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 two branded drugs marketed by Aiping Pharm Inc, Alembic, Cf Pharmtech, Cipla, Dr Reddys, Glenmark Pharms Ltd, Lupin, Mankind Pharma, Ritedose Corp, Slate Run Pharma, Sun Pharm, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for arformoterol tartrate

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	14
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	9
Patent Applications:	211
Drug Prices:	Drug price trends for arformoterol tartrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for arformoterol tartrate
What excipients (inactive ingredients) are in arformoterol tartrate?	arformoterol tartrate excipients list
DailyMed Link:	arformoterol tartrate at DailyMed

See drug prices for arformoterol tartrate

Recent Clinical Trials for arformoterol tartrate

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

Sponsor	Phase
University of California, Los Angeles	Phase 4
Dartmouth-Hitchcock Medical Center	Phase 4
Sunovion	Phase 2

See all arformoterol tartrate clinical trials

Pharmacology for arformoterol tartrate

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for arformoterol tartrate

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	214779-001	May 10, 2022	AN	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	213132-001	Jun 22, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cf Pharmtech	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	216303-001	May 17, 2024	AN	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	ARFORMOTEROL TARTRATE	arformoterol tartrate	SOLUTION;INHALATION	213068-001	Feb 7, 2022	AN	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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