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 Viatris and is included in one NDA.
The generic ingredient in EPIPEN is epinephrine. There are twenty-one drug master file entries for this compound. Thirty-two 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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Questions you can ask:
- What is the 5 year forecast for EPIPEN?
- What are the global sales for EPIPEN?
- What is Average Wholesale Price for EPIPEN?
Summary for EPIPEN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 15 |
| Patent Applications: | 4,125 |
| 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 |
|---|---|
| Insignis Therapeutics, Inc. | PHASE1 |
| Washington University School of Medicine | PHASE1 |
| De Motu Cordis | PHASE1 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viatris | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Viatris | EPIPEN E Z PEN | epinephrine | INJECTABLE;INTRAMUSCULAR | 019430-003 | Aug 3, 1995 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Viatris | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | AB | 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 |
Expired US Patents for EPIPEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | 8,870,827 | ⤷ Start Trial |
| Viatris | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | 7,449,012 | ⤷ Start Trial |
| Viatris | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | 8,048,035 | ⤷ Start Trial |
| Viatris | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | 9,586,010 | ⤷ Start Trial |
| Viatris | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | 7,794,432 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPIPEN
See the table below for patents covering EPIPEN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2005271355 | Automatic injector | ⤷ Start Trial |
| Australia | 2010201665 | Automatic injector with kickback attenuation | ⤷ Start Trial |
| Australia | 2013222015 | AUTOMATIC INJECTOR | ⤷ Start Trial |
| Canada | 2576776 | INJECTEUR AUTOMATIQUE (AUTOMATIC INJECTOR) | ⤷ Start Trial |
| Canada | 2683253 | INJECTEUR AUTOMATIQUE AVEC COUVRE-AIGUILLE (AUTOMATIC INJECTOR WITH NEEDLE COVER) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EPIPEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3678649 | LUC00378 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211 |
| 3678649 | 2025C/508 | Belgium | ⤷ Start Trial | PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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