EPIPEN Drug Patent Profile
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Which patents cover Epipen, and when can generic versions of Epipen launch?
Epipen is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are five patents protecting this drug.
This drug has forty-seven patent family members in eighteen countries.
The generic ingredient in EPIPEN is epinephrine. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Epipen
A generic version of EPIPEN was approved as epinephrine by BPI LABS on July 29th, 2014.
Summary for EPIPEN
International Patents: | 47 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 11 |
Patent Applications: | 4,335 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EPIPEN |
Drug Sales Revenues: | Drug sales revenues for EPIPEN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPIPEN |
What excipients (inactive ingredients) are in EPIPEN? | EPIPEN excipients list |
DailyMed Link: | EPIPEN at DailyMed |
Recent Clinical Trials for EPIPEN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jeffrey Alan Klein, MD | Phase 2/Phase 3 |
Nasus Pharma | Phase 1 |
Apimeds, Inc. | Phase 3 |
Pharmacology for EPIPEN
Drug Class | Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for EPIPEN
US Patents and Regulatory Information for EPIPEN
EPIPEN is protected by five US patents.
Patents protecting EPIPEN
Automatic injector
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Automatic injector with kickback attenuation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Automatic injector with needle cover
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Automatic injector
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Automatic injector with needle cover
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Mylan Speciality Lp | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Mylan Speciality Lp | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Mylan Speciality Lp | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Mylan Speciality Lp | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for EPIPEN
See the table below for patents covering EPIPEN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1122922 | ⤷ Try a Trial | |
Spain | 2792185 | ⤷ Try a Trial | |
European Patent Office | 1786491 | INJECTEUR AUTOMATIQUE (AUTOMATIC INJECTOR) | ⤷ Try a Trial |
European Patent Office | 2311510 | Injecteur automatique (Automatic injector) | ⤷ Try a Trial |
Cyprus | 1115201 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |