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Drug Pipeline MONTHLY UPDATE NEW DRUG INFORMATION ● Triferic Avnu ™ (ferric pyrophosphate citrate): The U.S. Food and Drug Administration (FDA) approved Rockwell Medical’s Triferic Avnu, an iron replacement product, to maintain hemoglobin in adults with hemodialysis-dependent chronic kidney disease (HDD-CKD). Triferic Avnu joins Rockwell Medical’s Triferic Dialysate (liquid bicarbonate administration) as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with HDD-CKD. Triferic Avnu is administered via intravenous infusion regardless of a dialysis center’s mode of bicarbonate delivery. 1 Rockwell plans to launch Triferic Avnu closer to the third quarter in 2020, with pricing information to follow. GENERIC DRUG INFORMATION ● Nexium ® (esomeprazole): Cipla launched their generic version of AstraZeneca’s Nexium granules for the treatment of gastroesophageal reflux disease (GERD) and gastric ulcer. No exclusivities remain for Nexium granules. Nexium granules generated $43 million in U.S. annual sales in 2019. ● Tepadina ® (thiotepa): Amneal Biosciences launched their generic version of Adienne’s Tepadina for the treatment of certain forms of cancer. Tepadina generated $24 million in U.S. annual sales in 2019. ● Proventil HFA ® (albuterol HFA): Cipla launched their generic version of Merck’s Proventil HFA for treatment of asthma, COPD and shortness of breath. Cipla’s generic version of Proventil HFA is the ﬁrst FDA-approved, therapeutically equivalent, albuterol sulfate HFA inhaler. It is unclear whether any additional exclusivities remain for Proventil HFA. Proventil-HFA had annual U.S. sales of $105 million in 2019. ProAir HFA ® , an additional substitutable version of Proventil-HFA (albuterol sulfate HFA 108mcg/act), had annual U.S. sales of $1.4 billion in 2019. While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. April 2020 Critical updates in an ever-changing environment

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Drug Pipeline MONTHLY UPDATE

NEW DRUG INFORMATION ● Triferic Avnu™ (ferric pyrophosphate citrate): The U.S. Food and Drug Administration (FDA)

approved Rockwell Medical’s Triferic Avnu, an iron replacement product, to maintain hemoglobin in adults with hemodialysis-dependent chronic kidney disease (HDD-CKD). Triferic Avnu joins Rockwell Medical’s Triferic Dialysate (liquid bicarbonate administration) as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with HDD-CKD. Triferic Avnu is administered via intravenous infusion regardless of a dialysis center’s mode of bicarbonate delivery.1 Rockwell plans to launch Triferic Avnu closer to the third quarter in 2020, with pricing information to follow.

GENERIC DRUG INFORMATION ● Nexium® (esomeprazole): Cipla launched their generic version of AstraZeneca’s Nexium granules for

the treatment of gastroesophageal reflux disease (GERD) and gastric ulcer. No exclusivities remain for Nexium granules. Nexium granules generated $43 million in U.S. annual sales in 2019.

● Tepadina® (thiotepa): Amneal Biosciences launched their generic version of Adienne’s Tepadina for the treatment of certain forms of cancer. Tepadina generated $24 million in U.S. annual sales in 2019.

● Proventil HFA® (albuterol HFA): Cipla launched their generic version of Merck’s Proventil HFA for treatment of asthma, COPD and shortness of breath. Cipla’s generic version of Proventil HFA is the first FDA-approved, therapeutically equivalent, albuterol sulfate HFA inhaler. It is unclear whether any additional exclusivities remain for Proventil HFA. Proventil-HFA had annual U.S. sales of $105 million in 2019. ProAir HFA®, an additional substitutable version of Proventil-HFA (albuterol sulfate HFA 108mcg/act), had annual U.S. sales of $1.4 billion in 2019.

While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner.

April 2020

Critical updates in an ever-changing environment

Page 2: Drug Pipeline MONTHLY UPDATE · Drug Pipeline MONTHLY UPDATE NEW DRUG INFORMATION Triferic Avnu™ (ferric pyrophosphate citrate): The U.S. Food and Drug Administration (FDA) approved

Drug Pipeline Monthly Update: April 2020 Page 2

REFERENCES1. https://www.globenewswire.com/news-release/2020/03/27/2007742/0/en/Rockwell-Medical-Inc-Receives-FDA-Approval-for-Triferic-AVNU-Ferric-Pyrophosphate-Citrate-Intravenous-Formulation-of-Triferic-for-

Replacement-of-Iron-and-Maintenance-of-Hemoglobin-.html

All brand names are property of their respective owners.

2992-A1 © Prime Therapeutics LLC 04/20

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