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. Seventeen 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 BELCHER on July 29th, 2014.
Summary for EPIPEN JR.
| International Patents: | 47 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 11 |
| Patent Applications: | 4,599 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for EPIPEN JR.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Automatic injector with kickback attenuation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Automatic injector with needle cover
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Automatic injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Automatic injector with needle cover
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Mylan Speciality Lp | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Mylan Speciality Lp | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Mylan Speciality Lp | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| >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 | See Plans and Pricing | |
| Australia | 2013222015 | AUTOMATIC INJECTOR | See Plans and Pricing |
| Cyprus | 1115201 | See Plans and Pricing | |
| Portugal | 2204201 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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