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ASMANEX TWISTHALER Drug Profile

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Asmanex Twisthaler is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug.

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

The generic ingredient in ASMANEX TWISTHALER is mometasone furoate. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for Tradename: ASMANEX TWISTHALER

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: ASMANEX TWISTHALER

Clinical Trials for: ASMANEX TWISTHALER

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-002Feb 1, 2008RXNo8,173,172*PED<disabled>Y<disabled>
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 2005RXYes6,240,918*PED<disabled>Y<disabled>
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-002Feb 1, 2008RXNo5,829,434*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ASMANEX TWISTHALER

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 20055,829,434*PED<disabled>
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 20055,394,868*PED<disabled>
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 20056,057,307*PED<disabled>
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Non-Orange Book Patents for Tradename: ASMANEX TWISTHALER

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
5,687,710 Inhaler for powdered medications having spiral deagglomeration chamber<disabled in preview>
7,687,073Preparation of powder agglomerates<disabled in preview>
6,495,167 Preparation of powder agglomerates<disabled in preview>
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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 Tradename: ASMANEX TWISTHALER

Country Document Number Estimated Expiration
Norway313085<disabled in preview>
South Korea100453610<disabled in preview>
South Africa9309472<disabled in preview>
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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: ASMANEX TWISTHALER

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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