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, Chartwell Molecular, Kanchan Hlthcare, Pharmobedient Cnsltg, Rising, Aspen Global Inc, Abbvie, Ocular Therapeutix, Watson Labs, Harrow Eye, Eyepoint Pharms, Abraxeolus, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Corepharma, Impax Labs, Key Therap, Larken Labs Inc, Novitium Pharma, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Zydus Lifesciences, 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, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, 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-nine NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dexamethasone has seventy-two patent family members in twenty-one countries.
There are thirty-nine drug master file entries for dexamethasone. Forty-three suppliers are listed for this compound.
Summary for dexamethasone
International Patents: | 72 |
US Patents: | 14 |
Tradenames: | 34 |
Applicants: | 65 |
NDAs: | 149 |
Drug Master File Entries: | 39 |
Finished Product Suppliers / Packagers: | 43 |
Raw Ingredient (Bulk) Api Vendors: | 115 |
Clinical Trials: | 3,474 |
Patent Applications: | 7,383 |
Drug Prices: | Drug price trends for dexamethasone |
Drug Sales Revenues: | Drug sales revenues 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 |
---|---|
Albert Einstein College of Medicine | Phase 1 |
Columbia University | Phase 1 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 1 |
Pharmacology for dexamethasone
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for dexamethasone
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Phoenix Labs Ny | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 083806-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Teva Parenteral | DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 081126-001 | Aug 31, 1990 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Alvogen | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 088481-004 | Apr 28, 1983 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Geneyork Pharms | DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 214890-001 | Jul 7, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 084612-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912-001 | Feb 9, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Ocular Therapeutix | DEXTENZA | dexamethasone | INSERT;OPHTHALMIC | 208742-001 | Nov 30, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Canada | 2913336 | UTILISATION DE LA DEXAMETHASONE A LIBERATION PROLONGEE DANS UNE INFLAMMATION APRES UNE CHIRURGIE DE LA CATARACTE (USE OF SUSTAINED RELEASE DEXAMETHASONE IN POST-CATARACT SURGERY INFLAMMATION) | ⤷ Sign Up |
Japan | 5684239 | ⤷ Sign Up | |
Mexico | 2013012316 | GUIAS DE DOSIS PARA JERINGA DE INYECCION. (DOSE GUIDES FOR INJECTION SYRINGE.) | ⤷ Sign Up |
Canada | 2760704 | BIOMATERIAUX POUR LA FERMETURE DE VOIE ET DE PONCTION (BIOMATERIALS FOR TRACK AND PUNCTURE CLOSURE) | ⤷ Sign Up |
Japan | 6215193 | ⤷ Sign Up | |
>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 | ⤷ Sign Up | 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 |
1581193 | SPC/GB12/047 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727 |
1429780 | 13C0012 | France | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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