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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. 20 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 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
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



Dapsone's Family Patents

Family Patents

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Dapsone Generic API Manufacturers

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 Aurobindo Pharma Ltd and was approved on Apr 4, 2025.

Given below is the list of companies who have filed for Dapsone generic, along with the locations of their manufacturing plants worldwide.


1. 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
25MG

tablet Prescription ORAL AB Mar 23, 2017
100MG

tablet Prescription ORAL AB Mar 23, 2017


Manufacturing Plant Locations
New

Actavis Llc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Llc as present at those locations.

Country City Firm Name
United States
Edison Actavis LLC





2. 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


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)





3. 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
100MG

tablet Discontinued ORAL N/A Jan 7, 2016
25MG

tablet Discontinued ORAL N/A Jan 7, 2016


Manufacturing Plant Locations
New

Alvogen's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Alvogen as present at those locations.

Country City Firm Name
United States
Morristown Alvogen, Inc





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


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
Branchburg Amneal Pharmaceuticals, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Paterson Amneal Pharmaceuticals, Llc
Brookhaven Amneal Pharmaceuticals of New York, LLC
East Hanover Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
Bridgewater Amneal Complex Products Research LLC
Glasgow Amneal Pharmaceuticals LLC
India
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.





5. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Dapsone. 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
5%

gel Prescription TOPICAL AB Apr 4, 2025


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
Medchal Aurobindo Pharma Ltd





6. 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





7. 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


Manufacturing Plant Locations
New

Cosette's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Cosette as present at those locations.

Country City Firm Name
United States
Lincolnton Cosette Pharmaceuticals NC Laboratories, LLC
South Plainfield Cosette Pharmaceuticals, Inc.





8. 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


Manufacturing Plant Locations
New

Encube'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 Encube as present at those locations.

Country City Firm Name
India
Ponda Encube Ethicals Pvt. Ltd.
Andheri East, Mumbai Encube Ethicals Private Ltd





9. 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

tablet Prescription ORAL AB Approved Prior to Jan 1, 1982
100MG

tablet Prescription ORAL AB Approved Prior to Jan 1, 1982


Manufacturing Plant Locations
New

Everest Life Sci's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Everest Life Sci as present at those locations.

Country City Firm Name
United States
Plainsboro Everest Life Sciences LLC





10. 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


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Morgantown Mylan Specialty, L.P.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Saint Albans Mylan Technologies, Inc.
Greensboro Mylan Pharmaceuticals Inc
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Rockford Mylan Institutional, Inc.
India
Sarigam Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Anekal Taluk, Bangalore Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





11. 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


Manufacturing Plant Locations
New

Novitium Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Novitium Pharma as present at those locations.

Country City Firm Name
United States
East Windsor Novitium Pharma LLC





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


Manufacturing Plant Locations
New

Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.

Country City Firm Name
Israel
Yerucham Padagis Israel Pharmaceuticals Ltd.





13. 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


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Livingston Risingsun Iodine Products Corp.
East Brunswick Rising Pharma Holding, Inc.
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Mount Morris Rising Creek Bakery LLC
Phoenix Rising Sun Farms Inc
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
Fort Bragg Rising Tide Sea Vegetables
Rising Sun Rising Sun Veterinary Clinic
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





14. SOLIS PHARMS

Solis Pharmaceuticals 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 Solis Pharms.

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





15. 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


Manufacturing Plant Locations
New

Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country City Firm Name
United States
Honolulu Taro Delight, LLC
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





16. 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


Manufacturing Plant Locations
New

Torrent'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 Torrent as present at those locations.

Country City Firm Name
India
Pithampur Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
Bharuch Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
United States
Basking Ridge Torrent Pharma Inc.
Kalamazoo Torrent Pharma Inc.





17. TRUPHARMA

Trupharma 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 Trupharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

gel Prescription TOPICAL AB Jun 6, 2023
7.5%

gel Prescription TOPICAL AB Aug 26, 2024





18. 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


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
Matoda Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited
Ankleshwar Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited
District Solan Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED