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Last Updated: September 21, 2021

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Betamethasone - Generic Drug Details

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What are the generic sources for betamethasone and what is the scope of freedom to operate?

Betamethasone is the generic ingredient in twenty-six branded drugs marketed by Schering, Merck Sharp Dohme, Am Regent, Parke Davis, Anda Repository, Fougera Pharms, Glenmark Generics, Perrigo Israel, Taro, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Akorn, Teligent, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Pharmgen, Lupin Ltd, Cadila, Taro Pharms, Primus Pharms, Leo Pharma As, MC2, Padagis Israel, Tolmar, Glenmark Pharms, Watson Labs, Riconpharma Llc, Mylan, Roaco, Pharmafair, Anima, and Teva Pharms, and is included in one hundred and fifteen NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for betamethasone.

Drug Prices for betamethasone

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Recent Clinical Trials for betamethasone

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

SponsorPhase
University of Southern CaliforniaPhase 4
West Virginia UniversityPhase 4
Surface Pharmaceuticals, Inc.Phase 2

See all betamethasone clinical trials

Medical Subject Heading (MeSH) Categories for betamethasone
Anatomical Therapeutic Chemical (ATC) Classes for betamethasone
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole LOTION;TOPICAL 076493-001 Jul 28, 2004 AB RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Primus Pharms SERNIVO betamethasone dipropionate SPRAY;TOPICAL 208079-001 Feb 5, 2016 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Savage Labs BETATREX betamethasone valerate LOTION;TOPICAL 018867-001 Aug 31, 1983 DISCN 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering CELESTONE betamethasone CREAM;TOPICAL 014762-001 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Schering CELESTONE betamethasone TABLET;ORAL 012657-003 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme CELESTONE betamethasone SYRUP;ORAL 014215-002 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:

Merck
Harvard Business School
Johnson and Johnson
Boehringer Ingelheim
McKesson
Medtronic

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