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Serving leading biopharmaceutical companies globally:

Colorcon
Fuji
Merck
Teva
Express Scripts
Baxter
Healthtrust
Boehringer Ingelheim
Argus Health
Covington

Generated: December 17, 2017

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Mometasone furoate - Generic Drug Details

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What are the generic sources for mometasone furoate and what is the scope of mometasone furoate freedom to operate?

Mometasone furoate
is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Fougera Pharms, G And W Labs, Glenmark Generics, Taro, Tolmar, Perrigo Israel, Perrigo New York, Amneal Pharms, and Apotex Inc, and is included in twenty-five NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mometasone furoate has thirty-five patent family members in twenty-six countries and one supplementary protection certificate in one country.

There are twenty-nine drug master file entries for mometasone furoate. Twenty suppliers are listed for this compound.

Pharmacology for mometasone furoate

Medical Subject Heading (MeSH) Categories for mometasone furoate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex IncMOMETASONE FUROATEmometasone furoateSPRAY, METERED;NASAL091161-001Mar 22, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
G And W LabsMOMETASONE FUROATEmometasone furoateOINTMENT;TOPICAL077401-001Jun 20, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-002Feb 1, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Perrigo New YorkMOMETASONE FUROATEmometasone furoateOINTMENT;TOPICAL076067-001Mar 18, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
TolmarMOMETASONE FUROATEmometasone furoateOINTMENT;TOPICAL076481-001Nov 14, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-002Feb 1, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
TolmarMOMETASONE FUROATEmometasone furoateCREAM;TOPICAL076591-001Apr 18, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Fougera PharmsMOMETASONE FUROATEmometasone furoateLOTION;TOPICAL075919-001Nov 29, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
G And W LabsMOMETASONE FUROATEmometasone furoateCREAM;TOPICAL077447-001May 22, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-001Mar 30, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: mometasone furoate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-002Feb 1, 2008► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-002Feb 1, 2008► Subscribe► Subscribe
Merck Sharp DohmeASMANEX HFAmometasone furoateAEROSOL, METERED;INHALATION205641-002Apr 25, 2014► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-002Feb 1, 2008► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-001Mar 30, 2005► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-002Feb 1, 2008► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-001Mar 30, 2005► Subscribe► Subscribe
Merck Sharp DohmeELOCONmometasone furoateLOTION;TOPICAL019796-001Mar 30, 1989► Subscribe► Subscribe
Merck Sharp DohmeASMANEX HFAmometasone furoateAEROSOL, METERED;INHALATION205641-001Apr 25, 2014► Subscribe► Subscribe
Merck Sharp DohmeNASONEXmometasone furoateSPRAY, METERED;NASAL020762-001Oct 1, 1997► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: mometasone furoate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,495,167 Preparation of powder agglomerates► Subscribe
7,687,073Preparation of powder agglomerates► Subscribe
7,387,794Preparation of powder agglomerate► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: mometasone furoate

Country Document Number Estimated Expiration
Slovakia287878► Subscribe
New Zealand331361► Subscribe
Norway983832► Subscribe
Hungary221033► Subscribe
Poland328485► Subscribe
World Intellectual Property Organization (WIPO)9730743► Subscribe
Israel120246► Subscribe
Japan2000504955► Subscribe
China1216476► Subscribe
Czech Republic9802599► 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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Supplementary Protection Certificates for Tradename: MOMETASONE FUROATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0002Belgium► SubscribePRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
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Serving leading biopharmaceutical companies globally:

QuintilesIMS
US Army
Cantor Fitzgerald
Johnson and Johnson
Boehringer Ingelheim
McKinsey
Cerilliant
Merck
Fuji
Dow

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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