EPIPEN JR. Drug Patent Profile
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When do Epipen Jr. patents expire, and when can generic versions of Epipen Jr. launch?
Epipen Jr. is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has forty-seven patent family members in eighteen countries.
The generic ingredient in EPIPEN JR. 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 Jr.
A generic version of EPIPEN JR. 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 JR.?
- What are the global sales for EPIPEN JR.?
- What is Average Wholesale Price for EPIPEN JR.?
Summary for EPIPEN JR.
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: | 2,865 |
DailyMed Link: | EPIPEN JR. at DailyMed |
Recent Clinical Trials for EPIPEN JR.
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 JR.
Drug Class | Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
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.
EPIPEN JR. is protected by five US patents.
Patents protecting EPIPEN JR.
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 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 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 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 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 JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | 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 JR.
See the table below for patents covering EPIPEN JR. around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2792185 | ⤷ Sign Up | |
Taiwan | I407981 | ⤷ Sign Up | |
Cyprus | 1117383 | ⤷ Sign Up | |
Japan | 4362143 | ⤷ Sign Up | |
Cyprus | 1117076 | ⤷ Sign Up | |
Denmark | 1786491 | ⤷ Sign Up | |
Portugal | 2179759 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |