FORMOTEROL FUMARATE Drug Patent Profile
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Which patents cover Formoterol Fumarate, and what generic alternatives are available?
Formoterol Fumarate is a drug marketed by Alembic, Aucta, Lupin, Mankind Pharma, Slayback Pharma Llc, and Teva Pharms Usa Inc. and is included in six NDAs.
The generic ingredient in FORMOTEROL FUMARATE is formoterol fumarate. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Formoterol Fumarate
A generic version of FORMOTEROL FUMARATE was approved as formoterol fumarate by TEVA PHARMS USA INC on June 22nd, 2021.
Summary for FORMOTEROL FUMARATE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 248 |
| Clinical Trials: | 137 |
| Patent Applications: | 4,008 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215078-001 | Nov 22, 2021 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mankind Pharma | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215883-001 | Mar 22, 2023 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aucta | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 216486-001 | Nov 25, 2022 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Lupin | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215053-001 | Aug 22, 2022 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa Inc | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 091141-001 | Jun 22, 2021 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Slayback Pharma Llc | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215621-001 | Dec 13, 2022 | AN | RX | No | No | ⤷ 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 |
