Drug Pipeline Monthly Update
Critical updates in an ever changing environment
March 2018
New drug information
●● Apadaz™ (benzhydrocodone/acetaminophen): KemPharm received Food and Drug Administration (FDA) approval for Apadaz for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Benzhydrocodone is a prodrug of the opioid agonist hydrocodone. KemPharm originally applied for an abuse-deterrent indication, the final approved product labelling does not include abuse-deterrent labeling as the results did not demonstrate abuse-deterrence by current measurement standards. Apadaz was scheduled as a CII, a drug that has the potential to be abused.
●● ZTlido ™ (lidocaine topical system): Sorrento Therapeutics received FDA approval for ZTlido for the relief of pain associated with post-herpetic neuralgia also known as post-shingles pain. Up to three patches may be applied to the skin to cover the most painful area for up to 12 hours in a 24-hour period. Compared with one Lidoderm® (lidocaine patch 5%, 700 mg), one ZTlido (1.8%, 36mg) provides equivalent lidocaine exposure due to a non-aqueous adhesive material.1
●● Symfi Lo™ (efavirenz [EFV], lamivudine [3TC], and tenofovir disoproxil fumarate [TDF]): The FDA approved Mylan’s Symfi Lo as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Symfi Lo contains 400 mg of EFV, 300 mg of 3TC, and 300 mg of TDF. Symfi Lo provides a complete regimen with a lower dose of efavirenz than Gilead’s Atripla® (600 mg EFV, 200 mg emtricitabine, and 300 mg TDF). Launch is expected in March or April 2018.2 Mylan plans to discount Symfi Lo’s wholesale acquisition cost (WAC) significantly from the WAC of other single tablet regimens available in the United States.3
●● Cimduo ™ (lamivudine/TDF): Mylan also received approval for Cimduo, a 2-drug combination of 3TC and TDF to be used in combination with other antiretroviral agents for the treatment of HIV-1 infection. CimDuo is expected to launch in the second quarter of 2018.2 Mylan will set Cimduo’s WAC at a significant discount compared to other tenofovir-based double combination products available in the US.3
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 Monthly Update: March 2018 Page 2
Generic drug information
●● Namenda XR® (memantine ER): Mylan, Par Pharma, Amneal Pharmaceuticals, and Lupin Pharmaceuticals launched their generic versions of Allergan’s Namenda XR for the treatment of Alzheimer’s disease. According to IMS data, Namenda XR had $929 million in annual sales in the U.S.
●● Solodyn® (minocycline ER): Both Teva and Impax Generics launched their generic versions of Valeant’s Solodyn in the strengths of 65 mg and 115 mg for the treatment of acne. Generic versions of the 55 mg, 80 mg, and 105 mg are expected in February 2019. According to IMS data, Solodyn had $148 million in annual sales in the U.S.
●● Ritalin LA® (methylphenidate LA): Sandoz and Mayne Pharma launched their generic versions of Novartis’ Ritalin LA 10 mg capsule. This is the first generic for Ritalin LA 10 mg, generic versions of other strengths have already been launched.
●● Gabitril® (tiagabine 12 mg, 16 mg): Amneal launched their generic version for Cephalon’s Gabitril tablets for the adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. Generic versions of other strengths have already been launched. No patents or exclusivities remain. Drug Pipeline Monthly Update: March 2018 Page 3
New molecular entity approvals in the past twelve months
Generic name Brand name Manufacturer Indication(s) Date approved* benzhydrocodone/ Apadaz™ KemPharm Pain March 2018 acetaminophen bictegravir/ Biktarvy™ Gilead HIV February 2018 emtricitabine/ tenofovir alafenamide ertugliflozin Steglatro™ Merck/Pfizer Diabetes December 2017
ozenoxacin Xepi™ Medimetriks Impetigo December 2017
netarsudil Rhopressa® Aerie Glaucoma or ocular hypertension December 2017 Pharmaceuticals semaglutide Ozempic™ Novo Nordisk Diabetes December 2017
letermovir Prevymis™ Merck Prophylaxis of CMV infection and disease November 2017
secnidazole Solosec™ Symbiomix Bacterial vaginosis October 2017
benznidazole Benznidazole™ Chemo Research/ Chagas disease August 2017 Tablets DNDi/Mundo Sano betrixaban Bevyxxa™ Portola Prophylaxis of venous thromboembolism July 2017
delafloxacin Baxdela™ Melinta Skin infections June 2017
*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 twelve months
Generic name Brand name Manufacturer Indication(s) Date approved* efavirenz, lamivudine, tenofovir Symfi Lo™ Mylan HIV March 2018 disoproxil fumarate lamivudine, tenofovir disoproxil Cimduo™ Mylan HIV March 2018 fumarate lidocaine topical system 1.8% ZTlido™ Sorrento Pain associated with post-herpetic March 2018 Therapeutics neuralgia (PHN) amantadine extended-release Osmolex ER™ Osmotica Parkinson’s disease and drug-induced February 2018 Pharmaceutical extrapyramidal symptoms ertugliflozin/metformin Segluromet™ Merck/Pfizer Diabetes December 2017
ertugliflozin/sitagliptin Steglujan™ Merck/Pfizer Diabetes December 2017
mometasone furoate Sinuva™ Intersect ENT, Inc Recurrent nasal polyps December 2017
glycopyrrolate Lonhala™ Sunovion COPD December 2017 Magnair™ Pharmaceuticals dolutegravir/rilpivirine Juluca™ Viiv Healthcare HIV-1 infection December 2017
sodium hyaluronate TriVisc™ OrthogenRx, Inc Osteoarthritis November 2017
aprepitant Cinvanti™ Heron Therapeutics Chemotherapy-induced nausea and November 2017 vomiting
continued Drug Pipeline Monthly Update: March 2018 Page 4
Other new product approvals in the past 12 months (continued)
Generic name Brand name Manufacturer Indication(s) Date approved* aripiprazole with sensor Abilify® MyCite™ Otsuka Drug-device combo for schizophrenia, November 2017 bipolar disorder and major depression latanoprostene bunod Vyzulta® Valeant Glaucoma or ocular hypertension November 2017 Pharmaceuticals pregabalin extended-release Lyrica® CR Pfizer Neuropathic pain October 2017
rolapitant Varubi™ Tesara/Opko Health Chemotherapy-induced nausea and October 2017 vomiting exenatide extended-release Bydureon® BCise™ AstraZeneca Diabetes October 2017
insulin aspart FIAsp™ Novo Nordisk Diabetes October 2017
fluticasone propionate nasal Xhance™ Optinose US, Inc Nasal polyps October 2017 spray fluticasone furoate, Trelegy™ Ellipta® GSK/Innoviva COPD September 2017 umeclidinium, vilanterol amphetamine extended-release Adzenys™ ER Neos Therapeutics ADHD September 2017 suspension spironolactone suspension CaroSpir™ CMP Pharma Cardiovascular August 2017
insulin lispro Admelog® Sanofi Diabetes September 2017 (full approval December 2017) lesinurad/allopurinol Duzallo™ Ironwood Uncontrolled gout August 2017 Pharmaceuticals pitavastatin sodium Nikita™ Lupin High cholesterol August 2017
beclomethasone dipropionate Qvar® RediHaler™ Teva Asthma August 2017
insulin glargine Lusduna® Nexvue™ Merck Diabetes August 2017
methylphenidate Cotempla™ XR-ODT Neos Therapeutics ADHD July 2017 extended‑release orally disintegrating tablets mixed salts of a single-entity Mydayis™ Shire ADHD July 2017 amphetamine products pitavastatin Zypitamag™ Zydus High cholesterol July 2017
epinephrine injection Symjepi™ Adamis Allergic reactions June 2017 Pharmaceuticals Corporation cetirizine ophthalmic solution Zerviate™ Nicox Ophthalmic Eye itching May 2017
methotrexate solution Xatmep™ Silvergate ALL and arthritis in pediatric patients April 2017 Pharmaceuticals oxycodone, immediate-release RoxyBond™ Inspirion/ Pain with abuse-deterrent properties April 2017 Daiichi Sankyo *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline Monthly Update: March 2018 Page 5
Pipeline watch Anticipated FDA Generic Name Brand Name Manufacturer Indication(s) Decision Date acetaminophen/ibuprofen Maxigesic® AFT Pharmaceuticals Pain December 2017
testosterone undecanoate Jatenzo™ Clarus Therapeutics Testosterone replacement December 2017
promethazine/hydrocodone/ Hydexor™ Charleston Labs Pain and opioid-induced nausea and April 2018 acetaminophen vomiting levodopa inhalation powder Inbrija™ Acorda Therapeutics Off symptoms of Parkinson’s disease April 2018
elagolix N/A Abbvie Inc./ Pain associated with endometriosis May 2018 Neurocrine Biosciences andexanet alfa AndexXa™ Portola Anticoagulant reversal agent May 2018
testosterone undecanoate Tlando™ Testosterone Lipocine May 2018 replacement polyethylene glycol and Plenvu™ Salix and Norgine Bowel cleansing May 2018 ascorbate botulinum toxin type A Evosyal™ Evolus/Daewoong Frown lines May 2018
vaginal estradiol Yuvvexy™ TherapeuticsMD Menopause May 2018
celecoxib/amlodipine Consensi™ Kitov Pharma Osteoarthritis pain/hypertension May 2018
lofexidine N/A US WorldMeds Opioid use disorder May 2018
moxidectin N/A Medicines River blindness June 2018 Development for Global Health plazomicin N/A Achaogen Bacterial infection June 2018
tafenoquine N/A 60 Degrees Prevention of malaria June 2018 Pharmaceuticals and USMMDA glycopyrronium tosylate N/A Dermira Excessive sweating June 2018
halobetasol propionate/ Duobril™ Ortho Dermatologic/ Plaque psoriasis June 2018 tazarotene Valeant aripiprazole lauroxil NanoCrystal N/A Alkermes Schizophrenia, bipolar disorder and June 2018 Dispersion (ALNCD) major depression risperidone N/A Indivior Schizophrenia July 2018
buprenorphine SL spray N/A Insys Therapeutics Acute pain July 2018
cyclosporine A ophthalmic N/A Sun Pharma Dry eye disease August 2018 solution oxycodone, controlled-release Remoxy ER™ Pain Therapeutics Pain, abuse deterrent August 2018 and Durect tecovirimat Tpoxx™ Siga Technologies Smallpox August 2018
ulipristal acetate Esmya™ Allergan Abnormal bleeding with uterine fibroids August 2018
loteprednol etabonate Inveltys™ Kala Pharmaceuticals Inflammation/pain with ocular surgery August 2018
tretinoin lotion Altreno™ Ortho Dermatologics Acne August 2018 (Valeant) eravacycline N/A Tetraphase Pharma Infection August 2018
dasotraline N/A Sunovion ADHD August 2018
clobazam OSF N/A Aquestive Lennox-Gastaut syndrome September 2018 Therapeutics Drug Pipeline Monthly Update: March 2018 Page 6
First generic approvals of top selling brand name drugs in the past twelve months
Generic name Brand name Manufacturer Indication(s) Date approved* memantine ER Namenda® XR Allergan Alzheimer’s disease March 2018
estradiol vaginal cream Estrace® Allergan Menopause symptoms January 2017
tenofovir disoproxil fumarate, Viread® 300 mg Teva HIV December 2017 300 mg sildenafil citrate Viagra® Pfizer Erectile dysfunction December 2017
glatiramer acetate Copaxone® Teva Neuroscience Multiple sclerosis October 2017
prasugrel Effient® Eli Lilly/ Reduction of CV events August 2017 Daiichi Sankyo eletriptan Relpax® Pfizer Migraine August 2017
mesalamine delayed release Lialda® Zydus Ulcerative colitis August 2017
moxifloxacin ophthalmic solution Vigamox® Apotex Eye infection July 2017
testosterone topical transdermal Axiron® Lilly Testosterone replacement July 2017 solution atomoxetine Strattera® Eli Lilly ADHD June 2017
ezetimibe/simvastatin Vytorin® Merck/ High cholesterol May 2017 Schering-Plough *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
Generic name Brand name Manufacturer Indication(s) Date approved* tiagabine 12 mg, 16 mg Gabitril® Cephalon Seizures March 2018
methylphenidate, 10 mg capsule Ritalin LA® Novartis ADHD March 2018
minocycline ER Solodyn® Valeant Acne March 2018
sumatriptan/naproxen Treximet® Aurobindo Pharma Migraine February 2018 85 mg – 500 mg hydrocortisone butyrate Locoid® Lotion Valeant Atopic dermatitis February 2018
trientine Syprine® Valeant Wilson’s disease February 2018
efavirenz 600 mg Sustiva® BMS HIV February 2018
atazanavir Reyataz® BMS HIV January 2018
carbinoxamine maleate Palgic® Alfasigma USA Allergies and cold January 2018
efavirenz, 50 mg and 200 mg Sustiva® BMS HIV January 2018
timolol maleate ophth solution Istalol® Valeant Glaucoma December 2017
pramoxine/hydrocortisone Novacort® gel 1–2% Novum Pharma Skin irritation December 2017
continued Drug Pipeline Monthly Update: March 2018 Page 7
Other first generic launches in the past twelve months (continued)
Generic name Brand name Manufacturer Indication(s) Date approved* fluoxetine tab, 60 mg Fluoxetine® Almatica Major depressive disorder, obsessive November 2017 compulsive disorder, bulimia nervosa, panic disorder dapsone gel, 5% Aczone® Allergan Acne November 2017
oseltamivir suspension Tamiflu® Genentech Influenza November 2017
carvedilol ER Coreg® CR GSK Cardiovascular November 2017
testosterone gel Testim® 1% Endo Testosterone replacement October 2017 Pharmaceuticals abacavir solution Ziagen® Viiv Healthcare HIV October 2017
sodium phenylbutyrate Buphenyl® Horizon Pharma Urea cycle disorders October 2017
paroxetine mesylate Brisdelle® Sebela VMS with menopause October 2017 Pharmaceuticals fosamprenavir Lexiva® Viiv Healthcare HIV October 2017
adapalene/benzoyl peroxide Epiduo® Galderma Acne August 2017
scopolamine Transderm-Scop® Sandoz, Baxter Motion sickness August 2017 Healthcare, Glaxo Consumer Healthcare sevelamer carbonate Renvela® Genzyme Control serum phosphorus August 2017
melphalan Alkeran® Apo Pharma Multiple myeloma/ July 2017 epithelial carcinoma of the ovary olopatadine solution Pataday® Teva Eye itching June 2017
thyroid tab Armour Thyroid® Actavis Hypothyroid June 2017
desoximetasone ointment Topicort® Taro Skin conditions May 2017
tazarotene cream Tazorac® Allergan Plaque psoriasis and acne April 2017
levonorgestrel/ethinyl estradiol Quartette® Teva Pregnancy prevention April 2017
venlafaxine extended-release Venlafaxine ER® UCB Pharma/Vertical Depression and anxiety April 2017 Pharmaceuticals zileuton extended-release Zyflo CR® Chiesi USA Asthma April 2017
*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 Monthly Update: March 2018 Page 8
Generics of top selling brand drugs potentially available soon
Generic name Brand name Manufacturer Indication(s) To market date* cinacalcet Sensipar® Amgen Hyperparathyroidism March 2018
ethinyl estradiol/etonogestrel NuvaRing® Organon/Merck & Co Pregnancy prevention April 2018
paliperidone palmitate, IM Invega Trinza® Janssen Schizophrenia May 2018
tadalafil Adcirca® Eli Lilly Pulmonary arterial hypertension (PAH) May 2018
treprostinil Remodulin® United Therapeutics PAH June 2018
ascorbic acid; PEG; potassium Moviprep® Salix Valeant Osmotic laxative September 2018 chloride; sodium ascorbate; sodium chloride; sodium sulfate tadalafil Cialis® Eli Lilly Erectile dysfunction September 2018
cyclosporine Restasis® Allergan Dry eye 2Q2018
vardenafil Levitra® Bayer Erectile dysfunction 3Q2018
tenofovir disoproxil fumarate Viread® Gilead HIV/HBV 1H2018 150 mg, 200 mg, 250 mg hydroxyprogesterone caproate Makena® (vial) AMAG Reduce the risk of preterm birth 1H2018 Pharmaceuticals everolimus Zortress® Novaris Post transplantation prophylaxis 1H2018
buprenorphine Butrans® Purdue Pain 2018
exenatide Byetta® AstraZeneca Diabetes 2018
testosterone Androgel® (1.62%) AbbVie Testosterone replacement 2018
loteprednol Lotemax® Bausch + Lomb/ Eye inflammation 2018 Valeant difluprednate Durezol® Alcon/Novartis Eye inflammation 2018
ganirelix acetate Ganirelix® Organon/Merck & Co Infertility 2018
epinephrine EpiPen® Merck Anaphylaxis 2018
albuterol sulfate Proventil® HFA/ Merck/Teva Asthma/COPD 2018 – 2019 ProAir® HFA fluticasone/salmeterol Advair® Diskus GSK Asthma/COPD 2018 – 2019
* Expected to market dates are predictions made by Prime based on industry information.
References 1. https://www.empr.com/news/ztlido-lidocaine-patch-postherpetic-neuralgia-treatment/article/747446/. 2. https://www.empr.com/news/symfi-lo-cimduo-hiv-treatments-mylan-lamivudine-tenofovir-efavirenz/article/748172/. 3. http://newsroom.mylan.com/2018-03-02-Mylan-to-Introduce-Two-New-Cost-Saving-HIV-Combination-Treatments-in-the-U-S.
All brand names are property of their respective owners.
2992-A1 © Prime Therapeutics LLC 03/18