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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Federal Trade Commission
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Generated: December 13, 2017

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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 betamethasone dipropionate patent protection?

Betamethasone dipropionate
is the generic ingredient in eleven branded drugs marketed by Fougera Pharms, Glenmark Generics, Perrigo New York, Taro, Tolmar, Schering, Merck Sharp Dohme, Savage Labs, Actavis Mid Atlantic, Pharmaderm, Teva, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Teligent Pharma Inc, Promius Pharma Llc, Leo Pharma As, Perrigo Israel, and Glenmark Pharms, and is included in sixty-one NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Betamethasone dipropionate has six patent family members in four countries.

There are sixty-six drug master file entries for betamethasone dipropionate. Twenty-one suppliers are listed for this compound.

Pharmacology for BETAMETHASONE DIPROPIONATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Fougera PharmsBETAMETHASONE DIPROPIONATEbetamethasone dipropionateGEL, AUGMENTED;TOPICAL075276-001May 13, 2003ABRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Promius Pharma LlcSERNIVObetamethasone dipropionateSPRAY;TOPICAL208079-001Feb 5, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Leo Pharma AsTACLONEXbetamethasone dipropionate; calcipotriene hydrateSUSPENSION;TOPICAL022185-001May 9, 2008RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Mid AtlanticBETAMETHASONE DIPROPIONATEbetamethasone dipropionateOINTMENT;TOPICAL071012-001Feb 3, 1987ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TevaBETAMETHASONE DIPROPIONATEbetamethasone dipropionateOINTMENT;TOPICAL071477-001Aug 10, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PharmadermBETAMETHASONE DIPROPIONATEbetamethasone dipropionateOINTMENT;TOPICAL019140-001Sep 4, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fougera Pharms IncBETAMETHASONE DIPROPIONATEbetamethasone dipropionateLOTION;TOPICAL070275-001Aug 12, 1985ABRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Leo Pharma AsTACLONEXbetamethasone dipropionate; calcipotriene hydrateOINTMENT;TOPICAL021852-001Jan 9, 2006ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeDIPROLENE AFbetamethasone dipropionateCREAM, AUGMENTED;TOPICAL019555-001Apr 27, 1987ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
G And W Labs IncBETAMETHASONE DIPROPIONATEbetamethasone dipropionateLOTION;TOPICAL071467-001Aug 10, 1987ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: betamethasone dipropionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ScheringDIPROLENEbetamethasone dipropionateCREAM, AUGMENTED;TOPICAL019408-001Jan 31, 1986► Subscribe► Subscribe
Merck Sharp DohmeDIPROLENEbetamethasone dipropionateOINTMENT, AUGMENTED;TOPICAL018741-001Jul 27, 1983► Subscribe► Subscribe
ScheringDIPROLENEbetamethasone dipropionateGEL, AUGMENTED;TOPICAL019408-002Nov 22, 1991► Subscribe► Subscribe
Merck Sharp DohmeDIPROLENEbetamethasone dipropionateLOTION, AUGMENTED;TOPICAL019716-001Aug 1, 1988► Subscribe► Subscribe
Merck Sharp DohmeDIPROLENE AFbetamethasone dipropionateCREAM, AUGMENTED;TOPICAL019555-001Apr 27, 1987► Subscribe► Subscribe
ScheringDIPROLENEbetamethasone dipropionateCREAM, AUGMENTED;TOPICAL019408-001Jan 31, 1986► Subscribe► Subscribe
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International Patent Family for Ingredient: betamethasone dipropionate

Country Document Number Estimated Expiration
Denmark2473161► Subscribe
World Intellectual Property Organization (WIPO)2011026076► Subscribe
Japan5833007► Subscribe
European Patent Office3141246► Subscribe
Japan2013503203► Subscribe
European Patent Office2473161► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Julphar
Queensland Health
Accenture
Farmers Insurance
Mallinckrodt
Express Scripts
Boehringer Ingelheim
McKinsey
Colorcon
Healthtrust

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 verifification 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.

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