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Last Updated: November 2, 2024

DEXAMETHASONE SODIUM PHOSPHATE - Generic Drug Details


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What are the generic sources for dexamethasone sodium phosphate and what is the scope of patent protection?

Dexamethasone sodium phosphate is the generic ingredient in thirteen branded drugs marketed by Ucb Inc, Merck, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Amneal, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Geneyork Pharms, Gland Pharma Ltd, Hikma, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Wyeth Ayerst, Aspen Global Inc, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz, and Alcon Pharms Ltd, and is included in fifty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for dexamethasone sodium phosphate. Nineteen suppliers are listed for this compound.

Summary for DEXAMETHASONE SODIUM PHOSPHATE
US Patents:0
Tradenames:13
Applicants:31
NDAs:59
Drug Master File Entries: 11
Finished Product Suppliers / Packagers: 19
Raw Ingredient (Bulk) Api Vendors: 87
Clinical Trials: 66
Patent Applications: 7,142
What excipients (inactive ingredients) are in DEXAMETHASONE SODIUM PHOSPHATE?DEXAMETHASONE SODIUM PHOSPHATE excipients list
DailyMed Link:DEXAMETHASONE SODIUM PHOSPHATE at DailyMed
Recent Clinical Trials for DEXAMETHASONE SODIUM PHOSPHATE

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

SponsorPhase
BiotrialPhase 3
Quince Therapeutics S.p.A.Phase 3
Huro Biotech Joint Stock CompanyN/A

See all DEXAMETHASONE SODIUM PHOSPHATE clinical trials

Pharmacology for DEXAMETHASONE SODIUM PHOSPHATE
Anatomical Therapeutic Chemical (ATC) Classes for DEXAMETHASONE SODIUM PHOSPHATE
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A06AD Osmotically acting laxatives
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A06AG Enemas
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
B05XA Electrolyte solutions
B05X I.V. SOLUTION ADDITIVES
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XB Corticosteroids, moderately potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
V03AG Drugs for treatment of hypercalcemia
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various

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
Eugia Pharma DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 206781-001 Dec 1, 2015 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 210967-001 Jun 7, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Labs Ltd DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 040802-001 Aug 29, 2008 AP RX 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
Gland Pharma Ltd DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 215654-001 Aug 4, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 087668-001 Jul 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merck DECADRON dexamethasone sodium phosphate OINTMENT;OPHTHALMIC 011977-001 Approved Prior to Jan 1, 1982 DISCN No 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

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