Pipeline Report May 2020

Home , Isatuximab, Margetuximab, Remimazolam, Sacituzumab govitecan, Tafasitamab, Tanezumab

© 2020 Envolve. All rights reserved. Page 1 This quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug Information team to Table of Contents increase your understanding of the drug pipeline, ensuring you’re equipped with insights to prepare Recent Specialty Drug Approvals 1 for shifts in pharmacy benefit management. In this issue, you’ll learn more about these key themes and notable drugs: Recent Non-Specialty Drug Approvals 2

> Despite the FDA’s recent intense focus on COVID- 19-related activities, oncology drug pipeline is one Upcoming Specialty Products 3 therapeutic area which remains vibrant in the immediate term. This is evidenced by the consistent rate of FDA approvals, as well as acceptance of New Drug and Biologic License Applications for review. In fact, multiple oncology agents were Upcoming Non-Specialty Products 7 FDA-approved several months ahead of schedule, underscoring the urgency with which the FDA continues to act on oncologic agents. Biosimilars 9 > Several pipeline agents on this quarterly report are worth highlighting as possible new alternatives in high-cost disease states with few therapeutic options. These Generic Specialty Agents 10 agents include viltolarsen in the treatment of Duchenne muscular dystrophy (DMD), fostemsavir in the treatment of heavily treatment-experienced adult patients with HIV, and roxadustat which offers the first oral alternative to Generic Non-Specialty Agents 11 injectable agents such as Aranesp, Epogen and Procrit, for the treatment of anemia associated with chronic kidney disease.

To prepare this report, our team accesses a wide range of clinical resources. This information is then analyzed, resulting in updates across multiple disease states including recent and anticipated drug approvals, key changes in the biosimilar agent landscape, and notes on recent and anticipated generic product launches. Our pipeline report is just one of many ways we’re committed to providing helpful tools and resources to our clients and partners. We look forward to sharing more updates with you in the months ahead.

Ross Hoffman, MD

To provide comments, feedback or requests for report enhancements, please email us at [email protected]. Pipeline Report Recent Specialty Drug Approvals May 2020

FDA Approval AcariaHealth (AH) Cost (AWP Drug Name Manufacturer Indication(s) Comments Date Access Status Package Price) ENDOCRINOLOGY Isturisa • For the treatment of adults who either cannot undergo pituitary osilodrostat • Novartis • Cushing’s disease 3/6/2020 Pending launch gland surgery or have undergone the surgery but still have the $410,400/ year oral tablets disease. NEUROLOGY Vyepti • Alder • Efficacy demonstrated for both episodic and chronic migraines. eptinezumab-jjmr • Migraine headaches 2/21/2020 Limited access $7,176/ year BioPharmaceuticals • 30-minute infusion once every 12 weeks. intravenous infusion

Zeposia • Relapsing forms of multiple • Same mechanism of action as Gilenya, but potentially less cardiac ozanimod • Celgene 3/25/2020 Pending launch Pending launch sclerosis (MS) adverse effects. oral capsules ONCOLOGY Sarclisa • Proposed for use in combination with pomalidomide and isatuximab-irfc • Sanofi • Muliple myeloma 3/2/2020 Limited access dexamethasone for third-line treatment. $141,960/ year intravenous infusion • Same mechanism of action and indication as Darzalex.

Koselugo • Neurofibromatosis type 1 (NF1) • AstraZeneca • Approved for the treatment of pediatric patients aged two years and selumetinib with plexiform neurofibromas 4/10/2020 Limited access $156,960/ year • Merck older with symptomatic, inoperable PNs. oral capsules (PN) Jelmyto • Is the only FDA-approved non-surgical treatment for this indication, mitomycin • UroGen for the treatment of low-grade upper tract disease that is $363,392/ 14-month • Urothelial carcinoma 4/15/2020 Pending launch pyelocalyceal instillation Pharmaceuticals unamenable to endoscopic resection or with contraindication to course of therapy gel nephroureterectomy. Pemazyre • For the treatment of locally advanced/metastatic or surgically pemigatinib • Incyte • Cholangiocarcinoma 4/17/2020 Limited access unresectable disease with FGFR-2 translocation in patients who $285,600/ year oral tablets failed previous therapy.

• Approved for use in combination with trastuzumab and capecitabine Tukysa • Cascadian for patients who have received one or more prior anti-HER2-based tucatinib • Breast cancer 4/17/2020 AH has access $266,400/ year Therapeutics regimens in the metastatic setting. oral tablets • Showed efficacy in patients both with or without brain metastases.

Trodelvy • Antibody-drug conjugate (ADC). sacituzumab govitecan- • Triple negative breast cancer • Impressive clinical activity seen in a refractory setting. • Immunomedics 4/22/2020 Limited access $251,160/ year hziy (TNBC) • Is the first and only ADC approved for the treatment of metastatic intravenous infusion TNBC. • Approved for both first-line and previously treated patients with Tabrecta • Non-small cell lung cancer metastatic MET exon 14 skipping (METex14) mutated disease. capmatinib • Novartis 5/6/2020 Pending launch Pending launch (NSCLC) • The MET mutation is seen in an estimated 3% - 4% of all patients oral tablets with NSCLC.

FDA Approval Cost (AWP Package Drug Name Manufacturer Indication(s) Comments Date Price) CARDIOVASCULAR Nexletol • For use in combination with maximally tolerated statin therapy. • Esperion bempedoic acid • Hypercholesterolemia 2/21/2020 • Not as potent as Praluent and Repatha, but considerably less $4,818/ year Therapeutics, Inc. oral tablets expensive.

Nexlizet • For use in combination with maximally tolerated statin therapy. • Esperion bempedoic acid /ezetimibe • Hypercholesterolemia 2/26/2020 • Not as potent as Praluent and Repatha, but considerably less Pending launch Therapeutics, Inc. oral tablets expensive. GASTROINTESTINAL Pizensy • Chronic idiopathic • Once daily dosing. lactitol • Braintree labs 2/12/2020 Pending launch constipation • Mixed with 4-8 oz of fluid (water, juice, coffee, etc.). oral solution

Barhemsys • Post-operative nausea and amisulpride • Acacia 2/26/2020 • Approved for use as both treatment and prophylaxis. Pending launch vomiting intravenous infusion NEUROLOGY Nurtec ODT • Will compete with generically available oral triptans for the same rimegepant • Biohaven • Migraine headaches 2/27/2020 $12,240/ year indication. oral tablets

Ongentys • Once daily dosing. • Neurocrine opicapone • Parkinson’s disease (PD) 4/24/2020 • Intended as adjunct to levodopa therapy in patients experiencing “off” Pending launch Biosciences oral capsules episodes.

Anticipated Approval Drug Name Manufacturer Indication(s) Mechanism of Action Comments Date

CARDIOVASCULAR

• Potentially large impacted population. Revascor • Proposed for use in left ventricular systolic dysfunction. rexlemestrocel-L • Mesoblast • Chronic heart failure • Stem cell therapy 2020 • Would be reserved for use in patients who had failed multiple other intramyocardial injection therapies.

• Administered in the doctor’s office as twice yearly dosing. • Proprotein convertase subtilisin/ inclisiran • Would compete with the PCSK9 binding inhibitors for high • Novartis • Hypercholesterolemia kexin type 9 (PCSK9) synthesis 12/1/2020 subcutaneous injection cardiovascular risk patients who are already on maximized statin inhibitor therapy. COAGULATION DISORDERS Roctavian • Proposed for the treatment of adults with severe disease (~60% of the valoctocogene • BioMarin • Hemophilia A • Gene therapy total hemophilia A population). 8/21/2020 roxaparvovec • Current standard of care is factor VIII replacement therapy. intravenous infusion AMT-061 • For the treatment of adults with severe disease (~40% of the total etranacogene • Uniqure • Hemophilia B • Gene therapy hemophilia B population). 2020-2021 dezaparvovec • Current standard of care is factor IX replacement therapy. intravenous infusion • For the treatment of adults with severe disease (~60% of the total SPK-8011 • Spark • Hemophilia A • Gene therapy hemophilia A population). 2021 intravenous infusion • Roche • Current standard of care is factor VIII replacement therapy or Hemlibra.

ENDOCRINOLOGY

UX 007 • Currently available therapies include avoidance of fasting, low-fat/high • Long-chain fatty acid triheptanoin • Ultragenyx • Fatty acid replacement therapy carbohydrate diets, carnitine and medium-chain triglyceride (MCT) oil, 7/31/2020 oxidative disorder oral liquid a medical food product.

• Once daily oral therapy. BCX7353 • Hereditary angioedema • Selective inhibitor of plasma • All other HAE therapies are IV or SC injections. berotralstat • BioCryst 12/3/2020 (HAE) kallikrein • High demand for this more convenient, less invasive dosage form is oral capsules anticipated.

HEPATOLOGY

OCA • Non-alcoholic • Farnesoid X-activated receptor • New indication for Ocaliva. obeticholic acid • Intercept 6/26/2020 hepatosteatosis (NASH) agonist • Would be the first FDA-approved pharmacologic therapy for NASH. oral tablets

Anticipated Approval Drug Name Manufacturer Indication(s) Mechanism of Action Comments Date

IMMUOLOGY

• IV infusion twice weekly for 4 consecutive weeks. Ryoncil • Acute graft vs. host • Among 50 patients who received ≥ 1 treatment infusion, the Day 100 remestemcel-L • Mesoblast • Stem cell therapy 9/30/2020 disease mortality rate was 22%, in contrast to Day 100 mortality rates as high as intravenous infusion 70% in historical controls.

INFECTIOUS DISEASE

BMS663068 • Human immunodeficiency • Proposed for the treatment of heavily treatment-experienced adult fostemsavir • ViiV Healthcare • Viral attachment inhibitor 8/9/2020 virus (HIV) patients. oral tablets

MUSCULOSKELETAL CONDITIONS

RG7916 • Proposed for the treatment of SMA Types 1, 2, and 3. • PTC Therapeutics • Spinal muscular atrophy risdiplam • SMN2 gene splicer • Would be the first daily oral therapy approved for SMA. 8/24/2020 • Roche (SMA) oral therapy • Potential competitor to Spinraza and Zolgensma.

NS-065 • Duchenne muscular • Exon 53 skipping agent • Proposed for the treatment of DMD amenable to exon 53-skipping. viltolarsen • NS Pharma Q3 2020 dystrophy (DMD) • Antisense oligonucleotide • Would compete with Vyondys 53, with potentially better efficacy. intravenous infusion • Would compete with SRP-9001 gene therapy for those with mutations GALGT2 • Duchenne muscular between exons 18 and 58. AAVrh74.MHCK.GALGT2 • Sarepta • Gene therapy 2020-2021 dystrophy • SRP-9001 is further along in the pipeline process, but it’s too early to intra-arterial injection distinguish between the two agents’ relative safety and efficacy profiles. SRP-9001 • Duchenne muscular • Targets exons 18 through 58 (~60-75% of DMD patients have mutations microdystrophin • Sarepta • Gene therapy 2020-2021 dystrophy in these exons). intravenous infusion SGT-001 • Duchenne muscular • Development has been marred by safety issues and FDA-applied clinical • Solid Biosciences • Gene therapy 2021 intravenous infusion dystrophy trial holds, with thus far mediocre efficacy results.

NEPHROLOGY/HEMATOLOGY

• Proposed for use in both dialysis- and non-dialysis-dependent CKD. FG-4592 • AstraZeneca • Anemia of chronic kidney • Hypoxia-inducible factor prolyl • Would compete with erythropoietin stimulating agents (ESAs, e.g., roxadustat 12/20/2020 • Fibrogen disease hydroxylase inhibitor (HIF-PHI) Procrit, Aranesp). oral therapy • Appears to have less cardiovascular risk.

ONCOLOGY Instiladrin • Ferring • Non-muscle invasive • Proposed for BCG-refractory disease. nadofaragene firadenovec • Gene therapy 5/25/2020 Pharmaceuticals bladder cancer • Treatment is applied once every 12 weeks. intravesical injection

Anticipated Approval Drug Name Manufacturer Indication(s) Mechanism of Action Comments Date

bb2121 • Similar proposed indication as, but apparently less robust efficacy than, • bluebird bio • B-cell maturation antigen (BCMA)- idecabtagene vicleucel • Multiple myeloma JNJ-68284528, which demonstrated a 100% overall response rate in the 2nd Half of 2020 • Bristol-Myers Squibb targeted CAR-T cell therapy intravenous infusion CARTITUDE-1 trial.

GSK2857916 • Proposed as monotherapy in patients who have failed at least three • Anti-B cell maturation antigen belantamab mafodotin • GlaxoSmithKline • Multiple myeloma prior lines of therapy, including an anti-CD38 antibody and are 7/21/2020 (BCMA) monoclonal antibody intravenous infusion refractory to a proteasome inhibitor and an immunomodulatory agent. • Proposed for the treatment of relapsed/refractory disease after at least KTE-X19 five prior therapies. • Gilead • Mantle cell lymphoma • CAR-T therapy 8/10/2020 intravenous infusion • Demonstrated an overall response rate of 93%, including 67% with complete response.

• Proposed for the initial treatment of intermediate- and high-risk MDS • Cedazuridine ASTX727 including including chronic myelomonocytic leukemia. • Astex • Myelodysplastic syndrome • Cytidine deaminase inhibitor cedazuridine + decitabine • Allows for oral delivery of decitabine at exposures which emulate 8/11/2020 Pharmaceuticals (MDS) • Decitabine: DNA hypomethylating oral therapy exposures achieved with the IV form (Dacogen) administered over 5 agent days.

DCC-2619 • Gastrointestinal stromal • Proposed as fourth-line treatment of patients who have received prior ripretinib • Deciphera • Pan-KIT and PDGFRα inhibitor 8/13/2020 tumor (GIST) treatment with imatinib, sunitinib and regorafenib. oral tablets

Zepsyre • Proposed for the treatment of patients whose disease has progressed lurbinectedin • PharmaMar • Small cell lung cancer • RNA polymerase II inhibitor 8/16/2020 after prior platinum-containing therapy. intravenous infusion

MGAH22 • Proposed for the treatment of HER2-positive metastatic disease, in margetuximab • MacroGenics • Breast cancer • Anti-HER2 monoclonal antibody combination with chemotherapy. 8/19/2020 intravenous infusion • Same mechanism of action as Herceptin.

MOR208 • Proposed for use in combination with lenalidomide for the treatment of • Diffuse large B-cell • Fc-enhanced anti-CD19 tafasitamab • MorphoSys adult patients with relapsed/refractory disease who are not eligible for 8/30/2020 lymphoma (DLBCL) monoclonal antibody intravenous infusion high-dose chemotherapy and autologous stem-cell transplantation.

Rolontis • Spectrum • Chemotherapy-induced • Long-acting agent dosed every 3 weeks. eflapegrastim • Colony stimulating factor 10/24/2020 Pharmaceuticals neutropenia • Demonstrated non-inferiority to Neulasta. subcutaneous injection

JCAR017 • Chimeric antigen receptor T-cell • Would be third to market after Kymriah and Yescarta for this indication. lisocabtagene maraleucel • Juno Therapeutics • Non-Hodgkin’s lymphoma 11/16/2020 (CART) therapy • Has demonstrated a relatively favorable adverse effect profile. intravenous infusion • Proposed for the treatment of relapsed/refractory disease after at least JNJ-68284528 three prior lines of therapy. • Janssen • Multiple myeloma • Anti-BCMA CAR-T therapy 2020 intravenous infusion • Demonstrated a 100% overall response rate in the Phase I/II CARTITUDE-1 trial.

Anticipated Approval Drug Name Manufacturer Indication(s) Mechanism of Action Comments Date Ad-RTS-hIL-12/ • Current standard of care is surgery, followed by radiation and veledimex chemotherapy (usually with temozolomide). • Ziopharm Oncology • Recurrent glioblastoma • Gene therapy + oral activator agent 2021-2022 intratumoral injection + oral • Would potentially be used after resection and radiation+temozolomide therapy if progression or recurrence. OPHTHALMOLOGY

RG6168 • Neuromyelitis optica • Demonstrated benefit in both AQP4-positive and negative subjects. • Anti-interleukin-6 receptor satralizumab • Genentech and neuromyelitis optica • Administered as a monthly subcutaneous injection after an initial 5/31/2020 antibody subcutaneous injection spectrum disorders loading phase.

MEDI551 • Neuromyelitis optica • MedImmune • Would compete with Soliris. inebilizumab and neuromyelitis optica • Anti-CD19 monoclonal antibody 6/11/2020 • AstraZeneca • Ultomiris is also being studied for the same indication. intravenous infusion spectrum disorders

MP0112 • Age-related macular • Vascular endothelial growth factor • In two phase III trials, treatment with abicipar pegol given every 8 or 12 abicipar pegol • Allergan 7/9/2020 degeneration (VEGF) inhibitor weeks was non-inferior to Lucentis given every 4 weeks. intraocular injection NSR-REP1 • Confirmation of diagnosis will be key, as clinical presentation of this • Nightstar • Choroideremia • Gene therapy 2020-2021 subretinal injection disease is similar to other conditions.

Anticipated Approval Drug Name Manufacturer Indication(s) Mechanism of Action Comments Date ANESTHESIA CNS7056 remimazolam • Paion • Sedation during gastrointestinal procedures • Benzodiazepine derivative • Rapid-acting, short-duration sedative. 7/5/2020 intravenous infusion DERMATOLOGY VP-102 • Current therapies in use include cryotherapy, • Verrica cantharidin • Molluscum contagiosum • Vesicant and irritant scraping or cantharidin obtained by provider 7/13/2020 Pharmaceuticals topical solution offices from outside sources.

Winlevi • Unlike oral hormonal therapies for acne, this clascoterone • Cassiopea • Acne vulgaris • Dihydrotesterone antagonist therapy may be used in both male and female 8/27/2020 topical cream patients. KX2-391 • Src kinase inhibition tirbanibulin • Athenex, Inc. • Actinic keratosis • Five-day course of therapy. 12/30/2020 topical ointment • Tubulin polymerization inhibition

IMMUNOLOGY • Proposed for treatment of children 4-11 years Viaskin Peanut old. peanut antigen • DBV Technologies • Peanut hypersensitivity • Epicutaneous desensitization therapy 8/5/2020 • Once daily patch. transdermal patch • Would compete with Palforzia. KIDNEY DISEASE TRC101 • Metabolic acidosis in patients with chronic • Non-absorbable hydrochloride-binding • Currently there are no FDA-approved chronic veverimer • Tricida 8/22/2020 kidney disease (CKD) polymer agent therapies for treating metabolic acidosis. oral suspension MUSCULOSKELETAL RN624 • Subcutaneous administration by a health care tanezumab • Pfizer • Osteoarthritis • Nerve growth factor (NGF) inhibitor 12/1/2020 provider once every eight weeks. subcutaneous injection NEUROLOGY

• Fintepla will likely be used as an adjunct to Fintepla existing therapies such as off-label valproate fenfluramine • Zogenix • Dravet syndrome • Central serotonin enhancing agent 6/25/2020 and clobazam (Onfi). oral solution • Epidiolex is also FDA-approved.

Qutenza • Averitas capsaicin • Diabetic peripheral neuropathy • Substance P depletion • 8% topical patch. 7/13/2020 Pharmaceuticals topical patch

Anticipated Approval Drug Name Manufacturer Indication(s) Mechanism of Action Comments Date ONCOLOGY • Proposed for the prevention of ototoxicity Pedmark • Fennec induced by cisplatin chemotherapy in patients sodium thiosulfate • Chemotherapy-induced ototoxicity • Antidote 8/10/2020 Pharmaceuticals 1 month to < 18 years of age with localized, non- intravenous infusion metastatic, solid tumors. OPHTHALMOLOGY RVL-1201 • Vertical • Once-daily ophthalmic formulation. oxymetazoline • Blepharoptosis • Alpha-adrenergic receptor agonist 7/16/2020 Pharmaceuticals • Standard of care is surgery for severe cases. ophthalmic solution PSYCHIATRY SEP289 • Dopamine and norepinephrine reuptake • Once-daily dosing. dasotraline • Sunovion • Binge eating disorder 5/14/2020 inhibitor • Same indication as Vyvanse. oral tablet

SPN-812 • Supernus • Attention deficit hyperactivity disorder • Serotonin norepinephrine modulating • Multiple other therapies for ADHD already viloxazine 11/8/2020 Pharmaceuticals (ADHD) agent (SNMA) exist. oral therapy • Compared to traditional anti-depressants, LY03005 • Serotonin-norepinephrine-dopamine triple SNDRI is proposed to help preserve patients’ ansofaxine • Luye Pharma Group • Major depressive disorder 12/26/2020 reuptake inhibitor (SNDRI) sexual function and produce a more rapid oral tablets onset with higher efficacy. UROLOGY

• Once daily oral therapy. MK-4618 • Proposed for the treatment of patients with vibegron • Urovant Sciences • Overactive bladder • β 3-adrenergic agonist 12/26/2020 symptoms of urge urinary incontinence, oral therapy urgency and urinary frequency.

WOMEN’S HEALTH Amphora L-lactic acid, citric acid, • Maintains an acidic vaginal environment that is • Evofem • Pregnancy prevention • Spermicide 5/25/2020 and potassium bitartrate inhospitable to sperm. topical therapy

Biosimilar Status/Estimated Biosimilar Currently Drug Name Manufacturer Indication(s) Comments Reference Drug Approval Launched?

ENDOCRINOLOGY Basalog BLA is under FDA • Mylan insulin glargine Lantus • Diabetes mellitus review (BsUFA date: Yes - Basaglar, Toujeo • Biosimilar to Lantus. • Biocon subcutaneous injection 6/1/2020) IMMUNOLOGY ABP 798 BLA is under FDA • Amgen • Another biosimilar to Rituxan, after Ruxience, rituximab Rituxan • Rheumatoid arthritis review (BsUFA date: Yes - Ruxience, Truxima • Allergan Truxima. intravenous infusion 12/19/2020) ONCOLOGY PF-06881894 BLA is under FDA pegfilgrastim • Pfizer Neulasta • Chemotherapy-induced neutropenia review (BsUFA date: Yes - Fulphila • Biosimilar to Neulasta. subcutaneous injection 6/1/2020)

SB8 • Samsung BLA is under FDA • Another biosimilar to Avastin, after Mvasi, bevacizumab Bioepis Avastin • Breast cancer review (BsUFA date: Yes - Mvasi, Zirabev Zirabev. intravenous infusion • Merck 9/19/2020)

MYL-0401O BLA is under FDA • Mylan • Another biosimilar to Avastin, after Mvasi, bevacizumab Avastin • Breast cancer review (BsUFA date: Yes - Mvasi, Zirabev • Biocon Zirabev. intravenous infusion 12/27/2020)

Recent Approvals GENERIC NAME BRAND NAME MANUFACTURER(S) MARKET LAUNCH DATE naloxone hydrochloride Evzio • IJ Therapeutics 1/13/2020 ziprasidone mesylate Geodon (injection) • Gland Pharma 3/9/2020 everolimus Zortress • Hikma 3/13/2020 Pipeline Agents GENERIC NAME BRAND NAME MANUFACTURER(S) ANTICIPATED LAUNCH DATE • Par tolvaptan Samsca 2020 • Endo abiraterone acetate Zytiga (500 mg) • Teva 2020

thalidomide Thalomid • Hikma, Lannett 2020

emtricitabine/tenofovir disoproxil fumarate Truvada • Teva 9/30/2020 efavirenz/emtricitabine/tenofovir disoproxil fumarate Atripla • Teva 9/30/2020 • Par sapropterin dihydrochloride Kuvan 10/1/2020 • Endo • Graviti Pharmaceuticals • Macleods Pharmaceuticals dimethyl fumarate Tecfidera • Mylan 2020-2021 • Sandoz • Teva sunitinib Sutent • Mylan 8/16/2021

Recent Approvals GENERIC NAME BRAND NAME MANUFACTURER(S) MARKET LAUNCH DATE dapsone Aczone 7.5% • Taro 1/2/2020 budesonide/ formoterol fumarate dihydrate Symbicort • Prasco 1/6/2020 calcipotriene Sorilux • Ayurax 1/17/2020 betamethasone dipropionate/ calcipotriene Taclonex (topical suspension) • Prasco 1/22/2020 hydrocodone bitartrate Zohydro ER • Alvogen 1/22/2020 Indomethacin Tivorbex • Ayurax 2/4/2020 ketorolac tromethamine Sprix • Prasco 2/7/2020 moxifloxacin hydrochloride Moxeza • Lupin 2/14/2020 esomeprazole magnesium/ naproxen Vimovo • Dr. Reddy’s 2/27/2020 azelastine/ fluticasone propionate Dymista • Apotex 3/2/2020 esomeprazole magnesium Nexium (packets for oral suspension) • Cipla 3/24/2020 Pipeline Agents GENERIC NAME BRAND NAME MANUFACTURER ANTICIPATED LAUNCH DATE • Actavis methylphenidate Aptensio XR 2020 • Teva • Apotex • Dr. Reddy’s icosapent ethyl Vascepa 2020 • Teva • West-Ward/Hikma • Sandoz • Wockhardt acetaminophen Ofirmev 12/6/2020 • Aurobindo • Custopharm • Dr. Reddy’s • Sun lubiprostone Amitiza (24 mcg capsule) 1/1/2021 • Teva • Zydus nebivolol hydrochloride Bystolic • Hetero 9/17/2021

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