Dapsone Patent Expiration

Dapsone is used for treating acne vulgaris through topical application. It was first introduced by Abbvie Inc in its drug Aczone on Jul 7, 2005. 19 different companies have introduced drugs containing Dapsone.


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. 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


2. 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


3. 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


4. 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


5. 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


6. 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


7. 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


8. 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


9. 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


10. 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


11. 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


12. 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


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. 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


15. 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


16. 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


17. 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