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
- Zavzpret® (zavegepant): The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Zavzpret for the acute treatment of migrainewith or without aura in adults. Zavzpret is the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray. Zavzpret was approved based on the Phase 3 study that demonstrated Zavzpret was statistically superior to placebo on the two co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) at two hours post-dose. Twenty-two percent of patients treated with Zavzpret 10mg and 23% of patients treated with Zavzpret 20mg were pain free after dosing compared to 15.5% of patients treated with placebo. Almost half of patients (10mg: 41.9%, 20mg: 42.5%) treated with Zavzpret were free from MBS at two hours after receiving treatment compared to 22.7% of patients treated with placebo.1 Zavzpret will be available July 2023 with pricing to follow.
Generic Drug Information
- Zonalon® (doxepin hcl cream 5%): Teva launched their generic version of Mylan’s Zonalon for the short-term (up to eight days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. Zonalon cream generated less than $10 million in U.S. annual sales in 2022.
- Aubagio® (teriflunomide 7mg, 14mg)+: Multiple manufacturers have launched their generic versions of Sanofi/Genzyme’s Aubagio indicated for the treatment of patients with relapsing forms of multiple sclerosis. Additional manufacturers are scheduled to launch their versions this year. Aubagio generated $2,009 million in U.S. annual sales in 2022.
- Pylera® (bismuth subcit-metronidazole-tetracycline cap140-125-125 mg): Par Pharmaceuticals launched their generic version of Allergan’s Pylera indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past five years) to eradicate H. pylori. Also indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of Pylera and other antibacterial drugs, Pylera should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Pylera generated $42 million in U.S. annual sales in 2022.
+Specialty medication
References
New Molecular Entity Approvals in the Past Twelve Months
| Generic Name | Brand Name | Manufacturer | Indication(s) | Date Approved*
|
| 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 |
| 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 |
* 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 | 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 |
| 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 |
* 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 |
| tenapanor | Xphozah® | Ardelyx | For control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. | 2023 |
| rezafungin | N/A | Cidara/ Melinta | Antifungal | March 2023 |
| rizatriptan, oral film | Rizafilm® | IntelGenx/ Gensco | Migraine | April 2023 |
| letibotulinumtoxinA | N/A | Hugel America | Frown lines | April 2023 |
| aripiprazole two-month, ready-to-use injectable | N/A | Otsuka/ Lundbeck | Bipolar | April 2023 |
| naloxone 3mg nasal spray | RiVive® | Harm Reduction Therapeutics | Opioid overdose | April 2023 |
| sotagliflozin | Zynquista® | Lexicon Pharmaceuticals | Heart failure | May 2023 |
| fezolinetant | N/A | Astellas | Vasomotor symptoms (VMS) associated with menopause | May 2023 |
| buprenorphine depot | Brixadi® | Braeburn Pharmaceutical | Opioid overdose | May 2023 |
| sulbactam/ durlobactam | N/A | Innoviva (Entasis) | Infection | May 2023 |
| phenylephrine/ tropicamide | MydCombi® | Eyenovia | Mydriasis | May 2023 |
| clotrimazole, otic | N/A | Salvat Laboratories | Otomycosis | June 2023 |
| olorofim | N/A | F2G | Antifungal | June 2023 |
| gepirone extended release | Exxua | Fabre-Kramer | Major depressive disorder | June 2023 |
| NOV03 (perfluorohexyloctane) | N/A | Bausch + Lomb Corporation | Dry eye disease | June 2023 |
| IPX203 (carbidopa/ levodopa) | N/A | Amneal Pharmaceuticals | Parkinson’s disease | June 2023 |
| cyclosporine ophthalmic solution | CyclASol® | Novaliq | Dry eye 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 |
| CSF1 (low dose pilocarpine hydrochloride 0.4%) | N/A | Orasis Pharmaceuticals | Improve near vision for people with presbyopia | October 2023 |
| reproxalap | N/A | Aldeyra Therapeutics | Dry eye disease | November 2023 |
| OX124 (naloxone, nasal) | N/A | Orexo | Opioid overdose | December 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* |
| teriflunomide tab,
7mg, 14mg+ |
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,
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,
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,
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, 801mg |
Esbriet® | Genentech | Idiopathic pulmonary fibrosis (IPF) | May 2022 |
| bortezomib inj,
3.5mg+ |
Velcade® | Takeda Pharmaceuticals | Multiple myeloma, mantle cell lymphoma | May 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* |
| bismuth subcit-metronidazole-tetracycline cap,
140-125-125mg |
Pylera® | Allergan | Helicobacter pylori infection and duodenal ulcer disease | March 2023 |
| doxepin hcl cream,
5% |
Zonalon® | Mylan | Dermatitis or eczema | February 2023 |
| epinephrine inj,
1mg/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,
20mg |
Hetlioz® | Vanda Pharmaceuticals | Sleep disorders | January 2023 |
| diclofenac packet,
50mg |
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,
0.25mg/0.25 gm (0.1%), 0.5mg/0.5 gm (0.1%), 0.75mg/0.75 gm (0.1%), 1mg/gm (0.1%), 1.25 mg/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, 500 mg | Pentasa®
500 mg |
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 |
*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* |
| teduglutide recombinant+ | Gattex® | NPS Pharma | Short bowel syndrome | March 2023 |
| tirofiban hydrochloride | Aggrastat® | Medicure | Ischemic Heart Diseases | March 2023 |
| posaconazole | Noxafil® (injection) | Merck &Co | Fungal infection | 1Q 2023 |
| prednisone | Rayos® | Horizon Pharma | Steroid | 1Q 2023 |
| bendamustine hydrochloride+ | Treanda® (solution) | Cephalon | Leukemia | 1Q 2023 |
| gefitinib+ | Iressa® | AstraZeneca | Lung cancer | 1H 2023 |
| brimonidine tartrate | Alphagan P® (0.1%) | Allergan | Glaucoma/ocular hypertension | 2023 |
| rufinamide | Banzel® (100mg tablets) | Eisai | Epilepsy | 2023 |
| formoterol fumarate; mometasone furoate | Dulera® | Merck &Co | Asthma | 2023 |
| diclofenac sodium | Dyloject® | Hospira | Pain | 2023 |
| metformin hydrochloride; saxagliptin hydrochloride | Kombiglyze® XR | BMS | Diabetes | 2023 |
| cyanocobalamin | Nascobal® (spray) | Par | Anemia | 2023 |
| rotigotine | Neupro® | UCB | Parkinson’s disease | 2023 |
| saxagliptin hydrochloride | Onglyza® | BMS | Diabetes | 2023 |
| darunavir ethanolate | Prezista® (300 mg tablets) | Janssen | HIV | 2023 |
* Expected to market dates are predictions made by Prime Therapeutics based on industry information.
+Specialty medication
Loading …