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Last Updated: May 17, 2022

ASMANEX HFA Drug Patent Profile


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Which patents cover Asmanex Hfa, and what generic alternatives are available?

Asmanex Hfa is a drug marketed by Organon and is included in one NDA.

The generic ingredient in ASMANEX HFA is mometasone furoate. There are thirty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Asmanex Hfa

A generic version of ASMANEX HFA was approved as mometasone furoate by PADAGIS US on March 18th, 2002.

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US Patents and Regulatory Information for ASMANEX HFA

ASMANEX HFA is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting ASMANEX HFA

NEW STRENGTH
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-003 Aug 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-002 Apr 25, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-003 Aug 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 ASMANEX HFA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-001 Apr 25, 2014 See Plans and Pricing See Plans and Pricing
Organon ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-002 Apr 25, 2014 See Plans and Pricing See Plans and Pricing
Organon ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-001 Apr 25, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ASMANEX HFA

See the table below for patents covering ASMANEX HFA around the world.

Country Patent Number Title Estimated Expiration
Finland 962828 See Plans and Pricing
Japan 2003313128 USE OF MOMETASONE FUROATE FOR TREATING AIRWAY PASSAGE AND LUNG DISEASE See Plans and Pricing
Japan 2008031184 USE OF MOMETASONE FUROATE FOR TREATING AIRWAY PASSAGE AND LUNG DISEASE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ASMANEX HFA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0112669 96C0002 Belgium See Plans and Pricing PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
0548114 SPC/GB97/064 United Kingdom See Plans and Pricing PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.