EPINEPHRINE Drug Patent Profile
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Which patents cover Epinephrine, and what generic alternatives are available?
Epinephrine is a drug marketed by Armstrong Pharms, Am Regent, Amneal, Baxter Hlthcare Corp, Bpi Labs, Fresenius Kabi Usa, Gland, Intl Medication Sys, Hospira, and Teva Pharms Usa. and is included in sixteen NDAs. There is one patent protecting this drug and one Paragraph IV challenge.
The generic ingredient in EPINEPHRINE is epinephrine bitartrate. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate profile page.
DrugPatentWatch® Generic Entry Outlook for Epinephrine
Annual sales in 2022 were $454mm indicating the motivation for generic entry (peak sales were $610mm in 2019).
There have been thirty-two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (epinephrine bitartrate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for EPINEPHRINE?
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Summary for EPINEPHRINE
| US Patents: | 1 |
| Applicants: | 10 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 824 |
| Patent Applications: | 2,334 |
| Drug Prices: | Drug price information for EPINEPHRINE |
| Drug Sales Revenues: | Drug sales revenues for EPINEPHRINE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPINEPHRINE |
| What excipients (inactive ingredients) are in EPINEPHRINE? | EPINEPHRINE excipients list |
| DailyMed Link: | EPINEPHRINE at DailyMed |
Recent Clinical Trials for EPINEPHRINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Francisco | PHASE2 |
| Hospital del Trabajador de Santiago | NA |
| Goldman, Butterwick, Fitzpatrick and Groff | PHASE4 |
Pharmacology for EPINEPHRINE
| Drug Class | Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Medical Subject Heading (MeSH) Categories for EPINEPHRINE
Anatomical Therapeutic Chemical (ATC) Classes for EPINEPHRINE
Paragraph IV (Patent) Challenges for EPINEPHRINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NEFFY | Nasal Spray | epinephrine | 1 mg/spray | 214697 | 1 | 2025-12-29 |
| NEFFY | Nasal Spray | epinephrine | 2 mg/spray | 214697 | 1 | 2025-06-30 |
| EPINEPHRINE | Injection | epinephrine | 1 mg/mL | 205029 | 1 | 2020-08-13 |
| ADRENALIN | Injection | epinephrine | 30 mg/30 mL | 204640 | 1 | 2018-08-20 |
| ADRENALIN | Injection | epinephrine | 1 mg/mL ampules | 204200 | 1 | 2016-03-09 |
| EPIPEN JR. | Injection (Auto- injector) | epinephrine | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | 019430 | 1 | 2009-07-20 |
US Patents and Regulatory Information for EPINEPHRINE
EPINEPHRINE is protected by one US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Armstrong Pharms | EPINEPHRINE | epinephrine | AEROSOL, METERED;INHALATION | 087907-001 | May 23, 1984 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bpi Labs | EPINEPHRINE | epinephrine | SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | 205029-001 | Jul 29, 2014 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Baxter Hlthcare Corp | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | epinephrine bitartrate | SOLUTION;INTRAVENOUS | 218475-001 | Feb 28, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Baxter Hlthcare Corp | EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 220626-002 | Mar 30, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
