Path to Approval First Truly Generic EpiPen

The very first EpiPen (epinephrine) generic was approved by the FDA in August, and will hopefully be available to pharmacies in the coming months. But what is the true impact of this approval? And wasn’t there already a generic EpiPen on the market? That is half correct.

Previously, EpiPen was rated in the orange book as BX, which meant there was insufficient data to determine therapeutic equivalence to another product. Yet, we saw a 'generic' EpiPen being advertised. What happened was that another company, which owned an epinephrine product (Adrenaclick), also made an authorized generic.

An authorized generic is different from a true generic in that it is esentially the same as the brand name product, just marketed as a generic product. This authorized generic was marketed as a 'generic' epinephrine pen with the same active ingredient as EpiPen. But because EpiPen and the authorized generic for Adrenaclick were not truly generic, these products were not interchangable, and pharmacies would have to call a provider’s office to switch to the authorized generic.

This table outlines the available epinephrine injectable drugs, therapeutic equivalence (TE), drug company, as well as approval date documented in the Orange Book online:

Proprietary Name

Strength

TE Code

Applicant Holder

Approval Date

ADRENACLICK

EQ 0.15MG/DELIVERY

BX

IMPAX LABORATORIES INC

Nov 25, 2009

ADRENACLICK

EQ 0.3MG/DELIVERY

BX

IMPAX LABORATORIES INC

Nov 25, 2009

EPINEPHRINE (AUTOINJECTOR)

0.15MG/DELIVERY

AB

TEVA PHARMACEUTICALS USA INC

Aug 16, 2018

EPINEPHRINE (AUTOINJECTOR)

0.3MG/DELIVERY

AB

TEVA PHARMACEUTICALS USA INC

Aug 16, 2018

EPIPEN

0.3MG/DELIVERY

AB

MYLAN SPECIALTY LP

Dec 22, 1987

EPIPEN JR.

0.15MG/DELIVERY

AB

MYLAN SPECIALTY LP

Dec 22, 1987

ADRENALIN

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP

PAR STERILE PRODUCTS LLC

Dec 7, 2012

ADRENALIN

EQ 30MG BASE/30ML (EQ 1MG BASE/ML)

PAR STERILE PRODUCTS LLC

Dec 18, 2013

EPINEPHRINE

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

AP

LUITPOLD PHARMACEUTICALS INC

Jul 6, 2018

In addition to these products, the FDA approved in September another new 0.15mg epinephrine injection (Symjepi, Adamis and Sandoz) for the emergency treatment of allergic reactions in children. Symjepi was previously approved for its 0.3 mg dose, and both products also are expected to arrive on the market soon.

Highlights for pharmacists:

• If you receive a prescription for EpiPen, you can switch to the AB rated generic epinephrine by Teva. You would not need to call provider for permission to make switch.
• If you receive a prescription for epinephrine pen, you can fill for what you have in stock and what is covered by insurance.
• If you receive a prescription for any other any other brand epinephrine, it would not be interchangable to any other brand epinephrine.

The approval of a drug and device combination is exceptionally tricky as patents protect both the drug and the device separately. The high cost of brand name drug device combinations has lead the FDA to announce their Drug Competition Action Plan in 2017 which seeks to improve the generic drug approval process.

While the generic EpiPen might be the first generic drug device combination approved, it will definitely not be the last. Hopefully, this approval will lead the way for more approvals of generic drug device combinations.

Drug Shortage Prompts Expiration Date Extension for Some Epinephrine Products