Last Updated: May 10, 2026

BETAMETHASONE DIPROPIONATE Drug Patent Profile

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Which patents cover Betamethasone Dipropionate, and when can generic versions of Betamethasone Dipropionate launch?

Betamethasone Dipropionate is a drug marketed by 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, Hikma, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Lupin Ltd, Tp Anda Holdings, and Zydus Lifesciences. and is included in forty-eight NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Betamethasone Dipropionate

A generic version of BETAMETHASONE DIPROPIONATE was approved as betamethasone dipropionate by FOUGERA PHARMS on June 26^th, 1984.

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Summary for BETAMETHASONE DIPROPIONATE

US Patents:	0
Applicants:	21
NDAs:	48
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	73
Patent Applications:	4,842
Drug Prices:	Drug price information for BETAMETHASONE DIPROPIONATE
Drug Sales Revenues:	Drug sales revenues for BETAMETHASONE DIPROPIONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BETAMETHASONE DIPROPIONATE
What excipients (inactive ingredients) are in BETAMETHASONE DIPROPIONATE?	BETAMETHASONE DIPROPIONATE excipients list
DailyMed Link:	BETAMETHASONE DIPROPIONATE at DailyMed

Drug patent expirations by year for BETAMETHASONE DIPROPIONATE

Drug Prices for BETAMETHASONE DIPROPIONATE

Recent Clinical Trials for BETAMETHASONE DIPROPIONATE

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

Sponsor	Phase
MC2 Therapeutics	PHASE3
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.	PHASE3
Jinnah Postgraduate Medical Centre	PHASE1

See all BETAMETHASONE DIPROPIONATE clinical trials

Pharmacology for BETAMETHASONE DIPROPIONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE DIPROPIONATE

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 DIPROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SERNIVO	Topical Spray	betamethasone dipropionate	0.05%	208079	1	2018-02-15

US Patents and Regulatory Information for BETAMETHASONE DIPROPIONATE

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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
Padagis Israel	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT;TOPICAL	215847-001	Apr 12, 2022	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharma Canada	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	LOTION;TOPICAL	074272-001	Sep 30, 1994		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Teva	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT;TOPICAL	071477-001	Aug 10, 1987		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	LOTION;TOPICAL	209896-001	Feb 6, 2018		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Actavis Mid Atlantic	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	OINTMENT, AUGMENTED;TOPICAL	074304-001	Aug 31, 1995	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Padagis Us	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	LOTION;TOPICAL	072538-001	Jan 31, 1990	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Chartwell Molecular	BETAMETHASONE DIPROPIONATE	betamethasone dipropionate	CREAM, AUGMENTED;TOPICAL	076603-001	Jan 23, 2004		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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