Traditional Drug Pipeline Quarterly Update: March 2023

Critical updates in an ever changing environment

March 27, 2023

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 articles for pipeline information on specialty drugs, biosimilars and  gene/cell therapy. 

New Drug Information

  • Zavzpret® (zavegepant): The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Zavzpret for the acute treatment of migrainewith or without aura in adults. Zavzpret is the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray. Zavzpret was approved based on the Phase 3 study that demonstrated Zavzpret was statistically superior to placebo on the two co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) at two hours post-dose. Twenty-two percent of patients treated with Zavzpret 10mg and 23% of patients treated with Zavzpret 20mg were pain free after dosing compared to 15.5% of patients treated with placebo. Almost half of patients (10mg: 41.9%, 20mg: 42.5%) treated with Zavzpret were free from MBS at two hours after receiving treatment compared to 22.7% of patients treated with placebo.1 Zavzpret will be available July 2023 with pricing to follow.

Generic Drug Information

  • Zonalon® (doxepin hcl cream 5%): Teva launched their generic version of Mylan’s Zonalon for the short-term (up to eight days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. Zonalon cream generated less than $10 million in U.S. annual sales in 2022.
  • Aubagio® (teriflunomide 7mg, 14mg)+: Multiple manufacturers have launched their generic versions of Sanofi/Genzyme’s Aubagio indicated for the treatment of patients with relapsing forms of multiple sclerosis. Additional manufacturers are scheduled to launch their versions this year. Aubagio generated $2,009 million in U.S. annual sales in 2022.
  • Pylera® (bismuth subcit-metronidazole-tetracycline cap140-125-125 mg): Par Pharmaceuticals launched their generic version of Allergan’s Pylera indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past five years) to eradicate H. pylori. Also indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of Pylera and other antibacterial drugs, Pylera should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Pylera generated $42 million in U.S. annual sales in 2022.

+Specialty medication

References

  1. https://www.neurologylive.com/view/zavegepant-becomes-first-fda-approved-nasal-spray-acute-migraine
New Molecular Entity Approvals in the Past Twelve Months
Generic Name Brand Name Manufacturer Indication(s) Date Approved*

 

zavegepant Zavzpret® Pfizer Migraine March 2023
bexagliflozin Brenzavvy™ TheracosBio Type 2 diabetes January 2023
lenacapavir Sunlenca™ Gilead Sciences HIV-1 December 2022
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

*          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*
naloxone Naloxone® Hydrochloride Nasal Spray Amphastar Opioid overdose March 2023
paracetamol 325 mg/ ibuprofen 97.5 mg Maxigesic® Rapid Tablet AFT Pharmaceuticals/ Hikma/Hyloris Pain March 2023
risperidone for extended-release injectable suspension Rykindo® Luye Pharma Group Schizophrenia and bipolar January 2023
albuterol and budesonide Airsupra® Avillion/ AstraZeneca Asthma January 2023
latanoprost ophthalmic solution 0.005% Iyuzeh® Thea Pharma Reduction of elevated intraocular pressure December 2022
methotrexate oral solution Jylamvo® Therakind Certain forms of autoimmune conditions November 2022
phenobarbital sodium Sezaby™ Sun Pharma Neonatal seizures in term and preterm infants November 2022
omidenepag isopropyl ophthalmic solution, eye drops,

0.002%

Omlonti™ Santen Pharmaceutical Reduction of elevated intraocular pressure (IOP) September 2022
chloroprocaine hydrochloride ophthalmic, gel, 3% Iheezo™ Harrow Ocular surface anesthesia September 2022
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

* 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
tenapanor Xphozah® Ardelyx For control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. 2023
rezafungin N/A Cidara/ Melinta Antifungal March 2023
rizatriptan, oral film Rizafilm® IntelGenx/ Gensco Migraine April 2023
letibotulinumtoxinA N/A Hugel America Frown lines April 2023
aripiprazole two-month, ready-to-use injectable N/A Otsuka/ Lundbeck Bipolar April 2023
naloxone 3mg nasal spray RiVive® Harm Reduction Therapeutics Opioid overdose April 2023
sotagliflozin Zynquista® Lexicon Pharmaceuticals Heart failure May 2023
fezolinetant N/A Astellas Vasomotor symptoms (VMS) associated with menopause May 2023
buprenorphine depot Brixadi® Braeburn Pharmaceutical Opioid overdose May 2023
sulbactam/ durlobactam N/A Innoviva (Entasis) Infection May 2023
phenylephrine/ tropicamide MydCombi® Eyenovia Mydriasis May 2023
clotrimazole, otic N/A Salvat Laboratories Otomycosis June 2023
olorofim N/A F2G Antifungal June 2023
gepirone extended release Exxua Fabre-Kramer Major depressive disorder June 2023
NOV03 (perfluorohexyloctane) N/A Bausch + Lomb Corporation Dry eye disease June 2023
IPX203 (carbidopa/ levodopa) N/A Amneal Pharmaceuticals Parkinson’s disease June 2023
cyclosporine ophthalmic solution CyclASol® Novaliq Dry eye disease June 2023
cantharidin 0.7% topical solution Ycanth® Verrica Pharmaceuticals Molluscum contagiosum July 2023
brimonidine tartrate 0.35% N/A Visiox/ Sun Pharma Advanced Research Company Glaucoma August 2023
zuranolone N/A Sage Therapeutics/ Biogen Major depressive disorder and postpartum depression August 2023
metronidazole oral suspension N/A Saptalis Pharmaceuticals/ Appili Infection September 2023
sofpironium bromide N/A Botanix Pharmaceuticals/ Brickell Biotech Primary axillary hyperhidrosis September 2023
phentolamine ophthalmic solution 0.75% Nyxol® Ocuphire/ Viatris (FamyGen) Mydriasis September 2023
CSF1 (low dose pilocarpine hydrochloride 0.4%) N/A Orasis Pharmaceuticals Improve near vision for people with presbyopia October 2023
reproxalap N/A Aldeyra Therapeutics Dry eye disease November 2023
OX124 (naloxone, nasal) N/A Orexo Opioid overdose December 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*
teriflunomide tab,

7mg, 14mg+

Aubagio® Genzyme Multiple sclerosis (MS) March 2023
lurasidone tablet,

20mg, 40mg, 60mg, 80mg, 120mg

Latuda® Sunovion Pharmaceuticals Schizophrenia February 2023
pirfenidone+ Esbriet® (capsule) InterMune/ Genentech Respiratory system diseases January 2023
topiramate cap er 24HR, 25mg, 50mg, 100mg Trokendi XR® Supernus Pharmaceuticals Seizures January 2023
dexlansoprazole cap delayed release,

60mg

Dexilant® Takeda Pharmaceuticals Erosive esophagitis (EE), heartburn, symptomatic non-erosive gastroesophageal reflux disease (GERD) December 2022
fingolimod cap,

0.5mg

Gilenya® cap Novartis Multiple sclerosis September 2022
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,

4mg, 8mg

Toviaz® Pfizer U.S. Overactive bladder July 2022
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

*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*
bismuth subcit-metronidazole-tetracycline cap,

140-125-125mg

Pylera® Allergan Helicobacter pylori infection and duodenal ulcer disease March 2023
doxepin hcl cream,

5%

Zonalon® Mylan Dermatitis or eczema February 2023
epinephrine inj,

1mg/mL

Adrenalin® inj, 1mg/mL Par Sterile Products Allergic reactions February 2023
bendamustine IV soln, 25mg, 100mg Treanda® Cephalon/Teva Certain forms of leukemia January 2023
brimonidine tartrate gel

0.33%

Mirvaso® gel 0.33% Galderma Rosacea January 2023
lubiprostone cap,

8mcg, 24mcg

Amitiza® Takeda Constipation January 2023
tasimelteon capsule,

20mg

Hetlioz® Vanda Pharmaceuticals Sleep disorders January 2023
diclofenac packet,

50mg

Cambia® Assertion Therapeutics Migraine January 2023
tafluprost preservative free (pf) ophth soln, 0.0015% Zioptan® Thea Pharma Reducing elevated intraocular pressure November 2022
penciclovir cream,

1%

Denavir® cream Mylan Herpes November 2022
roflumilast tab,

250 mcg, 500 mcg

Daliresp® tablet AstraZeneca Chronic obstructive pulmonary disease (COPD) October 2022
estradiol td gel,

0.25mg/0.25 gm (0.1%),

0.5mg/0.5 gm (0.1%),

0.75mg/0.75 gm (0.1%),

1mg/gm (0.1%),

1.25 mg/1.25 gm (0.1%)

Divigel® Vertical Pharmaceutical Menopause October 2022
tazarotene gel,

0.05%, 0.1%

Tazorac gel® Almirall Acne September 2022
timolol (pf) ophth soln, 0.25% Timoptic® Ocudose, 0.25% Bausch Health Glaucoma/ocular hypertension September 2022
atropine sulfate IV soln,

0.4mg/mL, 1mg/mL

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

270mg/mL

Visipaque® GE Healthcare Intra-arterial procedures, Intravenous procedures July 2022
methylphenidate TD patch, 10mg/9 hr, 15mg/9 hr, 20mg/9 hr, 30mg/9 hr 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, 500 mg Pentasa®

500 mg

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

*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*
teduglutide recombinant+ Gattex® NPS Pharma Short bowel syndrome March 2023
tirofiban hydrochloride Aggrastat® Medicure Ischemic Heart Diseases  March 2023
posaconazole Noxafil® (injection) Merck &Co Fungal infection 1Q 2023
prednisone Rayos® Horizon Pharma Steroid 1Q 2023
bendamustine hydrochloride+ Treanda® (solution) Cephalon Leukemia 1Q 2023
gefitinib+ Iressa® AstraZeneca Lung cancer 1H 2023
brimonidine tartrate Alphagan P® (0.1%) Allergan Glaucoma/ocular hypertension 2023
rufinamide Banzel® (100mg tablets) Eisai Epilepsy 2023
formoterol fumarate; mometasone furoate Dulera® Merck &Co Asthma 2023
diclofenac sodium Dyloject® Hospira Pain 2023
metformin hydrochloride; saxagliptin hydrochloride Kombiglyze® XR BMS Diabetes 2023
cyanocobalamin Nascobal® (spray) Par Anemia 2023
rotigotine Neupro® UCB Parkinson’s disease 2023
saxagliptin hydrochloride Onglyza® BMS Diabetes 2023
darunavir ethanolate Prezista® (300 mg tablets) Janssen HIV 2023

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

+Specialty medication

 

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