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DESONATE Drug Profile
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» See Plans and PricingWhen do Desonate patents expire, and what generic alternatives are available?
Desonate is a drug marketed by Leo Pharma As and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has thirty-four patent family members in twenty-two countries.
The generic ingredient in DESONATE is desonide. There are thirty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the desonide profile page.
US ANDA Litigation and Generic Entry Outlook for Desonate
A generic version of DESONATE was approved as desonide by TARO on August 3rd, 1994.
Summary for DESONATE
| International Patents: | 34 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,905 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DESONATE |
| Drug Sales Revenues: | Drug sales revenues for DESONATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DESONATE |
| DailyMed Link: | DESONATE at DailyMed |
Recent Clinical Trials for DESONATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University | Phase 4 |
Pharmacology for DESONATE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for DESONATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Leo Pharma As | DESONATE | desonide | GEL;TOPICAL | 021844-001 | Oct 20, 2006 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for DESONATE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | 429922 | Start Trial |
| Russian Federation | 2251410 | Start Trial |
| Slovenia | 1304992 | Start Trial |
| Brazil | 0113247 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DESONATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | C300617 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322 |
| 1304992 | 92401 | Luxembourg | Start Trial | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
| 1304992 | 132013902214376 | Italy | Start Trial | PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718 |
| 0613371 | SPC/GB02/033 | United Kingdom | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
