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Last Updated: September 18, 2020

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Arformoterol tartrate - Generic Drug Details

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What are the generic sources for arformoterol tartrate and what is the scope of freedom to operate?

Arformoterol tartrate is the generic ingredient in one branded drug marketed by Sunovion and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Arformoterol tartrate has thirty-three patent family members in thirteen countries.

There are four drug master file entries for arformoterol tartrate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for arformoterol tartrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, Los AngelesPhase 4
SunovionPhase 2
SunovionPhase 4

See all arformoterol tartrate clinical trials

Generic filers with tentative approvals for ARFORMOTEROL TARTRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial15MCG(BASE)/2MLSOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for arformoterol tartrate
Paragraph IV (Patent) Challenges for ARFORMOTEROL TARTRATE
Tradename Dosage Ingredient NDA Submissiondate
BROVANA SOLUTION;INHALATION arformoterol tartrate 021912 2009-10-01

US Patents and Regulatory Information for arformoterol tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 arformoterol tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006   Start Trial   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006   Start Trial   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006   Start Trial   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006   Start Trial   Start Trial
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
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Express Scripts

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.