EPINEPHRINE Drug Patent Profile
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When do Epinephrine patents expire, and when can generic versions of Epinephrine launch?
Epinephrine is a drug marketed by Armstrong Pharms, Am Regent, Bpi Labs, Intl Medication Sys, Hospira, and Teva Pharms Usa. and is included in eight NDAs. There are three patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in EPINEPHRINE is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Epinephrine
A generic version of EPINEPHRINE was approved as epinephrine by BPI LABS on July 29th, 2014.
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Summary for EPINEPHRINE
| US Patents: | 3 |
| Applicants: | 6 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 714 |
| Patent Applications: | 2,245 |
| 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 |
See drug prices for EPINEPHRINE
Recent Clinical Trials for EPINEPHRINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Montefiore Medical Center | N/A |
| University Hospital "Sestre Milosrdnice" | N/A |
| Jessyka Lighthall | Phase 3 |
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 |
|---|---|---|---|---|---|---|
| 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 five US patents.
Patents protecting EPINEPHRINE
More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE 1), INCLUDING ANAPHYLAXIS; A METHOD OF TREATING ALLERGIC REACTION, ANAPHYLAXIS, ANAPHYLACTIC SHOCK, OR COMBINATION THEREOF BY AN INJECTION OF AT LEAST ONE DOSAGE OF THE INJECTABLE LIQUID PHARMACEUTICAL
More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INCREASING MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
More potent and less toxic formulations of epinephrine and methods of medical use
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INDUCTION AND MAINTENANCE OF MYDRIASIS DURING INTRAOCULAR SURGERY
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Intl Medication Sys | EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 211880-001 | Apr 24, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bpi Labs | EPINEPHRINE | epinephrine | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 205029-005 | Mar 4, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bpi Labs | EPINEPHRINE | epinephrine | SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS | 205029-001 | Jul 29, 2014 | 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 |
