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

Sponsor	Phase
Quince Therapeutics S.p.A.	Phase 3
Biotrial	Phase 3
Vietstar Biomedical Research	N/A

See all DEXAMETHASONE SODIUM PHOSPHATE clinical trials

Pharmacology for DEXAMETHASONE SODIUM PHOSPHATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Parenteral	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	INJECTABLE;INJECTION	081126-001	Aug 31, 1990		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	SOLUTION/DROPS;OTIC	084855-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aspen Global Inc	HEXADROL	dexamethasone sodium phosphate	INJECTABLE;INJECTION	014694-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	INJECTABLE;INJECTION	215654-002	Sep 25, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alcon Pharms Ltd	NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate; neomycin sulfate	SOLUTION/DROPS;OPHTHALMIC	062714-001	Jul 21, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	INJECTABLE;INJECTION	085606-001	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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