Epinephrine - Generic Drug Details
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What are the generic sources for epinephrine and what is the scope of patent protection?
Epinephrine
is the generic ingredient in thirty-five branded drugs marketed by Sterling, Armstrong Pharms, Wyeth Cons, Forest Labs, Mylan Speciality Lp, Impax, Teva Pharms Usa, Endo Operations, Am Regent, Bpi Labs, Fresenius Kabi Usa, Gland, Intl Medication Sys, Kaleo Inc, Adamis Pharms Corp, Hospira, Ars Pharms Operation, 3M, Baxter Hlthcare Corp, Astrazeneca, Dentsply Pharm, Deproco, Septodont Inc, Carlisle, B Braun Medical Inc, Belmora Llc, Eastman Kodak, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Vyteris, Iomed, and Empi, and is included in sixty-six NDAs. There are thirty-five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Epinephrine has two hundred and seventy-six patent family members in thirty-two countries.
There are twenty-one drug master file entries for epinephrine. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for epinephrine
International Patents: | 276 |
US Patents: | 35 |
Tradenames: | 35 |
Applicants: | 38 |
NDAs: | 66 |
Drug Master File Entries: | 21 |
Finished Product Suppliers / Packagers: | 26 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 714 |
Patent Applications: | 7,112 |
Drug Prices: | Drug price trends 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 |
---|---|
Montefiore Medical Center | N/A |
University Hospital "Sestre Milosrdnice" | N/A |
Jessyka Lighthall | Phase 3 |
Generic filers with tentative approvals for EPINEPHRINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try for Free | ⤷ Try for Free | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | DURANEST | epinephrine bitartrate; etidocaine hydrochloride | INJECTABLE;INJECTION | 017751-006 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Forest Labs | SUS-PHRINE SULFITE FREE | epinephrine | INJECTABLE;INJECTION | 007942-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Pharmaton | LIDOCATON | epinephrine; lidocaine hydrochloride | INJECTABLE;INJECTION | 084728-001 | Aug 17, 1983 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 epinephrine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Impax | ADRENACLICK | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 020800-004 | Nov 25, 2009 | 10,166,334 | ⤷ Try for Free |
Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-001 | Aug 10, 2012 | 8,608,698 | ⤷ Try for Free |
Kaleo Inc | AUVI-Q | epinephrine | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 201739-002 | Aug 10, 2012 | 8,361,029 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for epinephrine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
United Kingdom | 2471981 | Medicament delivery device having an electronic circuit system | ⤷ Try for Free |
Japan | 2018507915 | エピネフリン製剤 | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2019157099 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for epinephrine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3678649 | 122025000010 | Germany | ⤷ Try for Free | PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822 |
3678649 | CA 2025 00007 | Denmark | ⤷ Try for Free | PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823 |
3678649 | PA2025507 | Lithuania | ⤷ Try for Free | PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Epinephrine
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