Traditional Drug Pipeline Update: March 2022

Critical updates in an ever changing environment

March 29, 2022

New drugs, new indications and news of note

This monthly pipeline wrap up provides a review of newly approved traditional drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process. See separate article for pipeline information on specialty drugs.

New Drug Information

Norliqva™ (amlodipine besylate): The U.S. Food and Drug Administration (FDA) has approved CMP Pharma’s Norliqva (amlodipine besylate) an oral solution formulation of the approved calcium channel blocker amlodipine for the treatment of hypertension in adults and children six years and older, to lower blood pressure and coronary artery disease [chronic stable angina, vasospastic angina (Prinzmetal’s or variant angina) and angiographically documented coronary artery disease in patients without heart failure or an ejection fraction <40%.] Norliqva was approved via the 505(b)(2) pathway using Pfizer’s Norvasc (amlodipine oral tablets) as a reference product.1 Norliqva is supplied as a peppermint flavored oral solution containing 1mg/mL amlodipine as the besylate salt. It is administered once daily. Amlodipine is also available as an oral suspension in Azurity’s Katerzia. Norliqva launch and price are pending.

Generic Drug Information

Revlimid®+ (lenalidomide) 5, 10, 15, 25mg: Teva has launched their generic version of Bristol-Myers Squibb’s Revlimid 5, 10, 15, 25mg tablets. Revlimid is a thalidomide analogue indicated for the treatment of patients with:

    • Multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy
    • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities
    • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib

Teva is eligible for 180-day exclusivity for those four strengths. Thirteen more manufacturers are scheduled to launch in August of 2022. Revlimid 5,10, 15, 25mg generated $10,054 million in U.S. annual sales in 2021.

Apokyn®+ (apomorphine inj 30mg/3mL): TruPharma launched their version of Supernus Pharmaceuticals’ Apokyn for the treatment of Parkinson’s disease. Apokyn generated $69 million in U.S. annual sales in 2021.

+Specialty medication

NEW MOLECULAR ENTITY APPROVALS IN THE PAST TWELVE MONTHS
Generic Name Brand Name Manufacturer Indication(s) Date Approved*
daridorexant Quviviq® Idorsia Insomnia January 2022
maribavir Livtencity™ Takeda Cytomegalovirus (CMV) infection November 2021
difelikefalin Korsuva® Cara Therapeutics Chronic kidney disease-associated pruritis (CKD-aP) in hemodialysis patients August 2021
fexinidazole N/A Sanofi Trypanosoma brucei gambiense form of sleeping sickness July 2021
finerenone Kerendia® Bayer Chronic kidney disease (CKD) and type 2 diabetes July 2021
brincidofovir Tembexa® Chimerix Smallpox June 2021
ibrexafungerp Brexafemme® Scynexis Antifungal June 2021
olanzapine and samidorphan Lybalvi® Alkermes Schizophrenia or bipolar I disorder June 2021
estetrol and drospirenone (E4/DRSP) Nextstellis Mayne Pharma, Mithra Pharmaceuticals Pregnancy prevention April 2021
viloxazine hydrochloride Qelbree Supernus Pharmaceuticals ADHD April 2021

*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*
amlodipine oral solution Norliqva® CMP Pharma, Inc. Hypertension February 2022
baclofen Fleqsuvy® Azurity Pharmaceuticals Spasticity associated with multiple sclerosis February 2022
mometasone furoate and olopatadine hydrochloride Ryaltris nasal spray® Glenmark Pharmaceuticals Seasonal allergic rhinitis January 2022
glycopyrrolate orally disintegrating tablets Dartisla ODT™ Edenbridge Pharmaceuticals Peptic ulcer December 2021
tadalafil/finasteride Entadfi™ Veru Benign prostatic hyperplasia December 2021
baclofen oral granules Lyvispah® Saol Spasticity resulting from multiple sclerosis December 2021
clindamycin 2% hydrogel Xaciato® Daré Bioscience Bacterial vaginosis December 2021
topiramate oral solution,

25 mg/mL

Eprontia® Azurity Pharmaceuticals Seizures November 2021
pilocarpine HCL

ophthalmic solution

1.25%

Vuity® Allergan Presbyopia October 2021
tramadol 44mg and celecoxib 56mg tablet Seglentis® Esteve Pharmaceuticals and Kowa Pharmaceuticals America Pain October 2021
varenicline nasal spray Tyrvaya® Oyster Point Pharma Dry eye disease October 2021
naloxone pre-filled syringe Zimhi® Adamas Pharma Opioid overdose October 2021
atogepant Qulipta® AbbVie Preventive treatment of migraine September 2021
paliperidone palmitate extended-release injectable suspension Invega Hafyera® Janssen Pharmaceuticals, Inc. Schizophrenia September 2021
dihydroergotamine mesylate, DHE Trudhesa® Impel Neuropharma Migraine September 2021
benzoyl peroxide and tretinoin Twyneo® Sol-Gel Technologies Acne vulgaris July 2021
torsemide Soaanz® Sarfez Pharmaceuticals Edema caused by heart failure June 2021
cyclosporine ophthalmic emulsion Verkazia Santen Vernal keratoconjunctivitis June 2021
ephedrine injection Rezipres® Eton Pharmaceuticals Hypotension June 2021
semaglutide Wegovy Novo Nordisk Chronic weight management June 2021
relugolix, estradiol and norethindrone Myfembree Myovant (Sumitomo Dainippon) Heavy menstrual bleeding June 2021
bupivacaine and meloxicam extended-release solution Zynrelef Heron Therapeutics Postoperative pain May 2021
naloxone hydrochloride nasal spray Kloxxado Hikma Pharmaceuticals Emergency treatment of known or suspected opioid overdose April 2021

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

PIPELINE WATCH
Generic Name Brand Name Manufacturer Indication(s) Anticipated FDA Decision Date
benzoyl peroxide Epsolay Sol-Gel Technologies Rosacea Delayed
ET-104 (zonisamide oral suspension) N/A Azurity Pharmaceuticals Anticonvulsant Delayed
AXS-05 (dextromethorphan and bupropion) N/A Axsome Therapeutics Major depressive disorder Delayed
reltecimod N/A Atox Bio Necrotizing soft tissue infection Delayed
testosterone undecanoate Kyzatrex® Marius Pharmaceuticals Hypogonadism Delayed
dextroamphetamine transdermal system (ATS) N/A Noven Therapeutics ADHD Delayed
diazepam buccal film Libervant™ Aquestive Therapeutics Seizures Delayed
oteseconazole (VT-1161) N/A Mycovia Pharmaceuticals Vulvovaginal candidiasis Delayed
dihydroergotamine (DHE) autoinjector N/A Amneal Acute migraine Delayed
letibotulinumtoxinA N/A Hugel America Frown lines March 2022
udenafil N/A Mezzion Pharma Single ventricle heart disease (SVHD) who have undergone the Fontan operation March 2022
donepezil, transdermal Adlarity® Corium Alzheimer’s disease March 2022
meloxicam-rizatriptan MoSEIC™ Axsome Therapeutics Acute migraine April 2022
BXCL501 (dexmedetomidine orally dissolving film) N/A BioXcel Therapeutics Schizophrenia and bipolar disorders April 2022
cantharidin 0.7% topical solution Ycanth® Verrica Pharmaceuticals Molluscum contagiosum May 2022
tapinarof (DMVT-505) N/A Dermavant (Roivant) Plaque psoriasis May 2022
vonoprazan N/A Phathom Pharmaceuticals Triple therapy for Helicobacter pylori May 2022
vonoprazan N/A Phathom Pharmaceuticals Dual therapy for Helicobacter pylori May 2022
tirzepatide N/A Lilly Type 2 diabetes June 2022
tebipenem pivoxil hydrobromide N/A Spero Therapeutics Complicated urinary tract infections (cUTI), including pyelonephritis June 2022
paracetamol and ibuprofen solution for infusion Maxigesic® IV Hyloris Pharmaceuticals SA Postoperative pain September 2022
linzagolix N/A ObsEva Uterine fibroids September 2022
omecamtiv mecarbil N/A Cytokinetics Heart failure with reduced ejection fraction November 2022

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

FIRST GENERIC LAUNCHES OF TOP SELLING BRAND NAME DRUGS IN THE PAST TWELVE MONTHS
Generic Name Brand Name Brand Manufacturer Indication(s) Approval Date*
lenalidomide+ Revlimid® (5, 10, 15, 25mg) Celgene/ BMS Non-Hodgkin’s Lymphoma March 2022
cyclosporine ophthalmic emulsion,

0.05%

Restasis® Allergan Increase tear production due to ocular inflammation associated with keratoconjunctivitis sicca February 2022
vasopressin inj,

20 unit/mL

Vasostrict® Par Sterile Products Increase blood pressure January 2022
naloxone hydrochloride Narcan® (nasal spray) Adapt Pharma Opioid overdose December 2021
adapalene; benzoyl peroxide Epiduo Forte® Galderma Acne vulgaris December 2021
zolmitriptan nasal spray, 5mg/spray Zomig® nasal spray AstraZeneca Migraine headache November 2021
everolimus+ Afinitor® (10mg) Novartis Kidney cancer October 2021
everolimus+ Afinitor® Disperz Novartis Certain forms of cancer October 2021
difluprednate ophth emulsion, 0.05% Durezol® Novartis Endogenous Anterior Uveitis September 2021
nebivolol Bystolic® Allergan Hypertension September 2021
sunitinib malate+ Sutent® CPPI CV Cancer August 2021
ibuprofen/famotidine Duexis® Horizon Therapeutics USA Rheumatoid arthritis (RA), osteoarthritis (OA), ulcers August 2021
ferumoxytol Feraheme® AMAG Pharmaceuticals Anemia July 2021
formoterol fumarate Perforomist® Mylan COPD June 2021
arformoterol tartrate Brovana® Sunovion COPD June 2021
rufinamide Banzel® Eisai Seizures associated with Lennox-Gastaut Syndrome June 2021
isotretinoin Absorica® Ranbaxy Acne May 2021

*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.
+Specialty medication

OTHER FIRST GENERIC LAUNCHES IN THE PAST TWELVE MONTHS
Generic Name Brand Name Brand Manufacturer Indication(s) Approval Date*
apomorphine inj, +

30 mg/3 mL

Apokyn® Supernus Pharmaceuticals Parkinson’s disease March 2022
carbidopa/levodopa/

entacapone tabs,

12.5-50-200mg,

18.75-75-200mg,

25-100-200mg,

31.25-125-200mg,

37.5-150-200mg,

50-200-200mg

Stalevo® Almatica Parkinson’s disease March 2022
amphotericin b liposome IV for susp, 50mg Ambisome® Astellas Fungal infections February 2022
deferiprone tab,

1000mg

Ferriprox® Chiesi USA  Chronic iron overload February 2022
digoxin tab,

62.5mcg

Lanoxin® Concordia Pharmaceuticals Heart failure, atrial fibrillation February 2022
maraviroc tabs,

150mg, 300mg

Selzentry® Viiv Healthcare HIV February 2022
betaine powder for oral soln Cystadane® Recordati Rare Diseases Homocystinuria February 2022
romidepsin for inj, 10mg Istodax® B-M Squibb U.S. Certain forms of cutaneous T-cell lymphoma (CTCL) January 2022
glycopyrrolate oral soln,

1mg/5mL

Cuvposa® Merz Pharmaceuticals Severe drooling associated with neurologic conditions January 2022
clocortolone crm, 0.1% Cloderm® EPI Health Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses December 2021
nelarabine inj,

5mg/mL+

Arranon® Novartis Certain forms of T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma November 2021
everolimus tab,

1mg

Zortress® Novartis Prophylaxis of organ rejection in certain transplantations November 2021
enalapril oral soln, 1mg/mL Epaned® Azurity Pharmaceuticals Heart failure, hypertension August 2021
buprenorphine buccal film Belbuca® Biodelivery Sciences Pain management August 2021
atropine prefilled syringe inj, 0.25mg/5mL (0.05mg/mL) N/A Hospira Temporary blockade of severe or life-threatening muscarinic effects August 2021
argatroban Argatroban® Hikma Heparin-induced thrombocytopenia (HIT) July 2021
etravirine Intelence® Janssen HIV June 2021
lopinavir, ritonavir Kaletra® AbbVie HIV June 2021
bepotastine ophth soln, 1.5% Bepreve® Bausch Health Allergic conjunctivitis June 2021
tiopronin tab Thiola® Travere Therapeutics Prevention of cystine stone formation May 2021
pregabalin Lyrica CR® Pfizer Neurological pain April 2021

*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.
+Specialty medication

GENERICS OF TOP SELLING BRAND DRUGS POTENTIALLY AVAILABLE SOON
Generic Name Brand Name Brand Manufacturer Indication(s) To Market Date*
goserelin acetate+ Zoladex® AstraZeneca Prostate cancer 04/13/2022
dabigatran etexilate mesylate Pradaxa® (capsules) BI Atrial fibrillation 2Q 2022
oxycodone hydrochloride Oxaydo® Egalet Pain 1H 2022
ethinyl estradiol; levonorgestrel Balcoltra® Avion Pharmaceuticals Contraception 2022
formoterol fumarate; mometasone furoate Dulera® Merck Asthma 2022
enalapril maleate Epaned® KIT Silvergate Heart failure 2022
fluticasone propionate Flovent® HFA GSK Asthma 2022
cabazitaxel+ Jevtana® Kit Sanofi Prostate cancer 2022
rotigotine Neupro® UCB Parkinson’s disease 2022
ritonavir Norvir® (capsules) AbbVie HIV 2022
benzoyl peroxide; clindamycin phosphate Onexton® Dow Pharmaceutical Acne vulgaris 2022
lenalidomide+ Revlimid® (2.5, 20mg) Celgene/ BMS Non-Hodgkin’s lymphoma 2022
octreotide acetate+ Sandostatin® LAR Novartis Endocrine gland disease 2022
thalidomide+ Thalomid® Celgene/ BMS Leprosy 2022
fesoterodine fumarate Toviaz® Pfizer Overactive bladder 2022
tafluprost Zioptan® Akorn Glaucoma 2022

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

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