Perspectives
Traditional Drug Pipeline Quarterly Update: June 2023
Critical updates in an ever-changing environment
June 22, 2023This 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
- https://www.empr.com/home/news/fda-approves-inpefa-for-the-treatment-of-heart-failure/
- 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/
- 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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