Traditional Drug Pipeline Quarterly Update: June 2023

Critical updates in an ever-changing environment

June 22, 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 specialtydrugs, biosimilars and  gene/cell therapy.

New Drug Information

  • Inpefa® (sotagliflozin): The U.S. Food and Drug Administration (FDA) has approved Lexicon Pharmaceuticals’ Inpefa, a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
    • heart failure or
    • type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

The once-daily tablet is the first SGLT1/SGLT2 inhibitor to reach the market. Inpefa’s approval was based on the placebo-controlled Phase 3 cardiovascular outcomes studies, SOLOIST-WHF, in patients with heart failure or at risk of it. Results from SOLOIST-WHF demonstrated that Inpefa significantly reduced risk of hospitalizations for heart failure, urgent visits for heart failure and cardiovascular death by 33% compared with placebo in patients who had been recently hospitalized for worsening heart failure.1 Lexicon expects Inpefa to become available by the end of June and will be priced “comparable to existing heart failure medications,” according to the manufacturer.

  • Vevye® (cyclosporine ophthalmic solution) 1%: The FDA approved Novaliq’s Vevye, formerly known as CyclASol, as a water-free ophthalmic solution formulation of the calcineurin inhibitor immunosuppressant for anti-inflammatory treatment of signs and symptoms of dry eye disease (DED). Vevye was approved via the 505(b)(2) pathway using Allergan’s Restasis® (cyclosporine ophthalmic emulsion 0.05%) as its reference product.2 Vevye launch and price are pending.
  • Lodoco® (colchicine): The FDA has approved Agepha Pharma USA’s Lodoco as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. Lodoco was approved based on the clinical stufy LoDoCo2 which met its primary endpoint of demonstrating a composite of cardiovascular (CV) death, spontaneous MI, ischemic stroke, or ischemia-driven coronary revascularization. After a median follow-up of 28.6 months, results showed that treatment with colchicine 0.5mg once daily reduced the risk of the primary composite endpoint by 31% compared with placebo.3 Lodoco will be available for prescription in the second half of 2023 with pricing to follow.

Generic Drug Information

  • Prezista® (darunavir tablet 600mg, 800mg): Lupin launched their version of Janssen’s Prezista for the treatment of HIV-1 infection in adult patients. Prezista is also indicated for the treatment of HIV-1 infection in pediatric patients 3 years of age and older. Prezista 600mg, 800mg generated $279 million in U.S. annual sales in 2022.
  • Noxafil® (posaconazole IV soln 300mg/16.7ml (18 mg/ml)): Par/Endo Pharmaceuticals has launched their generic version of Merck’s Noxafil for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. Noxafil injection generated $34 million in U.S. annual sales in 2022.

New Indications

  • Linzess® (linaclotide): The FDA approved an expanded indication for AbbVie’s Linzess (linaclotide) to include treatment of children and adolescents 6 to 17 years of age with functional constipation (FC).

References

  1. https://www.empr.com/home/news/fda-approves-inpefa-for-the-treatment-of-heart-failure/
  2. https://www.novaliq.com/press-releases/2023/06/08/novaliq-announces-fda-approval-of-vevye-cyclosporine-ophthalmic-solution-0-1-for-the-treatment-of-the-signs-and-symptoms-of-dry-eye-disease/
  3. https://www.empr.com/home/news/lodoco-approved-to-reduce-risk-of-cardiac-events-in-patients-with-cardiovascular-disease/
New Molecular Entity Approvals in the Past Twelve Months
Generic Name Brand Name Manufacturer Indication(s) Date Approved*

 

nirmatrelvir and ritonavir tablets co-packaged Paxlovid® Pfizer COVID-19 May 2023
sotagliflozin Inpefa® Lexicon Pharmaceuticals Heart failure May 2023
sulbactam/durlobactam Xacduro® Innoviva (Entasis) Infection May 2023
perfluorohexyloctane Miebo® Bausch + Lomb Corporation Dry eye disease May 2023
fezolinetant Veozah® Astellas Vasomotor symptoms (VMS) associated with menopause May 2023
rezafungin Rezzayo® Cidara and Melinta Candidemia and invasive candidiasis March 2023
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

*  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*
colchicine Lodoco® AGEPHA Pharma USA Reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease June 2023
cyclosporine ophthalmic solution Vevye® Novaliq Dry eye disease May 2023
lacosamide Motpoly XR® Aucta Pharmaceuticals Partial-onset seizures May 2023
nalmefene hydrochloride Opvee® Opiant Pharmaceuticals Treatment of known or suspected opioid overdose May 2023
buprenorphine depot Brixadi® Braeburn Pharmaceutical Opioid overdose May 2023
tropicamide and phenylephrine hydrochloride ophthalmic spray

1%/2.5%

MydCombi® Eyenovia Mydriasis May 2023
risperidone extended-release injectable suspension Uzedy® Teva Pharmaceuticals & MedinCell Schizophrenia April 2023
aripiprazole 2-month, ready-to-use injectable Abilify Asimtufii® Otsuka & Lundbeck Schizophrenia, bipolar disorder April 2023
rizatriptan, oral film Rizafilm® IntelGenx/ Gensco Migraine April 2023
naloxone, nasal spray

4mg

Narcan® Emergent BioSolutions Over the counter (OTC) switch for emergency treatment of known or suspected opioid overdose March 2023
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

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

New Indications for Approved Traditional Medications
Generic Name Brand Name Brand Manufacturer Indication Approval Date*
letermovir Prevymis® (injection) Merck & Co Prevention of cytomegalovirus diseases June 2023
linaclotide Linzess® Allergan/Ironwood Children 8-17 years of age with functional constipation June 2023
brexpiprazole Rexulti® H. Lundbeck A/S/ Otsuka Dementia-related agitation May 2023
dapagliflozin propanediol Farxiga® AstraZeneca Certain forms of heart failure May 2023
atogepant Qulipta® Allergan/ AbbVie Certain forms of migraines April 2023
naloxone hydrochloride Narcan® (nasal spray) Adapt Pharma/ Emergent BioSolutions/ Opiant Opioid overdose March 2023

 

Pipeline Watch
Generic Name Brand Name Manufacturer Indication(s) Anticipated FDA Decision Date
DS-100 (dehydrated alcohol injection) N/A Eton Pharmaceuticals Methanol poisoning June 2023
gepirone extended release Exxua™ Fabre-Kramer Major depressive disorder June 2023
IPX203 (carbidopa/ levodopa) N/A Amneal Pharmaceuticals Parkinson’s 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
tenapanor Xphozah® Ardelyx For control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. October 2023
CSF1 (low dose pilocarpine hydrochloride 0.4%) N/A Orasis Pharmaceuticals Improve near vision for people with presbyopia October 2023
paracetamol and ibuprofen Maxigesic® IV Hyloris Pharmaceuticals SA Post-operative pain October 2023
clotrimazole, otic N/A Salvat Laboratories Otomycosis 4Q2023
reproxalap N/A Aldeyra Therapeutics Dry eye disease November 2023
roflumilast foam N/A Arcutis biotherapeutics Seborrheic dermatitis December 2023
STS101 (dihydroergotamine nasal powder) N/A Satsuma Pharmaceuticals Acute treatment of migraine January 2024

 

First Generic Launches of Top Selling Brand Name Drugs in the Past Twelve Months
Generic Name Brand Name Brand Manufacturer Indication(s) Approval Date*
darunavir, tab,

600mg, 800mg

Prezista® Janssen Products HIV June 2023
topiramate cap ER 24hr, 200mg Trokendi® XR Supernus Pharmaceuticals Monotherapy epilepsy, adjunctive therapy epilepsy, migraine March 2023
teriflunomide tab, 7 mg, 14 mg+ 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,

60 mg

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

0.5 mg

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, 20 mg) 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

*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*
posaconazole IV soln

300 mg/16.7ml

(18 mg/ml)

Noxafil® (injection) Merck & Co Fungal infections June 2023
tirofiban hydrochloride Aggrastat® Medicure Ischemic heart diseases May 2023
gefitinib+ Iressa® AstraZeneca Lung cancer May 2023
budesonide rectal foam,

2 mg/act

Uceris® Bausch Health US Ulcerative colitis April 2023
posaconazole susp

40 mg/mL

Noxafil® susp Merck Sharp & Dohme Fungal infection April 2023
diltiazem hcl coated beads tab ER

24mg, 120mg

Cardizem® LA Bausch Health US Hypertension, chronic stable angina March 2023
bismuth subcit-metronidazole-tetracycline cap,

140-125-125 mg

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

5%

Zonalon® Mylan Dermatitis or eczema February 2023
epinephrine inj,

1 mg/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,

20 mg

Hetlioz® Vanda Pharmaceuticals Sleep disorders January 2023
diclofenac packet,

50 mg

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,

0.1%

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,

0.4 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, 10 mg/9 hr, 15 mg/9 hr, 20 mg/9 hr, 30 mg/9 hr Daytrana® Noven Therapeutics ADHD July 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*
pitavastatin calcium Livalo® Kowa Pharmaceuticals/Eli Lilly Dyslipidemia/primary hypercholesterolemia 2Q 2023
bendamustine hydrochloride+ Treanda® (solution) Cephalon/Teva Non-Hodgkin’s Lymphoma 2Q 2023
acetaminophen; ibuprofen Advil Dual Action® Pfizer/GSK Pain 1H 2023
prednisone Rayos® Horizon Pharma Steroid 1H 2023
uridine triacetate Xuriden® Wellstat Therapeutics Metabolic, endocrine and nutritional diseases 07/10/2023
fluorouracil Tolak® Hill Dermaceuticals/ Pierre Fabre Actinic keratoses 07/18/2023
Plerixafor+ Mozobil® Genzyme/Sanofi Non-Hodgkin’s Lymphoma 07/22/2023
cysteamine hydrochloride Cystadrops® Recordati Metabolic, endocrine and nutritional diseases 08/19/2023
stavudine Zerit XR® Bristol-Myers Squibb HIV/AIDS 08/19/2023
lisdexamfetamine dimesylate Vyvanse® (capsule) Shire/ Takeda Attention deficit hyperactivity disorder (ADHD) 08/25/2023
lisdexamfetamine dimesylate Vyvanse® (chewable tablet) Shire/ Takeda ADHD 08/25/2023
temozolomide+ Temodar® (injection) Merck & Co Brain cancer 09/08/2023
fluocinolone acetonide, hydroquinone, tretinoin Tri-Luma® Galderma Cosmetic skin agents 09/08/2023
telbivudine Tyzeka® (tablet) Novartis Hepatitis B 09/11/2023
telavancin hydrochloride Vibativ® Theravance/ Cumberland Pharmaceuticals Infections 09/11/2023
halobetasol propionate Lexette® Mayne Pharma Plaque psoriasis 09/17/2023
pazopanib hydrochloride+ Votrient® Novartis Kidney cancer 10/19/2023
dexamethasone Ozurdex® Allergan/ AbbVie Macular edema 11/01/2023
bromfenac sodium Prolensa® Bausch + Lomb/ Bausch Health/ Valeant Eye and adnexa diseases 4Q 2023
riluzole+ Tiglutik® Kit ITF Pharma/ Italfarmaco Neurodegenerative disorders 4Q 2023
teduglutide recombinant+ Gattex® NPS Pharma/ Shire/ Takeda Short bowel syndrome 2H 2023
brimonidine tartrate Alphagan P® (0.1%) Allergan/ AbbVie Glaucoma/ocular hypertension 2023
rufinamide Banzel® (100 mg tablets) Eisai Epilepsy 2023
formoterol fumarate; mometasone furoate Dulera® Merck & Co/ Organon Asthma 2023
diclofenac sodium Dyloject® Hospira/ Javelin/ Pfizer Pain 2023
ixabepilone+ Ixempra® Kit R-Pharm Breast cancer 2023
metformin hydrochloride; saxagliptin hydrochloride Kombiglyze® XR Bristol-Myers Squibb/ AstraZeneca Diabetes mellitus 2023
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Mydayis® Shire/ Takeda ADHD 2023
cyanocobalamin Nascobal® (spray) Par/ Endo Pharmaceuticals Anemia 2023
rotigotine Neupro® UCB Parkinson’s disease 2023
saxagliptin hydrochloride Onglyza® Bristol-Myers Squibb/ AstraZeneca Diabetes mellitus 2023
darunavir ethanolate Prezista® (300 mg tablets) Janssen HIV/AIDS 2023
darunavir ethanolate Prezista® (75, 150 mg tablets) Janssen HIV/AIDS 2023
tiotropium bromide Spiriva® Boehringer Ingelheim Chronic obstructive pulmonary disease (COPD) 2023
ceftaroline fosamil Teflaro® Allergan/ AbbVie Skin infections 2023
thalidomide+ Thalomid® Celgene/ Bristol-Myers Squibb Multiple myeloma 2023

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

+Specialty medication

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