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Last Updated: June 14, 2021

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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 Generics, Perrigo Israel, Taro, Schering, Merck Sharp Dohme, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Akorn, Teligent, Alpharma Us Pharms, Fougera Pharms Inc, Invatech, Lupin Ltd, Cadila, Taro Pharms, Primus Pharms, Leo Pharma As, MC2, Perrigo Uk Finco, Tolmar, and Glenmark Pharms, and is included in seventy-three NDAs. There are sixteen 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 sixty-six 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

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Recent Clinical Trials for betamethasone dipropionate

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

SponsorPhase
University of Alabama at BirminghamPhase 4
Eli Lilly and CompanyPhase 4
Cairo UniversityN/A

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Pharmacology for betamethasone dipropionate
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 NDA Submissiondate
SERNIVO SPRAY;TOPICAL betamethasone dipropionate 208079 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
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Taro BETAMETHASONE DIPROPIONATE betamethasone dipropionate OINTMENT;TOPICAL 074271-001 Sep 15, 1994 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Fougera Pharms Inc BETAMETHASONE DIPROPIONATE betamethasone dipropionate LOTION;TOPICAL 070275-001 Aug 12, 1985 AB RX No Yes   Get Started Free   Get Started Free   Get Started Free
Mc2 WYNZORA betamethasone dipropionate; calcipotriene CREAM;TOPICAL 213422-001 Jul 20, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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 CREAM, AUGMENTED;TOPICAL 019408-001 Jan 31, 1986   Get Started Free   Get Started Free
Merck Sharp Dohme DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741-001 Jul 27, 1983   Get Started Free   Get Started Free
Merck Sharp Dohme DIPROLENE AF betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019555-001 Apr 27, 1987   Get Started Free   Get Started Free
Schering DIPROLENE betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019408-001 Jan 31, 1986   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Merck
Express Scripts
Johnson and Johnson
AstraZeneca

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.