Perspectives
Traditional Drug Pipeline Quarterly Update: June 2022
Critical updates in an ever changing environment
July 12, 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
- Vtama® (tapinarof cream, 1%): The U.S. Food and Drug Administration (FDA) has approved Dermavant Sciences’ Vtama (tapinarof) cream, 1%, indicated for the topical treatment of plaque psoriasis in adults. Vtama cream is the first in a new class, aryl hydrocarbon receptor (AhR) agonists. Vtama’s approval was based on two Phase 3 studies, PSOARING1 and PSOARING2 which found 36% and 40% of patients treated with tapinarof cream met the primary endpoint of clear or almost clear based on the Physician Global Assessment (PGA) score compared to 6% and 6% for treatment with vehicle.1 Vtama has launched with a wholesale acquisition cost (WAC) of $1,325 per 60 gram tube.
Generic Drug Information
- Alimta®+ (pemetrexed injection 100mg, 500mg): Multiple manufacturers have launched their generic version of Eli Lilly’s Alimta® (premetrexed disodium), a folate analog metabolic inhibitor indicated for:
- Locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC)
- Initial treatment in combination with pembrolizumab and platinum chemotherapy
- Initial treatment in combination with cisplatin
- Maintenance treatment of patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
- After prior chemotherapy as a single agent
- Mesothelioma: in combination with cisplatin
- Locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC)
There are no remaining legal or regulatory barriers and multiple manufactures are planning to launch their generic versions this year. Alimta generated $1.641 billion in U.S. annual sales in 2021.
- Targretin®+ (bexarotene gel 1%): Multiple manufacturers have launched their generic version of Bausch Health’s Targretin for skin problems arising from a disease called cutaneous T-cell lymphoma, or CTCL, in patients who have not responded well to other treatments. Targretin gel generated $26 million in U.S. annual sales in 2021.
- Nexavar®+ (sorafenib tab, 200mg): Dr. Reddy’s and Mylan have launched their generic version of Bayer Healthcare Pharma’s Nexavar indicated for hepatocellular carcinoma, renal cell carcinoma, differentiated thyroid carcinoma. Naxavar generated $170 million in U.S. annual sales in 2021.
- Viibryd®+ (vilazodone): Multiple manufacturers have launched their generic version of Allergan’s Viibryd for major depressive disorder. Viibryd generated $603 million in U.S. annual sales in 2021.
+Specialty medication
NEW MOLECULAR ENTITY APPROVALS IN THE PAST TWELVE MONTHS
| Generic name | Brand name | Manufacturer | Indication(s) | Date approved* | |
| 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 | |
| maribavir | Livtencity™ | Takeda | Cytomegalovirus (CMV) infection | November 2021 | |
| difelikefalin | Korsuva® | Cara Therapeutics | Chronic kidney disease-associated pruritis (CKD-aP) in hemodialysis patients | August 2021 | |
| fexinidazole | N/A | Sanofi | Trypanosoma brucei gambiense form of sleeping sickness | July 2021 | |
| finerenone | Kerendia® | Bayer | Chronic kidney disease (CKD) and type 2 diabetes | July 2021 | |
* 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* | |
| 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 | |
| glycopyrrolate orally disintegrating tablets | Dartisla ODT™ | Edenbridge Pharmaceuticals | Peptic ulcer | December 2021 | |
| tadalafil/finasteride | Entadfi™ | Veru | Benign prostatic hyperplasia | December 2021 | |
| baclofen oral granules | Lyvispah® | Saol | Spasticity resulting from multiple sclerosis | December 2021 | |
| clindamycin 2% hydrogel | Xaciato® | Daré Bioscience | Bacterial vaginosis | December 2021 | |
| topiramate oral solution,
25mg/mL |
Eprontia® | Azurity Pharmaceuticals | Seizures | November 2021 | |
| pilocarpine HCL
ophthalmic solution 1.25% |
Vuity® | Allergan | Presbyopia | October 2021 | |
| tramadol 44mg and celecoxib 56mg tablet | Seglentis® | Esteve Pharmaceuticals and Kowa Pharmaceuticals America | Pain | October 2021 | |
| varenicline nasal spray | Tyrvaya® | Oyster Point Pharma | Dry eye disease | October 2021 | |
| naloxone pre-filled syringe | Zimhi® | Adamas Pharma | Opioid overdose | October 2021 | |
| atogepant | Qulipta® | AbbVie | Preventive treatment of migraine | September 2021 | |
| paliperidone palmitate extended-release injectable suspension | Invega Hafyera® | Janssen Pharmaceuticals, Inc. | Schizophrenia | September 2021 | |
| dihydroergotamine mesylate, DHE | Trudhesa® | Impel Neuropharma | Migraine | September 2021 | |
| benzoyl peroxide and tretinoin | Twyneo® | Sol-Gel Technologies | Acne vulgaris | July 2021 | |
* 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* | |
| ET-104 (zonisamide oral suspension) | N/A | Azurity Pharmaceuticals | Anticonvulsant | Delayed | |
| AXS-05 (dextromethorphan and bupropion) | N/A | Axsome Therapeutics | Major depressive disorder | Delayed | |
| reltecimod | N/A | Atox Bio | Necrotizing soft tissue infection | Delayed | |
| testosterone undecanoate | Kyzatrex® | Marius Pharmaceuticals | Hypogonadism | Delayed | |
| diazepam buccal film | Libervant™ | Aquestive Therapeutics | Seizures | Delayed | |
| dihydroergotamine (DHE) autoinjector | N/A | Amneal | Acute migraine | Delayed | |
| letibotulinumtoxinA | N/A | Hugel America | Frown lines | Delayed | |
| udenafil | N/A | Mezzion Pharma | Single ventricle heart disease (SVHD) who have undergone the Fontan operation | Delayed | |
| tebipenem pivoxil hydrobromide | N/A | Spero Therapeutics | Complicated urinary tract infections (cUTI), including pyelonephritis | June 2022 | |
| roflumilast cream (ARQ-151) | N/A | Arcutis Biotherapeutics, Inc. | Plaque psoriasis | July 2022 | |
|
taurolidine, heparin and citrate
|
Defencath®
|
Cormedix Inc | Prevention of certain catheter-related bloodstream infection | August 2022 | |
| paracetamol and ibuprofen solution for infusion | Maxigesic® IV | Hyloris Pharmaceuticals SA | Postoperative pain | September 2022 | |
| linzagolix | N/A | ObsEva | Uterine fibroids | September 2022 | |
| HTX-019 (aprepitant) | N/A | Heron Therapeutics | Prevention of postoperative nausea and vomiting | September 2022 | |
| omecamtiv mecarbil | N/A | Cytokinetics | Heart failure with reduced ejection fraction | November 2022 | |
| PT027 (albuterol and budesonide) | N/A | Avillion and AstraZeneca | Asthma | January 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* | |
| 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 | |
| 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 | |
| naloxone hydrochloride | Narcan® (nasal spray) | Adapt Pharma | Opioid overdose | December 2021 | |
| adapalene; benzoyl peroxide | Epiduo Forte® | Galderma | Acne vulgaris | December 2021 | |
| zolmitriptan nasal spray, 5mg/spray | Zomig® nasal spray | AstraZeneca | Migraine headache | November 2021 | |
| everolimus+ | Afinitor® (10mg) | Novartis | Kidney cancer | October 2021 | |
| everolimus+ | Afinitor® Disperz | Novartis | Certain forms of cancer | October 2021 | |
| difluprednate ophth emulsion, 0.05% | Durezol® | Novartis | Endogenous anterior uveitis | September 2021 | |
| nebivolol | Bystolic® | Allergan | Hypertension | September 2021 | |
| sunitinib malate+ | Sutent® | CPPI CV | Cancer | August 2021 | |
| ibuprofen/famotidine | Duexis® | Horizon Therapeutics USA | Rheumatoid arthritis (RA), osteoarthritis (OA), ulcers | August 2021 | |
| ferumoxytol | Feraheme® | AMAG Pharmaceuticals | Anemia | July 2021 | |
*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* |
| 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 |
| clocortolone cream, 0.1% | Cloderm® | EPI Health | Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses | December 2021 |
| nelarabine inj, 5mg/mL+ | Arranon® | Novartis | Certain forms of T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma | November 2021 |
| everolimus tab, 1mg | Zortress® | Novartis | Prophylaxis of organ rejection in certain transplantations | November 2021 |
| enalapril oral soln, 1mg/mL | Epaned® | Azurity Pharmaceuticals | Heart failure, hypertension | August 2021 |
| buprenorphine buccal film | Belbuca® | Biodelivery Sciences | Pain management | August 2021 |
| atropine prefilled syringe inj, 0.25mg/5 mL (0.05mg/mL) | N/A | Hospira | Temporary blockade of severe or life-threatening muscarinic effects | August 2021 |
| argatroban | Argatroban® | Hikma | Heparin-induced thrombocytopenia (HIT) | July 2021 |
*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.
GENERICS OF TOP SELLING BRAND DRUGS POTENTIALLY AVAILABLE SOON
| Generic name | Brand name | brand Manufacturer | Indication(s) | To market date* | |
| rufinamide | Banzel® (100mg tablets) | Eisai | Epilepsy | June 2022 | |
| vandetanib+ | Caprelsa® | AstraZeneca | Thyroid cancer | June 2022 | |
| methylphenidate | Daytrana® | Noven Pharmaceuticals | ADHD | 2Q 2022 | |
| dabigatran etexilate mesylate | Pradaxa® (capsules) | Boehringer Ingelheim | Atrial fibrillation | 2Q 2022 | |
| lacosamide | Vimpat® (oral solution) | UCB | Epilepsy | 2Q 2022 | |
| oxycodone hydrochloride | Oxaydo® | Egalet | Pain | 1H 2022 | |
| sodium oxybate+ | Xyrem® | Jazz Pharmaceuticals | Sleep | 2H 2022 | |
| ethinyl estradiol; levonorgestrel | Balcoltra® | Avion Pharmaceuticals | Pregnancy prevention | 2022 | |
| enalapril maleate | Epaned KIT® | Silvergate | Hypertension | 2022 | |
| fluticasone propionate | Flovent HFA® | GSK | Asthma | 2022 | |
| cabazitaxel+ | Jevtana® Kit | Sanofi | Prostate cancer | 2022 | |
| rotigotine | Neupro® | UCB | Parkinson’s disease | 2022 | |
| ritonavir | Norvir® (capsules) | AbbVie | HIV | 2022 | |
| benzoyl peroxide; clindamycin phosphate | Onexton® | Dow Pharmaceutical Sciences | Acne | 2022 | |
| lenalidomide+ | Revlimid® (2.5, 20mg) | Celgene | Myelodysplastic syndromes | 2022 | |
| octreotide acetate+ | Sandostatin® LAR | Novartis | Endocrine gland diseases | 2022 | |
| bexarotene+ | Targretin® (gel) | Valeant | Non-Hodgkin’s Lymphoma | 2022 | |
| thalidomide | Thalomid® | Celgene | Leprosy | 2022 | |
| fesoterodine fumarate | Toviaz® | Pfizer | Overactive bladder | 2022 | |
| tafluprost | Zioptan® | Akorn | Glaucoma or ocular hypertension | 2022 | |
* Expected to market dates are predictions made by Prime Therapeutics based on industry information.
+Specialty medication
REFERENCES
- https://www.globenewswire.com/news-release/2022/05/24/2449068/34323/en/FDA-Approves-Dermavant-s-VTAMA-tapinarof-cream-1-for-the-Treatment-of-Plaque-Psoriasis-in-Adults-First-Topical-Novel-Chemical-Entity-Launched-for-Psoriasis-in-the-U-S-in-25-Years.html
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