Traditional Drug Pipeline Quarterly Update: September 2023

Critical updates in an ever-changing environment

September 25, 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

  • 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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