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DEXAMETHASONE Drug Profile
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When do Dexamethasone patents expire, and what generic alternatives are available?
Dexamethasone is a drug marketed by Alpharma Us Pharms, Anima, Lannett Co Inc, Lyne, Wockhardt Bio Ag, Abraxis Pharm, Fresenius Kabi Usa, Hikma, Watson Labs, Ani Pharms Inc, ECR, Fera Pharms Llc, Heritage Pharma, Impax Labs, Larken Labs Inc, Par Pharm, Phoenix Labs Ny, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Watson Labs Teva, Akorn, Amneal, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Dr Reddys, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, West-ward Pharms Int, Wyeth Ayerst, Sola Barnes Hind, Bausch And Lomb, and Sandoz Inc. and is included in eighty-three NDAs.
The generic ingredient in DEXAMETHASONE is dexamethasone acetate. There are thirty-nine drug master file entries for this compound. Additional details are available on the dexamethasone acetate profile page.
Summary for DEXAMETHASONE
| US Patents: | 0 |
| Applicants: | 42 |
| NDAs: | 83 |
| Suppliers / Packagers: | 27 |
| Bulk Api Vendors: | 101 |
| Clinical Trials: | 2,763 |
| Patent Applications: | 4,341 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DEXAMETHASONE |
| Drug Sales Revenues: | Drug sales revenues for DEXAMETHASONE |
| DailyMed Link: | DEXAMETHASONE at DailyMed |
See drug prices for DEXAMETHASONE
Recent Clinical Trials for DEXAMETHASONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Omar Nadeem | Phase 2 |
| Hospital of Southern Jutland | N/A |
| Herning Hospital | N/A |
Pharmacology for DEXAMETHASONE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for DEXAMETHASONE
US Patents and Regulatory Information for DEXAMETHASONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 083702-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 085458-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Industries | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 084084-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Somerset Theraps Llc | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 207442-001 | Apr 19, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs Teva | DEXAMETHASONE ACETATE | dexamethasone acetate | INJECTABLE;INJECTION | 087711-001 | May 24, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 203129-001 | Sep 30, 2015 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 085840-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
