DEXONE 0.5 Drug Patent Profile
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When do Dexone 0.5 patents expire, and when can generic versions of Dexone 0.5 launch?
Dexone 0.5 is a drug marketed by Solvay and is included in one NDA.
The generic ingredient in DEXONE 0.5 is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dexone 0.5
A generic version of DEXONE 0.5 was approved as dexamethasone by XSPIRE PHARMA on April 28th, 1983.
Summary for DEXONE 0.5
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 115 |
Clinical Trials: | 138 |
Patent Applications: | 4,444 |
Formulation / Manufacturing: | see details |
DailyMed Link: | DEXONE 0.5 at DailyMed |
Recent Clinical Trials for DEXONE 0.5
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Southwest Oncology Group | Phase 3 |
University of Southern California | Phase 1/Phase 2 |
Rashmi Verma, MD | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for DEXONE 0.5
US Patents and Regulatory Information for DEXONE 0.5
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Solvay | DEXONE 0.5 | dexamethasone | TABLET;ORAL | 084991-001 | Approved Prior to Jan 1, 1982 | DISCN | 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 |
EU/EMA Drug Approvals for DEXONE 0.5
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
AbbVie Deutschland GmbH & Co. KG | Ozurdex | dexamethasone | EMEA/H/C/001140 Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. |
Authorised | no | no | no | 2010-07-26 | |
THERAVIA | Neofordex | dexamethasone | EMEA/H/C/004071 Treatment of multiple myeloma. |
Authorised | no | no | no | 2016-03-16 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |