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Last Updated: November 2, 2024

BETAMETHASONE DIPROPIONATE - Generic Drug Details


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

Betamethasone dipropionate is the generic ingredient in thirteen branded drugs marketed by Anda Repository, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Taro, Schering, Organon, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Encube, Hikma, 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, and Merck Sharp Dohme, and is included in seventy-seven NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Betamethasone dipropionate has seven patent family members in five countries.

There are thirteen drug master file entries for betamethasone dipropionate. Twenty-five suppliers are listed for this compound.

Drug Prices for BETAMETHASONE DIPROPIONATE

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Drug Sales Revenue Trends for BETAMETHASONE DIPROPIONATE

See drug sales revenues for BETAMETHASONE DIPROPIONATE

Recent Clinical Trials for BETAMETHASONE DIPROPIONATE

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

SponsorPhase
Wake Forest University Health SciencesPhase 2/Phase 3
Dermavant Sciences, Inc.Phase 2/Phase 3
Oticara Australia PTY LTDPhase 2

See all BETAMETHASONE DIPROPIONATE clinical trials

Pharmacology for BETAMETHASONE DIPROPIONATE
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 201615-001 Jan 14, 2013 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharmaderm BETAMETHASONE DIPROPIONATE betamethasone dipropionate CREAM;TOPICAL 019136-001 Jun 26, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro BETAMETHASONE DIPROPIONATE betamethasone dipropionate CREAM;TOPICAL 073552-001 Apr 30, 1992 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cosette BETAMETHASONE DIPROPIONATE betamethasone dipropionate LOTION;TOPICAL 071882-001 Jun 6, 1988 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Shree Hari Intl BETAMETHASONE DIPROPIONATE betamethasone dipropionate LOTION;TOPICAL 070274-001 Aug 12, 1985 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
Schering DIPROSONE betamethasone dipropionate LOTION;TOPICAL 017781-001 Approved Prior to Jan 1, 1982 DISCN Yes 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 DIPROPIONATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering DIPROLENE betamethasone dipropionate GEL, AUGMENTED;TOPICAL 019408-002 Nov 22, 1991 ⤷  Sign Up ⤷  Sign Up
Schering DIPROLENE betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019408-001 Jan 31, 1986 ⤷  Sign Up ⤷  Sign Up
Organon DIPROLENE AF betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019555-001 Apr 27, 1987 ⤷  Sign Up ⤷  Sign Up
Organon DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741-001 Jul 27, 1983 ⤷  Sign Up ⤷  Sign Up
Schering DIPROLENE betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019408-001 Jan 31, 1986 ⤷  Sign Up ⤷  Sign Up
Organon DIPROLENE betamethasone dipropionate LOTION, AUGMENTED;TOPICAL 019716-001 Aug 1, 1988 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BETAMETHASONE DIPROPIONATE

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2011026076 ⤷  Sign Up
Japan 5833007 ⤷  Sign Up
European Patent Office 2473161 COMPOSITIONS TOPIQUES CONTENANT UN STÉROÏDE (TOPICAL FORMULATIONS COMPRISING A STEROID) ⤷  Sign Up
Spain 2637447 ⤷  Sign Up
Japan 2013503203 ⤷  Sign Up
Denmark 2473161 ⤷  Sign Up
European Patent Office 3141246 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.