FORMOTEROL FUMARATE - Generic Drug Details
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What are the generic drug 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 |
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 |
Pharmacology for FORMOTEROL FUMARATE
Drug Class | beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists |
Medical Subject Heading (MeSH) Categories for FORMOTEROL FUMARATE
Anatomical Therapeutic Chemical (ATC) Classes for FORMOTEROL FUMARATE
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294-001 | Apr 25, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294-001 | Apr 25, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-003 | Aug 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Lupin | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215053-001 | Aug 22, 2022 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Astrazeneca | BEVESPI AEROSPHERE | formoterol fumarate; glycopyrrolate | AEROSOL, METERED;INHALATION | 208294-001 | Apr 25, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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
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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