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, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, and Wilshire Pharms Inc. and is included in seven NDAs.
The generic ingredient in FORMOTEROL FUMARATE is formoterol fumarate. There are nineteen drug master file entries for this compound. Thirteen 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.
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Questions you can ask:
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Summary for FORMOTEROL FUMARATE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 248 |
| Clinical Trials: | 139 |
| Patent Applications: | 4,019 |
| 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 | ⤷ 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 | |||
| Lupin | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215053-001 | Aug 22, 2022 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mankind Pharma | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 215883-001 | Mar 22, 2023 | 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 | |||
| Ritedose Corp | FORMOTEROL FUMARATE | formoterol fumarate | SOLUTION;INHALATION | 216486-001 | Nov 25, 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 |
