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Last Updated: March 19, 2024

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, Cipla, Glenmark Pharms Ltd, Lupin, Mankind Pharma, Ritedose Corp, Slate Run Pharma, Slayback Pharma Llc, Sun Pharm, and Teva Pharms Usa, and is included in eleven 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

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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
Teva Pharms Usa ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 200293-001 Nov 9, 2021 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 215385-001 May 26, 2022 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Slayback Pharma Llc ARFORMOTEROL TARTRATE arformoterol tartrate SOLUTION;INHALATION 216815-001 Nov 25, 2022 AN RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 AN RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
Lupin BROVANA arformoterol tartrate SOLUTION;INHALATION 021912-001 Oct 6, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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