Dexamethasone - Generic Drug Details
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What are the generic sources for dexamethasone and what is the scope of freedom to operate?
Dexamethasone
is the generic ingredient in thirty-four branded drugs marketed by Allergan Herbert, Merck, Hikma, Alpharma Us Pharms, Anima, Chartwell Molecular, Lyne, Pharmobedient Cnsltg, Aspen Global Inc, Abbvie, Ocular Therapeutix, Watson Labs, Harrow Eye, Eyepoint Pharms, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Impax Labs, Larken Labs Inc, Novitium Pharma, Pangea, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Zydus Pharms, Solvay, Dexcel, Watson Labs Teva, Ucb Inc, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Geneyork Pharms, Gland Pharma Ltd, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, West-ward Pharms Int, Wyeth Ayerst, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz, Alcon Pharms Ltd, Novartis, and Padagis Us, and is included in one hundred and forty-seven NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dexamethasone has seventy-one patent family members in twenty countries.
There are thirty-nine drug master file entries for dexamethasone. Forty suppliers are listed for this compound.
Summary for dexamethasone
International Patents: | 71 |
US Patents: | 14 |
Tradenames: | 34 |
Applicants: | 64 |
NDAs: | 147 |
Drug Master File Entries: | 39 |
Finished Product Suppliers / Packagers: | 40 |
Raw Ingredient (Bulk) Api Vendors: | 115 |
Clinical Trials: | 3,400 |
Patent Applications: | 7,332 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for dexamethasone |
What excipients (inactive ingredients) are in dexamethasone? | dexamethasone excipients list |
DailyMed Link: | dexamethasone at DailyMed |
Recent Clinical Trials for dexamethasone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Carl Ola Landgren, MD, PhD | Phase 2 |
Dipenkumar Modi | Phase 2 |
National Trauma Center | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novitium Pharma | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 215604-005 | Oct 5, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Zydus Pharms | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 216283-001 | Feb 7, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Merck | DECADRON | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 012071-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Solvay | DEXONE 0.75 | dexamethasone | TABLET;ORAL | 084993-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Epic Pharma Llc | DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 084493-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aspen Global Inc | HEXADROL | dexamethasone | TABLET;ORAL | 012675-009 | 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 |
Expired US Patents for dexamethasone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912-001 | Feb 9, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912-001 | Feb 9, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for dexamethasone
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 |
International Patents for dexamethasone
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 276048 | מערכות, ערכות ושיטות להעמסה והעברה של כמות קטנה של מינון ממזרק (Systems, kits and methods for loading and delivering a small volume dose from a syringe) | ⤷ Try a Trial |
European Patent Office | 3003318 | UTILISATION DE LA DÉXAMÉTHASONE À LIBÉRATION PROLONGÉE DANS UNE INFLAMMATION APRÈS UNE CHIRURGIE DE LA CATARACTE (USE OF SUSTAINED RELEASE DEXAMETHASONE IN POST-CATARACT SURGERY INFLAMMATION) | ⤷ Try a Trial |
Serbia | 58825 | VOĐICE ZA DOZIRANJE ZA INJEKCIONI ŠPRIC (DOSE GUIDES FOR INJECTION SYRINGE) | ⤷ Try a Trial |
South Korea | 20160040471 | 백내장 수술 후 염증에서의 서방출 덱사메타손의 용도 (USE OF SUSTAINED RELEASE DEXAMETHASONE IN POST-CATARACT SURGERY INFLAMMATION) | ⤷ Try a Trial |
European Patent Office | 2701773 | GUIDES DE DOSE POUR SERINGUE D'INJECTION (DOSE GUIDES FOR INJECTION SYRINGE) | ⤷ Try a Trial |
Denmark | 2701773 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dexamethasone
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1429780 | SPC/GB12/058 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
1429780 | 13C0012 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 |
1581193 | SPC/GB12/047 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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