Desonide - Generic Drug Details
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What are the generic sources for desonide and what is the scope of freedom to operate?
Desonide
is the generic ingredient in four branded drugs marketed by Almirall, Alembic, Cadila, Cosette, Glenmark Pharms, Padagis Us, Taro, Galderma Labs Lp, Leo Pharma As, Cintex Svcs, Fougera Pharms, Pai Holdings Pharm, Encube Ethicals, Glenmark Pharms Ltd, and Hikma, and is included in twenty-five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Desonide has twenty-two patent family members in sixteen countries.
There are thirty-one drug master file entries for desonide. Eighteen suppliers are listed for this compound.
Summary for desonide
International Patents: | 22 |
US Patents: | 3 |
Tradenames: | 4 |
Applicants: | 15 |
NDAs: | 25 |
Drug Master File Entries: | 31 |
Finished Product Suppliers / Packagers: | 18 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 8 |
Patent Applications: | 6,966 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for desonide |
Drug Sales Revenues: | Drug sales revenues for desonide |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for desonide |
What excipients (inactive ingredients) are in desonide? | desonide excipients list |
DailyMed Link: | desonide at DailyMed |
Recent Clinical Trials for desonide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Procter and Gamble | Phase 3 |
EMS | Phase 4 |
NeoStrata Company, Inc. | Phase 3 |
Pharmacology for desonide
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for desonide
US Patents and Regulatory Information for desonide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fougera Pharms | DESONIDE | desonide | LOTION;TOPICAL | 075860-001 | Mar 19, 2002 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Alembic | DESONIDE | desonide | OINTMENT;TOPICAL | 212473-001 | Oct 23, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Galderma Labs Lp | DESOWEN | desonide | OINTMENT;TOPICAL | 071425-001 | Jun 15, 1988 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Leo Pharma As | DESONATE | desonide | GEL;TOPICAL | 021844-001 | Oct 20, 2006 | DISCN | Yes | 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 |
Expired US Patents for desonide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Almirall | VERDESO | desonide | AEROSOL, FOAM;TOPICAL | 021978-001 | Sep 19, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Almirall | VERDESO | desonide | AEROSOL, FOAM;TOPICAL | 021978-001 | Sep 19, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Leo Pharma As | DESONATE | desonide | GEL;TOPICAL | 021844-001 | Oct 20, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for desonide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 181632 | תכשירים ותהליך להכנת מיקרואמולסיה ואמולסיה תת-מיקרונים (Microemulsion and sub-micron emulsion process and compositions) | ⤷ Try a Trial |
Russian Federation | 2381023 | СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ (METHOD FOR MAKING MICROEMULSIONS AND SUBMICRON EMULSIONS AND BASED COMPOSITION) | ⤷ Try a Trial |
European Patent Office | 1796636 | PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS) | ⤷ Try a Trial |
China | 101048136 | Microemulsion and sub-micron emulsion process and compositions | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for desonide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0613371 | SPC/GB02/033 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515 |
2435024 | SPC/GB21/029 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210 |
2435024 | 21C1020 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
2435024 | 2021C/518 | Belgium | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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