BETAMETHASONE VALERATE - Generic Drug Details

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

Betamethasone valerate is the generic ingredient in eight branded drugs marketed by Alembic, Novast Labs, Padagis Israel, Taro, Xiromed, Norvium Bioscience, Cosette, Roaco, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Savage Labs, Schering, Actavis Mid Atlantic, Sciegen Pharms Inc, and Teva Pharms, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for betamethasone valerate. Fourteen suppliers are listed for this compound.

Summary for BETAMETHASONE VALERATE

US Patents:	0
Tradenames:	8
Applicants:	17
NDAs:	33
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	18
Patent Applications:	6,469
Drug Prices:	Drug price trends for BETAMETHASONE VALERATE
What excipients (inactive ingredients) are in BETAMETHASONE VALERATE?	BETAMETHASONE VALERATE excipients list
DailyMed Link:	BETAMETHASONE VALERATE at DailyMed

See drug prices for BETAMETHASONE VALERATE

Recent Clinical Trials for BETAMETHASONE VALERATE

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

Sponsor	Phase
Assiut University	Phase 1
Queen Mary Hospital, Hong Kong	Phase 3
Assiut University	Phase 4

See all BETAMETHASONE VALERATE clinical trials

Pharmacology for BETAMETHASONE VALERATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for BETAMETHASONE VALERATE

Anti-Inflammatory Agents
Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE VALERATE

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

Paragraph IV (Patent) Challenges for BETAMETHASONE VALERATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUXIQ	Foam	betamethasone valerate	0.12%	020934	1	2007-08-10

US Patents and Regulatory Information for BETAMETHASONE VALERATE

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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
Schering	VALISONE	betamethasone valerate	CREAM;TOPICAL	016322-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	LUXIQ	betamethasone valerate	AEROSOL, FOAM;TOPICAL	020934-001	Feb 28, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Schering	VALISONE	betamethasone valerate	LOTION;TOPICAL	016932-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	BETAMETHASONE VALERATE	betamethasone valerate	AEROSOL, FOAM;TOPICAL	207144-001	May 24, 2017		DISCN	No	No	⤷ 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
Schering	VALISONE	betamethasone valerate	CREAM;TOPICAL	016322-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	BETAMETHASONE VALERATE	betamethasone valerate	AEROSOL, FOAM;TOPICAL	078337-001	Nov 26, 2012	AB	RX	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 VALERATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	LUXIQ	betamethasone valerate	AEROSOL, FOAM;TOPICAL	020934-001	Feb 28, 1999	⤷ Sign Up	⤷ Sign Up
Norvium Bioscience	LUXIQ	betamethasone valerate	AEROSOL, FOAM;TOPICAL	020934-001	Feb 28, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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