MAXIDEX Drug Patent Profile
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Which patents cover Maxidex, and when can generic versions of Maxidex launch?
Maxidex is a drug marketed by Alcon and Harrow Eye and is included in two NDAs.
The generic ingredient in MAXIDEX is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Maxidex
A generic version of MAXIDEX was approved as dexamethasone by HIKMA on September 15th, 1983.
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Questions you can ask:
- What is the 5 year forecast for MAXIDEX?
- What are the global sales for MAXIDEX?
- What is Average Wholesale Price for MAXIDEX?
Summary for MAXIDEX
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 34 |
| Patent Applications: | 4,415 |
| Drug Prices: | Drug price information for MAXIDEX |
| What excipients (inactive ingredients) are in MAXIDEX? | MAXIDEX excipients list |
| DailyMed Link: | MAXIDEX at DailyMed |
Recent Clinical Trials for MAXIDEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical College of Wisconsin | Phase 2 |
| Benha University | Phase 1 |
| Dana-Farber Cancer Institute | Phase 1 |
Pharmacology for MAXIDEX
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for MAXIDEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alcon | MAXIDEX | dexamethasone sodium phosphate | OINTMENT;OPHTHALMIC | 083342-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Harrow Eye | MAXIDEX | dexamethasone | SUSPENSION/DROPS;OPHTHALMIC | 013422-001 | Approved Prior to Jan 1, 1982 | RX | Yes | 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 MAXIDEX
| 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 |
