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Mometasone furoate - Generic Drug Details

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

This ingredient has sixty-eight patent family members in twenty-nine countries.

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

Summary for Generic Name: mometasone furoate

Tradenames:5
Patents:6
Applicants:9
NDAs:24
Drug Master File Entries: see list26
Suppliers / Packaging: see list20
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: mometasone furoate

Clinical Trials for: mometasone furoate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo
MOMETASONE FUROATE
mometasone furoate
LOTION;TOPICAL077180-001Apr 6, 2005RXNo<disabled><disabled>
Apotex Inc
MOMETASONE FUROATE
mometasone furoate
SPRAY, METERED;NASAL091161-001Mar 22, 2016RXNo<disabled><disabled>
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 2005RXYes6,240,918*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: mometasone furoate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
NASONEX
mometasone furoate
SPRAY, METERED;NASAL020762-001Oct 1, 19976,723,713*PED<disabled>
Merck Sharp Dohme
ELOCON
mometasone furoate
LOTION;TOPICAL019796-001Mar 30, 19894,775,529*PED<disabled>
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 20055,889,015*PED<disabled>
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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
7,687,073Preparation of powder agglomerates<disabled in preview>
6,495,167 Preparation of powder agglomerates<disabled in preview>
5,687,710 Inhaler for powdered medications having spiral deagglomeration chamber<disabled in preview>
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International Patent Family for Ingredient: mometasone furoate

Country Document Number Estimated Expiration
South Africa9701324<disabled in preview>
Malaysia115140<disabled in preview>
European Patent Office0674533<disabled in preview>
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Supplementary Protection Certificates for Tradename: MOMETASONE FUROATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0002Belgium<disabled>PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
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