Perspectives
Traditional Drug Pipeline Quarterly Update: September 2023
Critical updates in an ever-changing environment
September 25, 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 specialty drugs, biosimilars and gene/cell therapy.
New Drug Information
- No new approvals
Generic Drug Information
- Vyvanse® (lisdexamfetamine dimesylate): Multiple manufacturers have launched their generic version of Takeda’s Vyvanse capsules and chewable tablets for the treatment of attention deficit hyperactivity disorder and moderate to severe binge eating disorder in adults. Vyvanse capsules generated $4,641 million in U.S. annual sales in 2022. Vyvanse chewable tablets generated $152 million in U.S. annual sales in 2022.
- Retin-A Micro® pump (tretinoin, microsphere gel, 0.08%): Encube launched their generic version of Baush Health’s Retin-A Micro for the treatment of acne. There are no patents pending. Retin-A Micro 0.08%, together with the 0.06% strength which is not yet available generically, generated $101 million in U.S. annual sales in 2022.
- Alphagan P® (brimonidine tartrate, ophth soln, 0.1%): Apotex launched their generic version of Allergan’s Alphagan P for the treatment of glaucoma or ocular hypertension. Multiple manufacturers are expected to launch their version in 2023-2024. Alphagan P generated $234 million in U.S. annual sales in 2022.
New Indications
- Jardiance® (empagliflozin): The FDA approved Jardiance 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.
New Molecular Entity Approvals in the Past Twelve Months
| Generic Name | Brand Name | Manufacturer | Indication(s) | Date Approved*
|
| zuranolone | Zurzuvae® | Sage | Postpartum depression | August 2023 |
| lotilaner | Xdemvy® | Tarsus | Demodex blepharitis | July 2023 |
| sotagliflozin | Inpefa® | Lexicon | Heart failure | May 2023 |
| nirmatrelvir and ritonavir tablets co-packaged | Paxlovid® | Pfizer | COVID-19 | May 2023 |
| sotagliflozin | Inpefa® | Lexicon | 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 |
* 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 | RiVive® | Harm Reduction Therapeutics | Opiod overdose | July 2023 |
| cantharidin | Ycanth® | Verrica | Molluscum contagiosum | July 2023 |
| Magnesium sulfate sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, sodium sulfate | Suflave® | Braintree/Sebela | Bowel cleansing | June 2023 |
| colchicine | Lodoco® | AGEPHA Pharma USA | Reduce the risk of cardiovascular (CV) events and death in patients with established atherosclerotic disease or with multiple risk factors | 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 |
* 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* |
| valbenazine | Ingrezza® | Neurocrine Biosciences | Chorea associated with Huntington’s disease | August 2023 |
| inclisiran | Leqvio® | Novartis | LDL-C reduction in patients with primary hyperlipidemia | July 2023 |
| levonorgestrel | Liletta® | Allergan/AbbVie | Heavy menstrual bleeding | June 2023 |
| empagliflozin | Jardiance® | Eli Lilly/BI | Type 2 diabetes in children > 10 years | June 2023 |
| empagliflozin/
metformin |
Synjardy® | Eli Lilly/BI | Type 2 diabetes in children > 10 years | June 2023 |
| empagliflozin/
metformin |
Synjardy® XR | Eli Lilly/BI | Type 2 diabetes in children > 10 years | June 2023 |
| abacavir/
dolutegravir/ lamivudine |
Triumeq®/ PD | Viiv | HIV-1 in patients aged at least 3 months and weighing at least 6 kg | June 2023 |
| 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
Pipeline Watch
| Generic Name | Brand Name | Manufacturer | Indication(s) | Anticipated FDA Decision Date |
| brimonidine tartrate ophthalmic | N/A | Visiox/ Sun Pharma Advanced Research Company | Glaucoma | 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 | Nyxol® | Ocuphire/ Viatris | Mydriasis | September 2023 |
| tenapanor | Xphozah® | Ardelyx | For control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. | October 2023 |
| pilocarpine hydrochloride ophthalmic | 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 |
| roluperiodone | N/A | Minerva | Schizophrenia | October 2023 |
| ITCA 650
(exenatide, SC minipump) |
N/A | Intarcia | Type 2 diabetes | 2023 |
| reproxalap | N/A | Aldeyra Therapeutics | Dry eye disease | November 2023 |
| taurolidine, heparin and citrate | N/A | CorMedix | Catheter-related infection prevention | November 2023 |
| vonoprazan | N/A | Phathom | Heartburn | November 2023 |
| roflumilast foam | N/A | Arcutis biotherapeutics | Seborrheic dermatitis | December 2023 |
| gefapixant | N/A | Merck | Chronic cough | December 2023 |
| aprocitentan | N/A | Idorsia | Resistant hypertension | December 2023 |
| STS101 (dihydroergotamine nasal powder) | N/A | Satsuma Pharmaceuticals | Acute treatment of migraine | January 2024 |
| berdazimer gel | N/A | Novan & Ligand | Molluscum contagiosum | January 2024 |
| scopolamine | N/A | Defender | Prevent motion nausea/vomiting | January 2024 |
| cefepime and taniborbactam | N/A | Venatorx and Everest | Complicated urinary tract infections (cUTI) | February 2024 |
| Exblifep™ (cefepime and enmatazobactam) | N/A | Allecra | cUTI | February 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* |
| brimonidine tartrate,
ophth soln, 0.1% |
Alphagan P® | Allergan
|
Glaucoma or ocular hypertension | September 2023 |
| tretinoin, microsphere gel, 0.08% | Retin-A
Micro® pump |
Baush Health | Acne | September 2023 |
| lisdexamfetamine dimesylate, capsules and chewable tablets
|
Vyvanse® | Shire | Attention deficit hyperactivity disorder or binge eating disorder | September 2023 |
| tiotropium inhal cap,
18 mcg |
Spiriva® Handihaler | BI | COPD | August 2023 |
| saxagliptin-metformin, tab ER 24hr,
2.5-1000 mg, 5-500 mg, 5-1000 mg |
Kombiglyze™ XR | Astrazeneca | Type 2 Diabetes | August 2023 |
| budesonide-formoterol fumarate dihyd aerosol
80-4.5 mcg/act, 160-4.5 mcg/act |
Symbicort® | Astrazeneca | Asthma; Chronic obstructive pulmonary disease | August 2023 |
| saxagliptin, tab,
2.5 mg, 5 mg |
Onglyza® | Astrazeneca | Type 2 diabetes mellitus | August 2023 |
| 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 |
*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* |
| levonorgestrel-ethinyl estradiol-fe tab,
0.1 mg-20 mcg (21) |
Balcoltra® | Avion | Pregnancy prevention | August 2023 |
| calcipotriene cream & dressing kit,
0.005% |
Trionex® | V2 Pharma | Plaque psoriasis | August 2023 |
| Plerixafor inj, 24 mg/ 1.2 mL | Mozobil® | Sanofi | Certain forms of non-Hodgkin’s lymphoma and multiple myeloma | July 2023 |
| tirofiban/nacl IV soln,
5 mg/100 mL-0.9%, 12.5 mg/250 mL-0.9% |
Aggrastat® | Medicure | Reduce the rate of thrombotic cardiovascular events in patients with non-ST elevation acute coronary syndrome | July 2023 |
| baclofen susp, 25 mg/5 mL | Fleqsuvy® | Azurity | Spasiticity from multiple sclerosis | June 2023 |
| 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,
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 |
*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 Year* |
| Fluticasone propionate | Flovent® HFA | GSK | Asthma | 2023 |
| pitavastatin calcium | Livalo® | Kowa Pharmaceuticals/Eli Lilly | Dyslipidemia/primary hypercholesterolemia | 2023 |
| pazopanib hydrochloride+ | Votrient® | Novartis | Kidney cancer | 2023 |
| prednisone | Rayos® | Horizon Pharma | Anti-inflammatory/
immunosuppressive |
2023 |
| dexamethasone | Ozurdex® | Allergan/ AbbVie | Macular edema | 2023 |
| bromfenac sodium | Prolensa® | Bausch + Lomb/ Bausch Health/ Valeant | Eye and adnexa diseases | 2023 |
| teduglutide recombinant+ | Gattex® | NPS Pharma/ Shire/ Takeda | Short bowel syndrome | 2023 |
| formoterol fumarate; mometasone furoate | Dulera® | Merck & Co/ Organon | Asthma | 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 |
| 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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