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Last Updated: August 8, 2020

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Dexamethasone - Generic Drug Details

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What are the generic drug 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, Lannett Co Inc, Lyne, Wockhardt Bio Ag, Aspen Global Inc, Allergan, Ocular Therapeutix, Watson Labs, Novartis, Eyepoint Pharms, 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, Solvay, Dexcel Pharma, Watson Labs Teva, Ucb Inc, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, 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, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz Inc, Alcon Pharms Ltd, Perrigo Co Tennessee, and Eyevance, and is included in one hundred and thirty-one NDAs. There are twenty-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has two hundred and eighteen patent family members in thirty countries.

There are thirty-nine drug master file entries for dexamethasone. Twenty-nine suppliers are listed for this compound.

Drug Prices for dexamethasone

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Drug Sales Revenue Trends for dexamethasone

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Recent Clinical Trials for dexamethasone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NeuroActiva, Inc.Phase 2/Phase 3
University of LeipzigPhase 3
Arch OncologyPhase 1/Phase 2

See all dexamethasone clinical trials

Pharmacology for dexamethasone
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
Novartis TOBRADEX dexamethasone; tobramycin OINTMENT;OPHTHALMIC 050616-001 Sep 28, 1988 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hikma DEXAMETHASONE dexamethasone TABLET;ORAL 084610-001 Approved Prior to Jan 1, 1982 AB RX 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

Supplementary Protection Certificates for dexamethasone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1581193 C300552 Netherlands   Start Trial PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
1429780 SPC/GB12/058 United Kingdom   Start 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
1581193 122012000081 Germany   Start Trial PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
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Colorcon
AstraZeneca
Boehringer Ingelheim
Johnson and Johnson

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