EPIPEN JR. Drug Patent Profile
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Which patents cover Epipen Jr., and when can generic versions of Epipen Jr. launch?
Epipen Jr. is a drug marketed by Viatris and is included in one NDA.
The generic ingredient in EPIPEN JR. is epinephrine. There are twenty-one drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Epipen Jr.
A generic version of EPIPEN JR. was approved as epinephrine by BPI LABS on July 29th, 2014.
Paragraph IV (Patent) Challenges for EPIPEN JR.
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| 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 EPIPEN JR.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
International Patents for EPIPEN JR.
See the table below for patents covering EPIPEN JR. around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | E026641 | ⤷ Start Trial | |
| Japan | 2009090140 | AUTOMATIC SYRINGE | ⤷ Start Trial |
| Poland | 2179759 | ⤷ Start Trial | |
| European Patent Office | 2204201 | Injecteur automatique (Automatic injector) | ⤷ Start Trial |
| Singapore | 139748 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EPIPEN JR.
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
