HEXADROL Drug Patent Profile
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Which patents cover Hexadrol, and what generic alternatives are available?
Hexadrol is a drug marketed by Aspen Global Inc and is included in three NDAs.
The generic ingredient in HEXADROL is dexamethasone sodium phosphate. There are thirty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexamethasone sodium phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Hexadrol
A generic version of HEXADROL was approved as dexamethasone sodium phosphate by WEST-WARD PHARMS INT on September 7th, 1982.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for HEXADROL?
- What are the global sales for HEXADROL?
- What is Average Wholesale Price for HEXADROL?
Summary for HEXADROL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 165 |
| Patent Applications: | 6,331 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | HEXADROL at DailyMed |
Recent Clinical Trials for HEXADROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical College of Wisconsin | Phase 2 |
| Southwest Oncology Group | Phase 3 |
| University of Southern California | Phase 1/Phase 2 |
US Patents and Regulatory Information for HEXADROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aspen Global Inc | HEXADROL | dexamethasone | ELIXIR;ORAL | 012674-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen Global Inc | HEXADROL | dexamethasone | TABLET;ORAL | 012675-009 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen Global Inc | HEXADROL | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 014694-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen Global Inc | HEXADROL | dexamethasone | TABLET;ORAL | 012675-010 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen Global Inc | HEXADROL | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 014694-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen Global Inc | HEXADROL | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 014694-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen Global Inc | HEXADROL | dexamethasone | TABLET;ORAL | 012675-007 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 HEXADROL
| 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 |
