016 |
8. ACTAVIS LLC
Actavis Llc has filed for 2 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Actavis Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | tablet | Prescription | ORAL | AB | Mar 23, 2017 |
| 25MG | tablet | Prescription | ORAL | AB | Mar 23, 2017 |
9. RISING
Rising Pharma Holdings Inc has filed for 2 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | tablet | Prescription | ORAL | AB | May 8, 2019 |
| 25MG | tablet | Prescription | ORAL | AB | Jul 20, 2023 |
10. COSETTE
Cosette Pharmaceuticals Inc has filed for 1 generic for Dapsone. Given below are the details of the strengths of this generic introduced by Cosette.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5% | gel | Prescription | TOPICAL | AB | Mar 31, 2022 |
11. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Padagis Israel.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5% | gel | Discontinued | TOPICAL | N/A | Oct 31, 2023 |
| 7.5% | gel | Discontinued | TOPICAL | N/A | Nov 1, 2023 |
12. ALVOGEN
Alvogen Inc has filed for 2 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Alvogen.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | tablet | Discontinued | ORAL | N/A | Jan 7, 2016 |
| 100MG | tablet | Discontinued | ORAL | N/A | Jan 7, 2016 |
13. EVEREST LIFE SCI
Everest Life Sciences Llc has filed for 2 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Everest Life Sci.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG
(reference listed drug) | tablet | Prescription | ORAL | AB | Approved Prior to Jan 1, 1982 |
| 100MG
(reference listed drug) | tablet | Prescription | ORAL | AB | Approved Prior to Jan 1, 1982 |
14. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 1 generic for Dapsone. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 7.5% | gel | Prescription | TOPICAL | AB | Oct 27, 2023 |
15. ZYDUS LIFESCIENCES
Zydus Lifesciences Global Fze has filed for 1 generic for Dapsone. 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 |
|---|---|---|---|---|---|
| 7.5% | gel | Prescription | TOPICAL | AB | May 8, 2024 |
16. NOVITIUM PHARMA
Novitium Pharma Llc has filed for 2 different strengths of generic version for Dapsone. Given below are the details of the strengths of this generic introduced by Novitium Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MG | tablet | Prescription | ORAL | AB | Dec 1, 2016 |
| 100MG
(reference standard) | tablet | Prescription | ORAL | AB | Dec 1, 2016 |
17. BELOTECA
Beloteca Inc has filed for 1 generic for Dapsone. Given below are the details of the strengths of this generic introduced by Beloteca.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5% | gel | Prescription | TOPICAL | AB | Jun 6, 2023 |