Formoterol fumarate - Generic Drug Details

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What are the generic sources for formoterol fumarate and what is the scope of patent protection?

Formoterol fumarate is the generic ingredient in six branded drugs marketed by Novartis, Alembic, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, Wilshire Pharms Inc, Mylan Speclt, Astrazeneca, and Organon Llc, and is included in twelve NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for formoterol fumarate. Thirteen suppliers are listed for this compound.

Summary for formoterol fumarate

US Patents:	7
Tradenames:	6
Applicants:	11
NDAs:	12
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	248
Clinical Trials:	139
Patent Applications:	6,841
Drug Prices:	Drug price trends for formoterol fumarate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for formoterol fumarate
What excipients (inactive ingredients) are in formoterol fumarate?	formoterol fumarate excipients list
DailyMed Link:	formoterol fumarate at DailyMed

See drug prices for formoterol fumarate

Recent Clinical Trials for formoterol fumarate

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
SGS S.A.	Phase 1
Université de Sherbrooke	N/A

See all formoterol fumarate clinical trials

Pharmacology for formoterol fumarate

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

Medical Subject Heading (MeSH) Categories for formoterol fumarate

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for formoterol fumarate

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 FORMOTEROL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PERFOROMIST	Inhalation Solution	formoterol fumarate	0.02 mg/2 mL	022007	1	2009-01-21

US Patents and Regulatory Information for formoterol fumarate

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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
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	AN	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wilshire Pharms Inc	FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	215621-001	Dec 13, 2022	AN	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Micro Labs	FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	218304-001	Jun 26, 2024	AN	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa Inc	FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	091141-001	Jun 22, 2021	AN	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006		DISCN	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 formoterol fumarate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FORADIL	formoterol fumarate	POWDER;INHALATION	020831-001	Feb 16, 2001	⤷ Sign Up	⤷ Sign Up
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006	⤷ Sign Up	⤷ Sign Up
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	⤷ Sign Up	⤷ Sign Up
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	⤷ Sign Up	⤷ Sign Up
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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