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Last Updated: September 21, 2021

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Betamethasone acetate; betamethasone sodium phosphate - Generic Drug Details

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What are the generic drug sources for betamethasone acetate; betamethasone sodium phosphate and what is the scope of patent protection?

Betamethasone acetate; betamethasone sodium phosphate is the generic ingredient in two branded drugs marketed by Am Regent and Merck Sharp Dohme, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for betamethasone acetate; betamethasone sodium phosphate. Six suppliers are listed for this compound.

Summary for betamethasone acetate; betamethasone sodium phosphate
Recent Clinical Trials for betamethasone acetate; betamethasone sodium phosphate

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

SponsorPhase
Tel-Aviv Sourasky Medical CenterN/A
University of KentuckyEarly Phase 1

See all betamethasone acetate; betamethasone sodium phosphate clinical trials

Pharmacology for betamethasone acetate; betamethasone sodium phosphate
Anatomical Therapeutic Chemical (ATC) Classes for betamethasone acetate; betamethasone sodium phosphate
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
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
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
D07AC Corticosteroids, potent (group III)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XC Corticosteroids, potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL 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
R03BA Glucocorticoids
R03B OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
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

US Patents and Regulatory Information for betamethasone acetate; betamethasone 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 Sharp Dohme CELESTONE SOLUSPAN betamethasone acetate; betamethasone sodium phosphate INJECTABLE;INJECTION 014602-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Am Regent BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE betamethasone acetate; betamethasone sodium phosphate INJECTABLE;INJECTION 090747-001 Jul 31, 2009 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 betamethasone acetate; betamethasone sodium phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CELESTONE SOLUSPAN betamethasone acetate; betamethasone sodium phosphate INJECTABLE;INJECTION 014602-001 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Baxter
AstraZeneca
Harvard Business School
Colorcon

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