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.

Drug Pipeline Update

D Drug Insights > March 2017

New drug information ● Qtern™ (dapagliflozin/saxagliptin): The U.S. Food and

Drug Administration (FDA) approved AstraZeneca’s Qtern as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who have inadequate control with dapagliflozin (10 mg) or who are already treated with dapagliflozin and saxagliptin. It is the second SGLT2i/DPP4i combination drug approved, joining Glyxambi (empagliflozin/linagliptin).

● Odactra™ (house dust mite sublingual allergy immunotherapy [HDM SLIT]): The FDA approved Merck, Sharp & Dohme Corporation’s Odactra to treat HDM-induced nasal inflammation with or without eye inflammation in people 18 – 65 years of age. This is the first SLIT approved for HDM allergy. Other SLIT therapies are approved for grass allergies.

● Noctiva™ (desmopressin nasal spray): The FDA approved Allergan and Serenity Pharmaceuticals Noctiva for adults who awaken at least 2 times per night to urinate due to a condition known as nocturnal polyuria. Noctiva is administered intranasally daily approximately 30 minutes before going to bed. Although there are other FDA-approved medications that also contain desmopressin, none of those medication are FDA approved to treat nocturnal polyuria.

● Vyvanse® (lisdexamfetamine dimesylate chewable tablet): Shire’s Vyvanse chewable tablets were approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children 6 years and older and moderate to severe binge eating disorder (BED) in adults. Previously, Vyvanse was available as oral capsules. The capsules share the same indication as the chewable tablets.

● Xadago® (safinamide): Newron Pharmaceuticals received FDA approval of Xadago for add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing an ‘off’ episode. An ‘off’ episode occurs when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking.

Drug Pipeline > March 2017 Page 2

Generic drug information ● Ritalin® LA 60 mg (methylphenidate cap SR, 60 mg):

The first true generic for Novartis’ Ritalin LA 60 mg for the treatment of ADHD was launched by Mayne Pharma.

● Pristiq® (desvenlafaxine SR): The generic version of Pfizer’s Pristiq for the treatment of major depressive disorder has launched. Teva has marketing exclusivity for 180 days on its generic 25 mg tablets; the 50 mg and 100 mg tablets are available through multiple manufacturers. According to IMS Health, Pristiq (all strengths) had approximately $859.9 million in sales over the past year.

● Millipred® (prednisolone sodium phosphate oral solution 10 mg/5 mL): Edenbridge Pharmaceutical has launched the first generic for Zylera Pharmaceuticals’ Millipred to treat allergies, arthritis, breathing problems, certain blood disorders, collagen diseases such as lupus, certain eye diseases, cancer, endocrine issues, intestinal issues, swelling due to certain conditions, or skin conditions.

● Veripred® 20 (prednisolone sodium phosphate oral solution 20mg/5mL): Edenbridge Pharmaceutical has launched the first generic for Zylera Pharmaceuticals’ Veripred 20 for the treatment of severe allergies, arthritis, asthma, certain blood disorders, and skin conditions.

● Minastrin® 24 Fe (norethindrone/ethinyl estradiol/ferrous fumarate chew tab): Lupin Pharmaceuticals has launched the first generic for Actavis’ Minastrin 24 Fe for pregnancy prevention. According to IMS, Minastrin 24 Fe chewable tablets had U.S. annual sales of $360.5 million. Lupin will have 180-day exclusivity after which at least two manufacturers will launch their generic Minastrin 24 Fe products.

Drug Pipeline > March 2017 Page 3

New molecular entity approvals in the past 12 monthsGeneric name Brand name Manufacturer Indication(s) Date approved*

safinamide Xadago® Newron Pharmaceuticals

Parkinson’s disease March 2017

desmopressin nasal spray Noctiva™ Allergan and Serenity Nocturnal polyuria March 2017

house dust mite sublingual allergy immunotherapy

Odactra™ Merck, Sharp & Dohme

House dust mite allergies March 2017

plecanatide Trulance™ Synergy Chronic idiopathic constipation January 2017

crisaborole Eucrisa™ Pfizer/Anacor Mild to moderate atopic dermatitis December 2016

prasterone Intrarosa® Endoceutics Inc Pain during intercourse November 2016

lixisenatide Adlyxin® Sanofi Diabetes July 2016

lifitegrast Xiidra™ Shire Dry eye disease July 2016

pimavanserin Nuplazid™ Acadia Psychosis associated with Parkinson’s disease

April 2016

*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.

continued

Other new product approvals in the past 12 monthsGeneric name Brand name Manufacturer Indication(s) Date approved*

dapagliflozin/saxagliptin Qtern™ AstraZeneca Diabetes February 2016

lisdexamfetamine Vyvanse® Shire ADHD (chew tab) February 2017

naloxone nasal spray, 2 mg Narcan Adapt Pharma Inc Opioid overdose January 2016

fluticasone propionate ArmonAir™ RespiClick®

Teva Asthma January 2016

fluticasone propionate/salmeterol

AirDuo™ RespiClick® Teva Asthma January 2016

oxymetazoline Rhofade Allergan Rosacea January 2016

hydrocodone extended release Vantrela™ ER Teva Pain, abuse deterrent January 2016

morphine extended release Arymo™ ER Egalet Pain, abuse deterrent January 2016

insulin glargine Basaglar™ Lilly Diabetes December 2015, launched in December 2016

empagliflozin/metformin extended release

Synjardy® XR Eli Lilly Diabetes December 2016

Lantus® (insulin glargine)/ Adlyxin™ (lixisenatide)

Soliqua™ Sanofi Diabetes November 2016

Tresiba® (insulin degludec/Victoza® (liraglutide)

Xultophy® Novo Nordisk Diabetes November 2016

Drug Pipeline > March 2017 Page 4

Generic name Brand name Manufacturer Indication(s) Date approved*

doxylamine/pyridoxine XR Bonjesta® Duchesnay Pregnancy-related nausea and vomiting November 2016

tenofovir alafenamide Vemlidy® Gilead Hepatitis B November 2016

mebendazole Vermox® Johnson & Johnson/Janssen

Parasitic disease November 2016

norethindrone/estradiol fe Taytulla™ Apil Pregnancy prevention October 2016

sumatriptan/naproxen Treximet® Permix Migraine October 2016

levonorgestrel-releasing intrauterine system

Kyleena™ Bayer AG Pregnancy prevention September 2016

phentermine HCl Lomaira™ KVK Tech Weight loss September 2016

aspirin/omeprazole delayed-release

Yosprala™ Aralez Pharmaceuticals, Inc

Secondary prevention of CV disease in patients with high risk for ASA-induced ulcers

September 2016

oxycodone/naltrexone extended-release

Troxyca ER® Pfizer Pain August 2016

granisetron, extended-release injection

Sustol® Heron Therapeutics Prevention of chemotherapy-induced nausea and vomiting

August 2016

lisinopril oral solution Qbrelis™ Silvergate Pharmaceuticals, Inc

Hypertension July 2016

dronabinol Syndros™ Insys Therapeutics HIV wasting and chemotherapy induced nausea and vomiting in cancer patients.

July 2016

calcifediol ER Rayaldee® OPKO Health Chronic kidney disease and vitamin D insufficiency

June 2016

nitroglycerin sublingual powder Gonitro™ Espero Pharmaeuticals

Relief of angina pectoris June 2016

nebivolol/valsartan Byvalson™ Allergan Hypertension June 2016

linagliptin/metformin Jentadueto XR® Boehringer Ingelheim and Lilly

Diabetes May 2016

buprenorphine implant Probuphine™ Braeburn and Titan Maintenance treatment of opioid dependence

May 2016

oxycodone ER Xtampza™ Collegium Chronic pain May 2016

glycopyrrolate/formoterol Bevespi™ Aerosphere

AstraZeneca COPD May 2016

bromfenac 0.075% BromSite™ InSite Vision Inflammation and pain associated with cataract surgery

April 2016

*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.

Other new product approvals in the past 12 months (continued)

Drug Pipeline > March 2017 Page 5

Pipeline watch

Generic Name Brand Name Manufacturer Indication(s)Anticipated FDA Decision Date

abaloparatide N/A Radius Health Osteoporosis March 2017

naldemedine Symproic™ Shinonogi Opioid induced constipation March 2017

pharmaceutical grade L-glutamine

N/A Emmaus Life Science Sickle cell disease March – July 2017

MK-1293 (insulin glargine) N/A Merck Diabetes April 2017

estradiol Yuvvexy™ TherapeuticsMD Menopause symptoms May 2017

SUN-101/eFlow (glycopyrrolate) N/A Sunovion Pharmaceuticals

COPD May 2017

delafloxacin Baxdela™ Melinta Bacterial infection June 2017

ozenoxacin N/A Medimetriks Impetigo June 2017

methylphenidate ER Cotempla XR-ODT™ Neos Therapeutics ADHD June 2017

mixed amphetamine salts long acting

N/A Shire ADHD June 2017

epinephrine N/A Adamas Pharmaceuticals

Allergic reactions June 2017

betrixaban N/A Portola Pharmaceuticals

Prevention of venous thromboembolism (VTE)

June 2017

epinephrine N/A Adamis Pharmaceuticals

Allergic reactions June 2017

romosozumab N/A Amgen/UCB Osteoporosis July 2017

methylphenidate delayed and extended release

N/A Ironshore Pharmaceuticals/Highland Therapeutics

ADHD July 2017

ITCA 650 (exenatide mini-pump) N/A Intarcia Diabetes September 2017

oxycodone controlled-release Rexista™ Intellipharmaceuticals Pain, abuse deterrent September 2017

fluticasone furoate/umeclidinium/vilanterol

N/A GSK/Innoviva COPD September 2017

secnidazole Solosec™ Symbiomix Bacterial vaginosis September 2017

amphetamine XR N/A Neos Therapeutics ADHD September 2017

lesinurad/allopurinol Duzallo™ Ironwood Pharmaceuticals

Uncontrolled gout September 2017

Drug Pipeline > March 2017 Page 6

First generic approvals of top selling brand name drugs in the past twelve monthsGeneric Name Brand Name Brand Manufacturer Indication(s) Approval Date*

desvenlafaxine SR Pristiq® Pfizer Depression March 2016

methylphenidate ER Concerta® Janssen ADHD January 2016

oseltamivir phosphate capsules Tamiflu® Roche/Genetech Influenza December 2016

ezetimibe Zetia® Merck High cholesterol December 2016

olmesartan and olmesartan/HCTZ

Benicar®/ Benicar® HCT

Daiichi-Sankyo High blood pressure November 2016

quetiapine XR Seroquel XR® AstraZeneca Schizophrenia/bipolar disorder November 2016

rosuvastatin Crestor® AstraZeneca High cholesterol April 2016

* Date usually indicates FDA approval date. The product’s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market.

Other first generic launches in the past twelve monthsGeneric name Brand name Manufacturer Indication(s) Date approved*

prednisolone sodium phosphate oral solution 10 mg/5 mL

Millipred® Zylera Pharmaceuticals

Inflammatory conditions March 2017

prednisolone sodium phosphate oral solution 20 mg/5 mL

Veripred® 20 Zylera Pharmaceuticals

Inflammatory conditions March 2017

methylphenidate SR 60 mg Ritalin® LA Novartis ADHD March 2017

flurandrenolide oint Cordran® Aqua Pharmaceuticals

Skin irritation February 2017

lopinavir/ritonavir soln Kaletra® AbbVie HIV January 2017

aspirin/dipyridamole Aggrenox® Boehringer Ingelheim Reduce risk of stroke January 2017

dexmethylphenidate Focalin XR® Novartis ADHD January 2017

rasagiline Azilect® Teva Neuroscience Parkinson’s disease January 2017

aprepitant Emend® Merck/ Schering-Plough

Chemotherapy induced nausea/vomiting January 2017

epinephrine injection, USP auto-injection

Authorized generic of Epipen® and Epipen Jr®

Auto-Injector

Mylan Anaphylaxis December 2016

bimatoprost Latisse® Allergan Dermatologics

Eyelash growth December 2016

continued

Drug Pipeline > March 2017 Page 7

Generic name Brand name Manufacturer Indication(s) Date approved*

armodafinil Nuvigil® Cephalon Improve wakefulness in patients with excessive sleepiness associated with certain disorders

November 2016

fluoxetine tablets Sarafem® Actavis Premenstrual dysphoric disorder November 2016

olmesartan/amlodipine/hydrochlorothiazide

Tribenzor® Daiichi Sankyo Hypertension November 2016

amlodipine/olmesartan Azor® Daiichi Sankyo Hypertension November 2016

hydromorphone XR Exalgo® Mallinckrodt Brand Pharma

Pain October 2016

Yuvafem® (estradiol vaginal tab) Vagifem® Novo Nordisk Vaginitis October 2016

flurandrenolide lotion Cordran® Aqua Pharmaceuticals

Eczema October 2016

valganciclovir solution Valcyte® Genetech CMV September 2016

sumatriptan nasal spray, 5 mg/act and 20 mg/act

Imitrex® nasal spray Glaxo Smith Kline Migraine August 2016

ethacrynic acid Edecrin® Valeant Edema August 2016

nilutamide Nilandron® Concordia Pharmaceuticals/ Covis Pharmaceuticals

Metastatic prostate cancer July 2016

omeprazole/sodium bicarbonate Zegerid® powder pack for suspension

Valeant For treatment of duodenal ulcer, GERD July 2016

pramipexole ER Mirapex ER® 3.75 mg

Boehringer Ingelheim Parkinson’s disease July 2016

clindamycin phosphate/tretinoin Ziana® gel Valeant Acne July 2016

fenofibrate Fenoglide® Valeant High cholesterol July 2016

hydroxyprogesterone Makena® Amag and Lumara Reduce preterm birth June 2016

dofetilide Tikosyn® Pfizer Irregular heartbeats June 2016

armodafinil Nuvigil® Cephalon Improve wakefulness June 2016

doxycyline hyclate DR Doryx® Mayne Severe acne June 2016

miglitol Glyset® Pfizer Diabetes June 2016

hydrocodone-acetaminophen solution

Zamicet Beach Pain May 2016

benzphetamine Regimex® Wraser Pharmaceuticals

Weight loss May 2016

flurandrenolide cream Cordran® Aqua Pharmaceuticals

Skin irritation April 2016

* Date usually indicates FDA approval date. The product’s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market.

Other first generic launches in the past twelve months (continued)

Drug Pipeline > March 2017 Page 8

Generics of top selling brand drugs potentially available soon Generic Name Brand Name Brand Manufacturer Indication(s) To Market Date*

eletriptan Relpax® Pfizer Migraines 1Q2017

oseltamivir phosphate suspension

Tamiflu® Roche/Genetech Influenza February 2017

fluticasone/salmeterol Advair® GSK Asthma/COPD March 2017

ezetimibe/simvastatin Vytorin® Merck High cholesterol April 2017

atomoxetine Strattera® Eli Lily ADHD May 2017

sildenafil citrate Viagra Pfizer ED December 2017

glatiramer acetate 40 mg/mL Copaxone Teva Multiple sclerosis 2017 – 2018

* Expected to market dates are predictions made by Prime Therapeutics based on industry information.

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All brand names are property of their respective owners.