Last Updated: May 20, 2026

BETAMETHASONE Drug Patent Profile

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When do Betamethasone patents expire, and when can generic versions of Betamethasone launch?

Betamethasone is a drug marketed by Am Regent, Hikma, Chartwell Molecular, Fougera Pharms, Glenmark Pharms, Padagis Israel, Sun Pharma Canada, Actavis Mid Atlantic, Aurobindo Pharma Ltd, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Lupin Ltd, Tp Anda Holdings, Zydus Lifesciences, Watson Labs, Alembic, Ingenus Pharms Llc, Taro, Xiromed, Pharmafair, Senores Pharms, and Teva Pharms. and is included in seventy-one NDAs.

The generic ingredient in BETAMETHASONE is betamethasone valerate. There are sixty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the betamethasone valerate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Betamethasone

A generic version of BETAMETHASONE was approved as betamethasone valerate by FOUGERA PHARMS INC on August 31^st, 1983.

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Summary for BETAMETHASONE

US Patents:	0
Applicants:	30
NDAs:	71
Drug Prices:	Drug price information for BETAMETHASONE
Drug Sales Revenues:	Drug sales revenues for BETAMETHASONE
DailyMed Link:	BETAMETHASONE at DailyMed

Drug patent expirations by year for BETAMETHASONE

Drug Prices for BETAMETHASONE

Recent Clinical Trials for BETAMETHASONE

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Sponsor	Phase
Region Skane	PHASE4
Greta and Johan Kock Foundation	PHASE4
MC2 Therapeutics	PHASE3

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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Mid Atlantic	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT;TOPICAL	071012-001	Feb 3, 1987	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Shree Hari Intl	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	LOTION;TOPICAL	070274-001	Aug 12, 1985		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Lifesciences	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT;TOPICAL	214048-001	Jul 14, 2020	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharmafair	BETAMETHASONE VALERATE	betamethasone valerate	CREAM;TOPICAL	070485-001	May 29, 1987		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharmaderm	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT;TOPICAL	019140-001	Sep 4, 1984		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharma Canada	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	SPRAY;TOPICAL	211722-001	Jun 17, 2020		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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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