DEXAMETHASONE INTENSOL Drug Patent Profile
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Which patents cover Dexamethasone Intensol, and when can generic versions of Dexamethasone Intensol launch?
Dexamethasone Intensol is a drug marketed by Hikma and is included in one NDA.
The generic ingredient in DEXAMETHASONE INTENSOL is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dexamethasone Intensol
A generic version of DEXAMETHASONE INTENSOL was approved as dexamethasone by KEY THERAP on April 28th, 1983.
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Questions you can ask:
- What is the 5 year forecast for DEXAMETHASONE INTENSOL?
- What are the global sales for DEXAMETHASONE INTENSOL?
- What is Average Wholesale Price for DEXAMETHASONE INTENSOL?
Summary for DEXAMETHASONE INTENSOL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 87 |
| Patent Applications: | 4,444 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DEXAMETHASONE INTENSOL |
| DailyMed Link: | DEXAMETHASONE INTENSOL at DailyMed |
Recent Clinical Trials for DEXAMETHASONE INTENSOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 1 |
| Southwest Oncology Group | Phase 3 |
| University of Southern California | Phase 1/Phase 2 |
Pharmacology for DEXAMETHASONE INTENSOL
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for DEXAMETHASONE INTENSOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | DEXAMETHASONE INTENSOL | dexamethasone | CONCENTRATE;ORAL | 088252-001 | Sep 1, 1983 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 DEXAMETHASONE INTENSOL
| 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 |
