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DESONATE Drug Profile
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When do Desonate patents expire, and when can generic versions of Desonate launch?
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 January 26th, 2020.
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: | 4,980 |
| 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 |
Recent Litigation for DESONATE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Bayer Healthcare Pharmaceuticals, Inc. v. River's Edge Pharmaceuticals, LLC | 2011-05-19 |
| Medicis Pharmaceutical Corporation v. Actavis Mid Atlantic LLC | 2011-05-11 |
| Medicis Pharmaceutical Corporation v. Acella Pharmaceuticals, LLC | 2010-08-19 |
Pharmacology for DESONATE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Synonyms for DESONATE
| (11ss,16alpha)-11,21-Dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione |
| (1S,2S,4R,8S,9S,11S,12S,13R)-11-hydroxy-8-(2-hydroxyacetyl)-6,6,9,13-tetramethyl-5,7-dioxapentacyclo[10.8.0.0;{2,9}.0;{4,8}.0;{13,18}]icosa-14,17-dien-16-one |
| (4aR,4bS,5S,6aS,6bS,9aR,10aS,10bS)-5-hydroxy-6b-(hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one |
| 11beta,16alpha,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone |
| 11beta,21-dihydroxy-16alpha,17-[(1-methylethylidene)bis(oxy)]pregna-1,4-diene-3,20-dione |
| 11beta,21-dihydroxy-16alpha,17-isopropylidenedioxypregna-1,4-diene-3,20-dione |
| 11beta,21-dihydroxy-16alpha,17alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione |
| 16-alpha-Hydroxyprednisole-16,17-acetonide |
| 16?,17-[1-Methylethylidenebis(oxy)]-11?,21-dihydroxypregna-1,4-diene-3,20-dione |
| 16alpha-hydroxyprednisole-16,17-acetonide |
| 16alpha-hydroxyprednisolone-16alpha,17-acetonide |
| 16alpha,17-[1-Methylethylidenebis(oxy)]-11beta,21-dihydroxypregna-1,4-diene-3,20-dione (Desonide) |
| 16alpha,17alpha-isopropylidenedioxyprednisolone |
| 638-94-8 |
| 638D948 |
| AB01274712_02 |
| AB01274712-01 |
| AB2000229 |
| Apolar |
| AS-13892 |
| BCP04201 |
| BRD-K21528677-001-03-6 |
| C-22009 |
| CAS-638-94-8 |
| CC-26356 |
| CCG-221279 |
| CHEBI:204734 |
| CHEMBL1201109 |
| CS-2228 |
| D 2083 |
| D-2083 |
| D03696 |
| D2083 |
| DB01260 |
| desfluorotriamcinolone acetonide |
| Desilux |
| Desonida |
| Desonida [INN-Spanish] |
| DESONIDE |
| Desonide (USAN/INN) |
| Desonide [USAN:INN:BAN] |
| Desonidum |
| Desonidum [INN-Latin] |
| DesOwen |
| Desowen (TN) |
| DSSTox_CID_26756 |
| DSSTox_GSID_46756 |
| DSSTox_RID_81880 |
| DTXSID7046756 |
| EINECS 211-351-6 |
| Flusemidon |
| GTPL7066 |
| Hamiltoderm |
| HMS3715P20 |
| HY-B0248 |
| J280872D1O |
| K016 |
| Locapred |
| Locapred;Topifug;Tridesilon |
| MolPort-003-987-087 |
| NCGC00167983-01 |
| NCGC00274065-01 |
| Prednacinolone |
| Prednisolone-16,17-acetonide, 16-alpha-hydroxy- |
| Pregna-1,4-diene-3,20-dione, 11,21-dihydroxy-16,17-((1-methylethylidene)bis(oxy))-, (11beta,16alpha)- |
| Prenacid |
| Q-101382 |
| Reticus |
| s1701 |
| SC-17104 |
| SCHEMBL3631 |
| Sterax |
| Steroderm |
| TL8004516 |
| Topifug |
| Tox21_112603 |
| Tox21_112603_1 |
| Tridesilon |
| Tridesonit |
| UNII-J280872D1O |
| Verdeso |
| Verdeso (TN) |
| WBGKWQHBNHJJPZ-LECWWXJVSA-N |
| ZINC4212851 |
| Zotinar |
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 | 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 |
|---|---|---|
| Portugal | 1304992 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0211683 | Start Trial |
| China | 101305982 | Start Trial |
| Japan | 4988129 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DESONATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1304992 | 2013/044 | Ireland | Start Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
| 1304992 | C01304992/01 | Switzerland | Start Trial | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
| 1304992 | PA2013025,C1304992 | Lithuania | Start Trial | PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
| 1304992 | PA2013025 | Lithuania | Start Trial | PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
