Traditional Drug Pipeline Quarterly Update: December 2022

Critical updates in an ever changing environment

December 29, 2022

This quarterly 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, cell/gene therapies and biosimilars.

New Drug Information

  • Sezaby® (phenobarbital sodium): The U.S. Food and Drug Administration (FDA) has approved Sun Pharma and Sun Pharma Advanced Research Co (SPARC) Sezaby, as a new benzyl alcohol-free and propylene glycol-free formulation of the phenobarbital sodium for injection for treatment of neonatal seizures in term and preterm infants. Sezaby was approved via the 505(b)2 pathway using phenobarbital as its reference product.1 Sezaby is scheduled to be available in the fourth quarter of 2023 with price to follow.
  • Jylamvo® (methotrexate): The FDA approved Therakind’s Jylamvo, an oral solution containing 2mg/mL, indicated for active rheumatoid arthritis in adult patients, polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non‑steroidal anti‑inflammatory drugs (NSAIDs) has been inadequate. Also for severe, treatment‑refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. Lastly, maintenance treatment of acute lymphoblastic leukemia (ALL) in adults, adolescents and children aged 3 years and over. Jylamvo was approved via the 505(b)2 pathway using methotrexate as its reference product.2 Jylamvo launch and price are pending.

Generic Drug Information

  • Denavir® cream (penciclovir cream, 1%): Teva has launched their generic of Mylan’s Denavir cream for treatment of herpes. Denavir cream generated $28 million in U.S. annual sales in 2021.
  • Zioptan® (tafluprost preservative free (pf) ophth soln, 0.0015%): Micro Laboratories has launched their generic version of Thea Pharma’s Zioptan which is indicated to reduce elevated intraocular pressure. Zioptan generated $42 million in U.S. annual sales in 2021.
  • Dexilant® (dexlansoprazole capsule delayed release 60mg): Par Pharmaceutical’s launched their generic version of Takeda Pharmaceuticals’ Dexilant® (dexlansoprazole cap delayed release, 60mg). Dexilant is indicated for healing of all grades of erosive esophagitis (EE), maintaining healing of EE and relief of heartburn and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). Multiple manufacturers are planning to launch their generic versions following Par Pharmaceuticals launch. Dexilant generated $1.103 billion in U.S. annual sales in 2021.

+Specialty medication

References

  1. https://www.empr.com/home/news/sezaby-approved-to-treat-seizures-in-term-and-preterm-infants/
  2. https://www.therakind.com/jylamvo
NEW MOLECULAR ENTITY APPROVALS IN THE PAST TWELVE MONTHS
Generic Name Brand Name Manufacturer Indication(s) Date Approved*

 

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
daridorexant Quviviq® Idorsia Insomnia January 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*
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
dextroamphetamine transdermal system (ATS) Xelstrym® Noven Therapeutics ADHD March 2022
donepezil, transdermal Adlarity® Corium Alzheimer’s disease March 2022
levothyroxine sodium Ermeza™ Mylan/Viatris Hypothyroidism May 2022
amlodipine oral solution Norliqva® CMP Pharma, Inc. Hypertension February 2022
baclofen Fleqsuvy® Azurity Pharmaceuticals Spasticity associated with multiple sclerosis February 2022
mometasone furoate and olopatadine hydrochloride Ryaltris nasal spray® Glenmark Pharmaceuticals Seasonal allergic rhinitis January 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
lenacapavir N/A Gilead Sciences HIV December 2022
PT027 (albuterol and budesonide) N/A Avillion and AstraZeneca Asthma January 2023
fezolinetant N/A Astellas Vasomotor symptoms (VMS) associated with menopause February 2023
omecamtiv mecarbil N/A Cytokinetics Heart failure with reduced ejection fraction February 2023
ABBV-951 (foscarbidopa and foslevodopa) N/A AbbVie Parkinson’s disease March 2023
rezafungin N/A Cidara and Melinta Antifungal March 2023
zavegepant N/A Biohaven (Pfizer to acquire) Migraine March 2023
letibotulinumtoxinA N/A Hugel America Frown lines April 2023
sotagliflozin Zynquista® Lexicon Pharmaceuticals Heart failure May 2023
aripiprazole 2-month, ready-to-use injectable N/A Otsuka and Lundbeck Bipolar May 2023
NOV03 (perfluorohexyloctane) N/A Bausch + Lomb Corporation Dry eye disease June 2023
IPX203 (carbidopa and levodopa) N/A Amneal Pharmaceuticals, Inc Parkinson’s disease June 2023
cyclosporine ophthalmic solution CyclASol® Novaliq Dry eye disease June 2023
sofpironium bromide N/A Botanix Pharmaceuticals and Brickell Biotech Primary axillary hyperhidrosis September 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*
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,

75mg, 150mg

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, 80mg

Esbriet® Genentech Idiopathic pulmonary fibrosis (IPF) May 2022
bortezomib inj,

3.5mg+

Velcade® Takeda Pharmaceuticals Multiple myeloma, mantle cell lymphoma May 2022
lacosamide tab,

50mg, 100mg,

150mg, 200mg

Vimpat® tab,

50mg, 100mg, 150mg, 200mg

UCB Pharma Partial-onset seizures; primary generalized tonic-clonic seizures March 2022
lenalidomide+ Revlimid® (5, 10, 15, 25mg) Celgene/ BMS Non-Hodgkin’s lymphoma March 2022
cyclosporine ophthalmic emulsion,

0.05%

Restasis® Allergan Increase tear production due to ocular inflammation associated with keratoconjunctivitis sicca February 2022
vasopressin inj,

20 unit/mL

Vasostrict® Par Sterile Products Increase blood pressure January 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*
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%),

1.25mg/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, 500mg Pentasa®

500mg

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
diclofenac cap,

25mg

Zipsor cap®,

25mg

Assertio Therapeutics Relief of mild to moderate acute pain March 2022
tolvaptan tab,

15mg

Samsca tab®         (15mg) Otsuka America Hypervolemic and

euvolemic hyponatremia

March 2022
apomorphine inj, +

30mg/3 mL

Apokyn® Supernus Pharmaceuticals Parkinson’s disease March 2022
carbidopa/levodopa/

entacapone tabs,

12.5-50-200mg,

18.75-75-200mg,

25-100-200mg,

31.25-125-200mg,

37.5-150-200mg,

50-200-200mg

Stalevo® Almatica Parkinson’s disease March 2022
amphotericin b liposome IV for susp, 50mg Ambisome® Astellas Fungal infections February 2022
deferiprone tab,

1000mg

Ferriprox® Chiesi USA Chronic iron overload February 2022
digoxin tab,

62.5 mcg

Lanoxin® Concordia Pharmaceuticals Heart failure, atrial fibrillation February 2022
maraviroc tabs,

150mg, 300mg

Selzentry® Viiv Healthcare HIV February 2022
betaine powder for oral soln Cystadane® Recordati Rare Diseases Homocystinuria February 2022
romidepsin for inj,

10mg

Istodax® B-M Squibb U.S. Certain forms of cutaneous T-cell lymphoma (CTCL) January 2022
glycopyrrolate oral soln,

1mg/5 mL

Cuvposa® Merz Pharmaceuticals Severe drooling associated with neurologic conditions January 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*
prednisone Rayos® Horizon Pharma Autoimmune 12/2022
gefitinib+ Iressa® AstraZeneca Lung cancer 2022
rufinamide Banzel® (100mg tablets) Eisai Epilepsy 2022
sodium oxybate+ Xyrem® Jazz Pharmaceuticals Sleep 2022
enalapril maleate Epaned KIT® Silvergate Hypertension 2022
ritonavir Norvir® (capsules) AbbVie HIV 2022
benzoyl peroxide; clindamycin phosphate Onexton® Dow Pharmaceutical Sciences Acne 2022
oxycodone hydrochloride Oxaydo® Egalet Pain 2022
octreotide acetate+ Sandostatin® LAR Novartis Endocrine gland diseases 2022
thalidomide+ Thalomid® Celgene Leprosy 2022
rotigotine Neupro® UCB Parkinson’s disease 2023
pirfenidone+ Esbriet® (capsule) InterMune/ Genentech Respiratory system diseases 2023
darunavir ethanolate Prezista® Janssen HIV 2023
tiotropium bromide Spiriva® Boehringer Ingelheim COPD 2023
ethinyl estradiol; levonorgestrel Balcoltra® Avion Pharmaceuticals Pregnancy prevention 2023-2024
fluticasone propionate Flovent HFA® GSK Asthma 2022-2025

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

+Specialty medication

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