Perspectives
Traditional Drug Pipeline Quarterly Update: December 2022
Critical updates in an ever changing environment
December 29, 2022This 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
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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