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, Hikma, Organon, Parke Davis, Anda Repository, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Taro, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Aurobindo Pharma Ltd, Lupin Ltd, Tasman Pharma, Zydus Lifesciences, Primus Pharms, Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Glenmark Speclt, Watson Labs, Alembic, Novast Labs, Xiromed, Norvium Bioscience, Roaco, Pharmafair, Kanchan Hlthcare, and Teva Pharms, and is included in one hundred and twenty-two NDAs. There are seventeen 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.

Summary for betamethasone

US Patents:	17
Tradenames:	26
Applicants:	42
NDAs:	122
Drug Master File Entries:	66
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	200
Patent Applications:	6,594
Drug Prices:	Drug price trends for betamethasone
Drug Sales Revenues:	Drug sales revenues for betamethasone
DailyMed Link:	betamethasone at DailyMed

See drug prices for betamethasone

Recent Clinical Trials for betamethasone

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

Sponsor	Phase
Dermavant Sciences, Inc.	Phase 2/Phase 3
Wake Forest University Health Sciences	Phase 2/Phase 3
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	Phase 3

See all betamethasone clinical trials

Medical Subject Heading (MeSH) Categories for betamethasone

Anti-Asthmatic Agents
Anti-Inflammatory Agents
Glucocorticoids

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

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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
Cosette	BETA-VAL	betamethasone valerate	LOTION;TOPICAL	070072-001	Jun 27, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	BETAMETHASONE VALERATE	betamethasone valerate	LOTION;TOPICAL	071883-001	Apr 22, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	076592-001	Dec 9, 2003	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	DIPROLENE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	019408-001	Jan 31, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	DIPROLENE	betamethasone dipropionate	GEL, AUGMENTED;TOPICAL	019408-002	Nov 22, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmafair	BETAMETHASONE VALERATE	betamethasone valerate	OINTMENT;TOPICAL	070486-001	May 29, 1987		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

Expired US Patents for betamethasone

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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	⤷ Sign Up	⤷ Sign Up
Schering	CELESTONE	betamethasone	TABLET;ORAL	012657-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	CELESTONE	betamethasone	SYRUP;ORAL	014215-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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