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 > December 2016 New drug information ● Synjardy ® XR (empagliflozin/metformin extended release): The U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Synjardy XR for the once-daily treatment of patients with type 2 diabetes. Synjardy ® (empagliflozin/metformin) has been available since 2015, but must be dosed twice daily. ● Eucrisa ™ (crisaborole): The FDA approved Pfizer/ Anacor’s Eucrisa ointment for the treatment of mild to moderate atopic dermatitis in patients aged two and older. Crisaborole is the first topical phosphodiesterase-4 inhibitor and is applied twice a day. Pfizer has projected crisaborole to have annual sales of $2 billion. 1 ● Epinephrine injection, USP Auto-Injector: Mylan has launched the authorized generic to EpiPen ® Auto- Injector. These self-injectable epinephrine devices are for people who have a history of or increased risk for a life-threatening allergic reaction (anaphylaxis). The product is available in two different dosages: 0.3 mg and 0.15 mg. An authorized generic and a brand name product are identical except the authorized generic does not bear the branded name. Mylan is launching the authorized generic product at a list price of $300 per two-pack carton, which is 50 percent less than the wholesale acquisition cost (WAC) for the branded product. 2 Generic drug information ● Nuvigil ® (armodafinil): Lupin has launched a generic version of Cephalon’s Nuvigil 200 mg tablet to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shiſt work disorder (SWD). An authorized generic version had previously been launched by Aurobindo Pharma in August 2016. According to IMS Health, annual sales for all strengths of Nuvigil were $515.6 million. ● Zetia ® (ezetimibe): Glenmark/Par has launched its generic version of Merck’s Zetia (ezetimibe) for high cholesterol. Zetia is an inhibitor of cholesterol absorption used alone or in combination with other cholesterol lowering agents such as statins. Glenmark/Par will have 180 days of marketing exclusivity. According to IMS in October, Zetia had approximately $2.3 billion in sales over the previous 12 months. ● Tamiflu ® (oseltamivir phosphate): Alvogen/Natco Pharma has launched its generic version of Roche/ Genentech’s Tamiflu (oseltamivir phosphate) capsules for the treatment of influenza. Lupin Pharmaceuticals may also launch their generic version of Tamiflu capsules, as well as the first generic Tamiflu suspension in February 2017. According to IMS Health, Tamiflu had approximately $403 million in sales for the 12 months ended in December 2015.
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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 > December 2016
New drug information ● Synjardy® XR (empagliflozin/metformin extended
release): The U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Synjardy XR for the once-daily treatment of patients with type 2 diabetes. Synjardy® (empagliflozin/metformin) has been available since 2015, but must be dosed twice daily.
● Eucrisa™ (crisaborole): The FDA approved Pfizer/Anacor’s Eucrisa ointment for the treatment of mild to moderate atopic dermatitis in patients aged two and older. Crisaborole is the first topical phosphodiesterase-4 inhibitor and is applied twice a day. Pfizer has projected crisaborole to have annual sales of $2 billion.1
● Epinephrine injection, USP Auto-Injector: Mylan has launched the authorized generic to EpiPen® Auto-Injector. These self-injectable epinephrine devices are for people who have a history of or increased risk for a life-threatening allergic reaction (anaphylaxis). The product is available in two different dosages: 0.3 mg and 0.15 mg. An authorized generic and a brand name product are identical except the authorized generic does not bear the branded name. Mylan is launching the authorized generic product at a list price of $300 per two-pack carton, which is 50 percent less than the wholesale acquisition cost (WAC) for the branded product.2
Generic drug information ● Nuvigil® (armodafinil): Lupin has launched a generic
version of Cephalon’s Nuvigil 200 mg tablet to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). An authorized generic version had previously been launched by Aurobindo Pharma in August 2016. According to IMS Health, annual sales for all strengths of Nuvigil were $515.6 million.
● Zetia® (ezetimibe): Glenmark/Par has launched its generic version of Merck’s Zetia (ezetimibe) for high cholesterol. Zetia is an inhibitor of cholesterol absorption used alone or in combination with other cholesterol lowering agents such as statins. Glenmark/ Par will have 180 days of marketing exclusivity. According to IMS in October, Zetia had approximately $2.3 billion in sales over the previous 12 months.
● Tamiflu® (oseltamivir phosphate): Alvogen/Natco Pharma has launched its generic version of Roche/Genentech’s Tamiflu (oseltamivir phosphate) capsules for the treatment of influenza. Lupin Pharmaceuticals may also launch their generic version of Tamiflu capsules, as well as the first generic Tamiflu suspension in February 2017. According to IMS Health, Tamiflu had approximately $403 million in sales for the 12 months ended in December 2015.
Drug Pipeline > December 2016 Page 2
● Latisse® (bimatoprost) solution: Sandoz has launched the first generic for Allergan’s Latisse for the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Apotex’s generic of Latisse is also approved, but the date of launch has not been announced. Annual sales for Latisse totaled $75 million for the 12 months ended in October, according to IMS health.
December news ● “The FDA approved a new indication for Jardiance®
(empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and cardiovascular disease. Jardiance was studied in a postmarket clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease. In the trial, Jardiance was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.”3
● “Global spending on prescription drugs will reach nearly $1.5 trillion by 2021, although the annual rate of growth will decrease from recent years, according to a forecast by Quintiles IMS Holdings. Spending in the United States is expected to account for more than half of global growth over the five-year period, at a compound annual rate of 6% to 9%, or 4% to 7% when discounts and rebates are considered.”4
● “Novo Nordisk announced the submission of a New Drug Application (NDA) to the FDA for semaglutide, a glucagon-like peptide-1 (GLP-1) analog administered once-weekly, for the treatment of adults with type 2 diabetes.”5
Drug Pipeline > December 2016 Page 3
New molecular entity approvals in the past 12 monthsGeneric name Brand name Manufacturer Indication(s) Date approved*
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
brivaracetam Briviact® UCB Seizure February 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*
Epinephrine injection, USP Auto‑injection
Authorized generic of Epipen® and Epipen Jr® Auto‑Injector
abaloparatide N/A Radius Health Osteoporosis March 2017
naldemedine N/A Shinonogi Opioid induced constipation March 2017
safinamide Xadago® Newron Pharmaceuticals
Parkinson’s disease March 2017
pharmaceutical grade L‑glutamine
N/A Emmaus Life Science Sickle cell disease March 2017
First generic approvals of top selling brand name drugs in the past twelve monthsGeneric Name Brand Name Brand Manufacturer Indication(s) Approval Date*
oseltamivir phosphate capsules Tamiflu® Roche/Genentech 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
mometasone nasal spray Nasonex® Merck Seasonal allergies March 2016
imatinib Gleevec® Novartis Cancer (multiple indications) February 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.
Drug Pipeline > December 2016 Page 6
continued
Other first generic launches in the past twelve monthsGeneric name Brand name Manufacturer Indication(s) Date approved*
bimatoprost Latisse® Allergan Dermatologics
Eyelash growth December 2016
armodafinil Nuvigil® Cephalon Improve wakefulness in patients with excessive sleepiness associated 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
omeprazole/sodium bicarbonate Zegerid® powder pack for suspension
Valeant Treatment of duodenal ulcer, gastroesophageal reflux disease
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
Dermatoses April 2016
diclofenac sodium gel, 1% Voltaren® Gel Endo Osteoarthritis March 2016
Drug Pipeline > December 2016 Page 7
Generic name Brand name Manufacturer Indication(s) Date approved*
frovatriptan Frova® Endo Migraine March 2016
zolpidem sublingual Intermezzo® Purdue Insomnia March 2016
darifenacin 24 hr SR Enablex® Actavis Overactive bladder March 2016
oxiconazole 1% cream Oxistat® cream Pharmaderm Fungal infection March 2016
cyclopentolate ophthalmic solution, 0.5%
Cyclogyl® 0.5% Alcon To produce mydriasis and cycloplegia March 2016
naftifine cream, 2% Naftin® Merz Pharmaceuticals
Fungal infection February 2016
metformin modified release 24hr SR
Glumetza® Valeant Diabetes February 2016
norgestimate/ethinyl estradiol Ortho Tri‑Cyclen Lo® Jannsen Contraceptive January 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)
Generics of top selling brand drugs potentially available soon Generic Name Brand Name Brand Manufacturer Indication(s) To Market Date*
eletriptan Relpax® Pfizer Migraines December 2016
sildenafil Viagra® Pfizer Erectile dysfunction Approved March 2016; launch anticipated December 2016
oseltamivir phosphate suspension
Tamiflu® Roche/Genentech Influenza February 2017
ezetimibe/simvastatin Vytorin® Merck High cholesterol April 2017
