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-one 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.
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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: | 4,289 |
| 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 |
US Patents and Regulatory Information for EPIPEN
EPIPEN is protected by five US patents.
Patents protecting EPIPEN
Automatic injector
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Automatic injector with kickback attenuation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Automatic injector with needle cover
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Automatic injector
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Automatic injector with needle cover
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Mylan Speciality Lp | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Mylan Speciality Lp | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | AB | 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 |
International Patents for EPIPEN
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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