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Last Updated: December 3, 2022

Arformoterol tartrate - Generic Drug Details


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

Arformoterol tartrate is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Cipla, Glenmark Pharms Ltd, Lupin, Ritedose Corp, Slate Run Pharma, Sun Pharm, Teva Pharms Usa, and Sunovion, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for arformoterol tartrate. Eight suppliers are listed for this compound.

Drug Prices for arformoterol tartrate

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Recent Clinical Trials for arformoterol tartrate

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SponsorPhase
University of California, Los AngelesPhase 4
Dartmouth-Hitchcock Medical CenterPhase 4
SunovionPhase 2

See all arformoterol tartrate clinical trials

Pharmacology for arformoterol tartrate
Paragraph IV (Patent) Challenges for ARFORMOTEROL TARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BROVANA Inhalation Solution arformoterol tartrate Eq. 0.015 mg base/ 2 mL 021912 1 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
Ritedose Corp ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 214736-001 Mar 2, 2022 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 214779-001 May 10, 2022 AN RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 200293-001 Nov 9, 2021 AN RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 AN RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glenmark Pharms Ltd ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 213132-001 Jun 22, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 213068-001 Feb 7, 2022 AN RX No 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 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 See Plans and Pricing See Plans and Pricing
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 See Plans and Pricing See Plans and Pricing
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 See Plans and Pricing See Plans and Pricing
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 See Plans and Pricing See Plans and Pricing
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 See Plans and Pricing See Plans and Pricing
Sunovion BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.