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Last Updated: July 2, 2020

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Dexamethasone sodium phosphate - Generic Drug Details

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What are the generic drug sources for dexamethasone sodium phosphate and what is the scope of freedom to operate?

Dexamethasone sodium phosphate is the generic ingredient in thirteen branded drugs marketed by Ucb Inc, Merck, 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, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Aspen Global Inc, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz Inc, and Alcon Pharms Ltd, and is included in fifty-four NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for dexamethasone sodium phosphate

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

SponsorPhase
Weill Medical College of Cornell UniversityPhase 1
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2

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Pharmacology for dexamethasone sodium phosphate

US Patents and Regulatory Information for dexamethasone sodium phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck DECADRON dexamethasone sodium phosphate INJECTABLE;INJECTION 012071-004 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Merck DECADRON dexamethasone sodium phosphate SOLUTION/DROPS;OPHTHALMIC, OTIC 011984-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Amneal DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 208689-001 Aug 22, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Merck DECADRON dexamethasone sodium phosphate INJECTABLE;INJECTION 012071-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Alcon MAXIDEX dexamethasone sodium phosphate OINTMENT;OPHTHALMIC 083342-001 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Moodys
Boehringer Ingelheim
McKinsey
Baxter

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