DAPSONE Drug Patent Profile
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Which patents cover Dapsone, and what generic alternatives are available?
Dapsone is a drug marketed by Alembic, Amneal, Beloteca, Cosette, Encube, Mylan, Padagis Israel, Taro, Torrent, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Nostrum Labs Inc, Novitium Pharma, and Rising. and is included in twenty-one NDAs.
The generic ingredient in DAPSONE is dapsone. There are eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the dapsone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dapsone
A generic version of DAPSONE was approved as dapsone by NOSTRUM LABS INC on May 6th, 2016.
Summary for DAPSONE
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 151 |
| Clinical Trials: | 87 |
| Patent Applications: | 3,931 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DAPSONE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DAPSONE |
| What excipients (inactive ingredients) are in DAPSONE? | DAPSONE excipients list |
| DailyMed Link: | DAPSONE at DailyMed |
Recent Clinical Trials for DAPSONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assiut University | Phase 4 |
| Pulmonem Inc. | Phase 3 |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 3 |
Pharmacology for DAPSONE
| Drug Class | Sulfone |
Medical Subject Heading (MeSH) Categories for DAPSONE
Anatomical Therapeutic Chemical (ATC) Classes for DAPSONE
US Patents and Regulatory Information for DAPSONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taro | DAPSONE | dapsone | TABLET;ORAL | 209430-002 | Mar 1, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alembic | DAPSONE | dapsone | GEL;TOPICAL | 215718-001 | Oct 27, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell Rx | DAPSONE | dapsone | TABLET;ORAL | 204074-002 | May 10, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novitium Pharma | DAPSONE | dapsone | TABLET;ORAL | 206505-002 | Dec 1, 2016 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan | DAPSONE | dapsone | GEL;TOPICAL | 213847-001 | Feb 4, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
