Traditional Drug Pipeline Quarterly Update: June 2022

Critical updates in an ever changing environment

July 12, 2022

This quarterly 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 articles for pipeline information on specialty drugs, cell/gene therapies and biosimilars.

 New Drug Information

  • Vtama® (tapinarof cream, 1%): The U.S. Food and Drug Administration (FDA) has approved Dermavant Sciences’ Vtama (tapinarof) cream, 1%, indicated for the topical treatment of plaque psoriasis in adults. Vtama cream is the first in a new class, aryl hydrocarbon receptor (AhR) agonists. Vtama’s approval was based on two Phase 3 studies, PSOARING1 and PSOARING2 which found 36% and 40% of patients treated with tapinarof cream met the primary endpoint of clear or almost clear based on the Physician Global Assessment (PGA) score compared to 6% and 6% for treatment with vehicle.1 Vtama has launched with a wholesale acquisition cost (WAC) of $1,325 per 60 gram tube.

Generic Drug Information

  • Alimta®+ (pemetrexed injection 100mg, 500mg): Multiple manufacturers have launched their generic version of Eli Lilly’s Alimta® (premetrexed disodium), a folate analog metabolic inhibitor indicated for:
    1. Locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC)
      1. Initial treatment in combination with pembrolizumab and platinum chemotherapy
      2. Initial treatment in combination with cisplatin
      3. Maintenance treatment of patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
      4. After prior chemotherapy as a single agent
    2. Mesothelioma: in combination with cisplatin

There are no remaining legal or regulatory barriers and multiple manufactures are planning to launch their generic versions this year. Alimta generated $1.641 billion in U.S. annual sales in 2021.

  • Targretin®+ (bexarotene gel 1%): Multiple manufacturers have launched their generic version of Bausch Health’s Targretin for skin problems arising from a disease called cutaneous T-cell lymphoma, or CTCL, in patients who have not responded well to other treatments. Targretin gel generated $26 million in U.S. annual sales in 2021.
  • Nexavar®+ (sorafenib tab, 200mg): Dr. Reddy’s and Mylan have launched their generic version of Bayer Healthcare Pharma’s Nexavar indicated for hepatocellular carcinoma, renal cell carcinoma, differentiated thyroid carcinoma. Naxavar generated $170 million in U.S. annual sales in 2021.
  • Viibryd®+ (vilazodone): Multiple manufacturers have launched their generic version of Allergan’s Viibryd for major depressive disorder. Viibryd generated $603 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*
tapinarof cream, 1% Vtama™ Dermavant (Roivant) Plaque psoriasis May 2022  
amoxicillin/clarithromycin/vonoprazan Voquezna Triple Pak™ Phathom Pharmaceuticals Triple therapy for Helicobacter pylori May 2022  
amoxicillin/vonoprazan Voquezna Dual Pak™ Phathom Pharmaceuticals Dual therapy for

Helicobacter pylori

May 2022  
tirzepatide Mounjaro™ Lilly Type 2 diabetes May 2022  
oteseconazole Vivjoa™ Mycovia Pharmaceuticals Vulvovaginal candidiasis April 2022  
dexmedetomidine orally dissolving film Igalmi™ BioXcel Therapeutics Schizophrenia and bipolar disorders April 2022  
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  

* 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*
acetaminophen Acetaminophen® InnoPharma Pain June 2022  
testosterone cypionate Testosterone Cypionate® Slayback Hypogonadism June 2022  
tecovirimat Tpoxx® IV SIGA Technologies Smallpox May 2022  
levothyroxine sodium Ermeza Mylan/Viatris Hypothyroidism April 2022  
glycopyrrolate Glycopyrrolate® Fresenius Reduction of secretions in anesthesia and for peptic ulcer April 2022  
benzoyl peroxide Epsolay Sol-Gel Technologies Rosacea April 2022  
dextroamphetamine transdermal system (ATS) Xelstrym® Noven Therapeutics ADHD March 2022  
donepezil, transdermal Adlarity® Corium Alzheimer’s disease March 2022  
levothyroxine sodium Ermeza™ Mylan/Viatris Hypothyroidism May 2022  
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,

25mg/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  

* 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*
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  
diazepam buccal film Libervant™ Aquestive Therapeutics Seizures Delayed  
dihydroergotamine (DHE) autoinjector N/A Amneal Acute migraine Delayed  
letibotulinumtoxinA N/A Hugel America Frown lines Delayed  
udenafil N/A Mezzion Pharma Single ventricle heart disease (SVHD) who have undergone the Fontan operation Delayed  
tebipenem pivoxil hydrobromide N/A Spero Therapeutics Complicated urinary tract infections (cUTI), including pyelonephritis June 2022  
roflumilast cream (ARQ-151) N/A Arcutis Biotherapeutics, Inc. Plaque psoriasis July 2022  
taurolidine, heparin and citrate

 

Defencath®

 

Cormedix Inc Prevention of certain catheter-related bloodstream infection August 2022  
paracetamol and ibuprofen solution for infusion Maxigesic® IV Hyloris Pharmaceuticals SA Postoperative pain September 2022  
linzagolix N/A ObsEva Uterine fibroids September 2022  
HTX-019 (aprepitant) N/A Heron Therapeutics Prevention of postoperative nausea and vomiting September 2022  
omecamtiv mecarbil N/A Cytokinetics Heart failure with reduced ejection fraction November 2022  
PT027 (albuterol and budesonide) N/A Avillion and AstraZeneca Asthma January 2023  
FIRST GENERIC LAUNCHES OF TOP SELLING BRAND NAME DRUGS IN THE PAST TWELVE MONTHS
Generic name Brand name BRAND Manufacturer Indication(s) approval date*
vilazodone tab,

10mg, 20mg, 40mg

Viibryd® Allergan Major depressive disorder June 2022  
pemetrexed inj,+

100mg, 500mg

Alimta® Lilly Non-squamous non-small cell lung cancer (NSCLC), mesothelioma May 2022  
diclofenac soln, 2% Pennsaid® Horizon Therapeutics USA Pain of osteoarthritis of the knee(s) May 2022  
pirfenidone tab,

267mg, 801mg

Esbriet® Genentech Idiopathic pulmonary fibrosis (IPF) May 2022  
bortezomib inj,

3.5mg+

Velcade® Takeda Pharmaceuticals Multiple myeloma, mantle cell lymphoma May 2022  
lacosamide tab,

50mg, 100mg,

150mg, 200mg

Vimpat® tab,

50mg, 100mg, 150mg, 200mg

UCB Pharma Partial-onset seizures; primary generalized tonic-clonic seizures March 2022  
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  

*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*
sorafenib tab,

200mg

Nexavar® Bayer Healthcare Pharma Hepatocellular carcinoma, renal cell carcinoma, differentiated thyroid carcinoma June 2022
bexarotene gel, +  1% Targretin® Bausch Health Cutaneous lymphoma May 2022
mesalamine ER cap, 500mg Pentasa®

500mg

Shire Ulcerative colitis/

Crohn’s Disease

May 2022
lacosamide oral soln,

10mg/mL

Vimpat® oral soln, 10mg/mL UCB Pharma Partial-onset seizures in patients with epilepsy May 2022
varenicline tab,

0.5mg X 11 & 1mg X 42

Chantix® Starting Month Pak Pfizer U.S. An aid to smoking cessation treatment April 2022
valsartan oral soln,

4mg/mL

Prexxartan® (discontinued) Medicure Hypertension April 2022
isosorbide dinitrate-hydralazine tab, 20-37.5mg Bidil® Arbor Pharmaceuticals Heart failure April 2022
lacosamide iv inj,

200mg/20 mL

Vimpat® UCB Pharma Partial-onset seizures, primary generalized tonic-clonic seizures April 2022
diclofenac cap, 25mg Zipsor cap®,

25mg

Assertio Therapeutics Relief of mild to moderate acute pain March 2022
tolvaptan tab, 15mg Samsca tab®         (15mg) Otsuka America Hypervolemic and

euvolemic hyponatremia

March 2022
apomorphine inj, + 30mg/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, 62.5 mcg 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/5 mL

Cuvposa® Merz Pharmaceuticals Severe drooling associated with neurologic conditions January 2022
clocortolone cream, 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/5 mL (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

*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.

GENERICS OF TOP SELLING BRAND DRUGS POTENTIALLY AVAILABLE SOON
Generic name Brand name brand Manufacturer Indication(s) To market date*
rufinamide Banzel® (100mg tablets) Eisai Epilepsy June 2022  
vandetanib+ Caprelsa® AstraZeneca Thyroid cancer June 2022  
methylphenidate Daytrana® Noven Pharmaceuticals ADHD 2Q 2022  
dabigatran etexilate mesylate Pradaxa® (capsules) Boehringer Ingelheim Atrial fibrillation 2Q 2022  
lacosamide Vimpat® (oral solution) UCB Epilepsy 2Q 2022  
oxycodone hydrochloride Oxaydo® Egalet Pain 1H 2022  
sodium oxybate+ Xyrem® Jazz Pharmaceuticals Sleep 2H 2022  
ethinyl estradiol; levonorgestrel Balcoltra® Avion Pharmaceuticals Pregnancy prevention 2022  
enalapril maleate Epaned KIT® Silvergate Hypertension 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 Sciences Acne 2022  
lenalidomide+ Revlimid® (2.5, 20mg) Celgene Myelodysplastic syndromes 2022  
octreotide acetate+ Sandostatin® LAR Novartis Endocrine gland diseases 2022  
bexarotene+ Targretin® (gel) Valeant Non-Hodgkin’s Lymphoma 2022  
thalidomide Thalomid® Celgene Leprosy 2022  
fesoterodine fumarate Toviaz® Pfizer Overactive bladder 2022  
tafluprost Zioptan® Akorn Glaucoma or ocular hypertension 2022  

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

+Specialty medication

REFERENCES
  1. https://www.globenewswire.com/news-release/2022/05/24/2449068/34323/en/FDA-Approves-Dermavant-s-VTAMA-tapinarof-cream-1-for-the-Treatment-of-Plaque-Psoriasis-in-Adults-First-Topical-Novel-Chemical-Entity-Launched-for-Psoriasis-in-the-U-S-in-25-Years.html

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