Traditional Drug Pipeline Quarterly Update: September 2022

Critical updates in an ever changing environment

September 30, 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

  • Daxxify® (daxibotulinumtoxinA-lanm): The U.S. Food and Drug Administration (FDA) has approved Revance’s Daxxify for injection for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults. Approval of Daxxify was based on the Phase 3 clinical trial, SAKURA, which demonstrated 74% of subjects achieved a > two-grade improvement in glabellar lines at week four per both investigator and patient assessment, and 88% achieved > two-grade improvement at week four per investigator assessment.1 Daxxify had a median duration of six months. Launch and pricing of Daxxify are pending.
  • Aponvie® (aprepitant): The FDA has approved Heron Therapeutics’ Aponvie injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults. Aponvie is a neurokinin-1 (NK1) receptor antagonist that was approved via the 505(b)2 pathway using Merck Sharp & Dohme Corp’s Emend®as its reference drug. Delivered via a single 30-second IV injection, Aponvie has demonstrated rapid achievement of therapeutic drug levels ideally suited for the surgical setting.2 Aponvie launch and price are pending.

Generic Drug Information

  • Vascepa® 0.5gm (icosapent ethyl): Teva launched their generic version of Amarin’s Vascepa® 0.5gm (icosapent ethyl), as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia or as an adjunctive therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 mg/dL or higher. In 2020, multiple manufactures launched their generic version of Vascepa 1gm. Both strengths of Vascepa combined generated $1331 million in U.S. annual sales in 2021.
  • Revlimid® 2.5, 20mg capsules (lenalidomide cap, 2.5mg, 20mg) : Dr. Reddy’s has launched their generic version of Bristol-Myers Squibb’s Revlimid 2.5, 20mg. 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 and mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Dr. Reddy’s is eligible for 180-day exclusivity for these strengths. Multiple manufacturers are scheduled to launch in 2023. Revlimid 2.5mg and 20mg capsules generated $815 million in U.S. annual sales in 2021.
  • Suprep® (sodium sulfate/potassium sulfate/magnesium sulfate oral soln, 17.5-3.13-1.6 gm/177 mL): Lupin Pharmaceuticals launched their generic version of Braintree Lab’s Suprep, an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. Suprep generated $292 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*

 

roflumilast cream Zoryve™ Arcutis Biotherapeutics, Inc. Plaque psoriasis July 2022  
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  

* 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*
aprepitant Aponvie™ Heron Therapeutics Prevention of postoperative nausea and vomiting September 2022  
daxibotulinumtoxinA-lanm Daxxify™ Revance Therapeutics Glabellar (frown) lines September 2022  
omeprazole and sodium bicarbonate Konvomep™ Azurity Pharmaceuticals Gastric ulcers August 2022  
diazepam buccal film Libervant™

Tentative approval

Aquestive Therapeutics Seizures August 2022  
dextromethorphan and bupropion Auvelity® Axsome Therapeutics Major depressive disorder August 2022  
testosterone undecanoate Kyzatrex® Marius Pharmaceuticals Hypogonadism August 2022  
zonisamide oral suspension Zonisade® Azurity Pharmaceuticals Anticonvulsant July 2022  
venlafaxine besylate Venbysi® XR Almatica Pharma Depression, anxiety June 2022  
drospirenone Drospirenone® chewable tablets Exeltis Pregnancy prevention June 2022  
methylphenidate hydrochloride Relexxii® Osmotica Pharmaceuticals Attention deficit hyperactivity disorder (ADHD) June 2022  
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,

25 mg/mL

Eprontia® Azurity Pharmaceuticals Seizures November 2021  
pilocarpine HCL

ophthalmic solution

1.25%

Vuity® Allergan Presbyopia October 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
reltecimod N/A Atox Bio Necrotizing soft tissue infection 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  
linzagolix N/A ObsEva Uterine fibroids September 2022  
lenacapavir N/A Gilead Sciences HIV December 2022  
PT027 (albuterol and budesonide) N/A Avillion and AstraZeneca Asthma January 2023  
fezolinetant N/A Astellas Vasomotor symptoms (VMS) associated with menopause February 2023  
omecamtiv mecarbil N/A Cytokinetics Heart failure with reduced ejection fraction February 2023  
ABBV-951 (foscarbidopa and foslevodopa) N/A AbbVie Parkinson’s disease March 2023  
rezafungin N/A Cidara and Melinta Antifungal March 2023  
zavegepant N/A Biohaven (Pfizer to acquire) Migraine March 2023  
sotagliflozin Zynquista® Lexicon Pharmaceuticals Heart failure May 2023  
aripiprazole 2-month, ready-to-use injectable N/A Otsuka and Lundbeck Bipolar May 2023  
NOV03 (perfluorohexyloctane) N/A Bausch + Lomb Corporation Dry eye disease June 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*
icosapent ethyl cap, 0.5 gm Vascepa cap® Amarin Pharma Hypertriglyceridemia September 2022  
sodium sulfate/potassium sulfate/magnesium sulfate oral soln, 17.5-3.13-1.6 gm/177 mL Suprep® Braintree Lab Bowel cleansing September 2022  
lenalidomide+ Revlimid® (2.5, 20mg) Celgene Myelodysplastic syndromes September 2022  
dabigatran cap,

75 mg, 150 mg

Pradaxa® Boehringer Ingelheim Reduce the risk of stroke and systemic embolism, deep venous thrombosis and pulmonary embolism July 2022  
fesoterodine tab,

4 mg, 8 mg

Toviaz® Pfizer U.S. Overactive bladder July 2022  
vilazodone tab,

10 mg, 20 mg, 40 mg

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

100 mg, 500 mg

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,

267 mg, 801 mg

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

3.5 mg+

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

50 mg, 100 mg,

150 mg, 200 mg

Vimpat® tab,

50 mg, 100 mg, 150 mg, 200 mg

UCB Pharma Partial-onset seizures; primary generalized tonic-clonic seizures March 2022  
lenalidomide+ Revlimid® (5, 10, 15, 25 mg) 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, 5 mg/spray Zomig® nasal spray AstraZeneca Migraine headache November 2021  
everolimus+ Afinitor® (10 mg) Novartis Kidney cancer October 2021  
everolimus+ Afinitor® Disperz Novartis Certain forms of cancer October 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*
timolol (pf) ophth soln, 0.25% Timoptic® Ocudose, 0.25% Bausch Health Glaucoma/ocular hypertension September 2022
atropine sulfate IV soln,

0.4 mg/mL, 1 mg/mL

Atropine Sulfate® Accord Healthcare Temporary blockade of severe or life threatening muscarinic effects August 2022
iodixanol inj,

270 mg/mL

Visipaque® GE Healthcare Intra-arterial procedures, Intravenous procedures July 2022
methylphenidate TD patch, 10mg/9 hour, 15mg/9 hour, 20mg/9 hour, 30mg/9 hour Daytrana® Noven Therapeutics ADHD July 2022
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® 500 mg Shire Ulcerative colitis/

Crohn’s Disease

May 2022
lacosamide oral soln,

10mg/mL

Vimpat® oral soln, 10 mg/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,

4 mg/mL

Prexxartan® (discontinued) Medicure Hypertension April 2022
isosorbide dinitrate-hydralazine tab, 20-37.5 mg 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®,

25 mg

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

*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*
rufinamide Banzel® (100mg tablets) Eisai Epilepsy 2H2022  
sodium oxybate+ Xyrem® Jazz Pharmaceuticals Sleep 2H 2022  
gefitinib+ Iressa AstraZeneca Lung cancer 3Q2022  
oxycodone hydrochloride Oxaydo® Egalet Pain 2022  
enalapril maleate Epaned KIT® Silvergate Hypertension 2022  
fluticasone propionate Flovent HFA® GSK Asthma 2022  
rotigotine Neupro® UCB Parkinson’s disease 2022  
ritonavir Norvir® (capsules) AbbVie HIV 2022  
benzoyl peroxide; clindamycin phosphate Onexton® Dow Pharmaceutical Sciences Acne 2022  
octreotide acetate+ Sandostatin® LAR Novartis Endocrine gland diseases 2022  
thalidomide Thalomid® Celgene Leprosy 2022  
tafluprost Zioptan® Akorn Glaucoma or ocular hypertension 2022  
ethinyl estradiol; levonorgestrel Balcoltra® Avion Pharmaceuticals Pregnancy prevention 2022-2024  

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

+Specialty medication

Related news

Perspectives

November 28, 2022

Specialty Pipeline Quarterly Update: November 2022

This quarterly pipeline wrap-up provides a review of newly approved specialty drugs, recent…

Perspectives

November 18, 2022

Traditional Drug Pipeline Quarterly Update: November 2022

This quarterly pipeline wrap-up provides a review of newly approved traditional drugs, recent…

Perspectives

November 15, 2022

Three Minutes with Mitchell Scott

Mitchell Scott is Senior Director of Prime’s Special Investigations Unit (SIU) and Pharmacy…