Perspectives
Traditional Drug Pipeline Update: March 2022
Critical updates in an ever changing environment
March 29, 2022New drugs, new indications and news of note
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 article for pipeline information on specialty drugs.
New Drug Information
Norliqva™ (amlodipine besylate): The U.S. Food and Drug Administration (FDA) has approved CMP Pharma’s Norliqva (amlodipine besylate) an oral solution formulation of the approved calcium channel blocker amlodipine for the treatment of hypertension in adults and children six years and older, to lower blood pressure and coronary artery disease [chronic stable angina, vasospastic angina (Prinzmetal’s or variant angina) and angiographically documented coronary artery disease in patients without heart failure or an ejection fraction <40%.] Norliqva was approved via the 505(b)(2) pathway using Pfizer’s Norvasc (amlodipine oral tablets) as a reference product.1 Norliqva is supplied as a peppermint flavored oral solution containing 1mg/mL amlodipine as the besylate salt. It is administered once daily. Amlodipine is also available as an oral suspension in Azurity’s Katerzia. Norliqva launch and price are pending.
Generic Drug Information
Revlimid®+ (lenalidomide) 5, 10, 15, 25mg: Teva has launched their generic version of Bristol-Myers Squibb’s Revlimid 5, 10, 15, 25mg tablets. Revlimid is a thalidomide analogue indicated for the treatment of patients with:
-
- Multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy
- Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities
- Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib
Teva is eligible for 180-day exclusivity for those four strengths. Thirteen more manufacturers are scheduled to launch in August of 2022. Revlimid 5,10, 15, 25mg generated $10,054 million in U.S. annual sales in 2021.
Apokyn®+ (apomorphine inj 30mg/3mL): TruPharma launched their version of Supernus Pharmaceuticals’ Apokyn for the treatment of Parkinson’s disease. Apokyn generated $69 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* |
| 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 |
| brincidofovir | Tembexa® | Chimerix | Smallpox | June 2021 |
| ibrexafungerp | Brexafemme® | Scynexis | Antifungal | June 2021 |
| olanzapine and samidorphan | Lybalvi® | Alkermes | Schizophrenia or bipolar I disorder | June 2021 |
| estetrol and drospirenone (E4/DRSP) | Nextstellis™ | Mayne Pharma, Mithra Pharmaceuticals | Pregnancy prevention | April 2021 |
| viloxazine hydrochloride | Qelbree™ | Supernus Pharmaceuticals | ADHD | April 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* |
| 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,
25 mg/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 |
| torsemide | Soaanz® | Sarfez Pharmaceuticals | Edema caused by heart failure | June 2021 |
| cyclosporine ophthalmic emulsion | Verkazia™ | Santen | Vernal keratoconjunctivitis | June 2021 |
| ephedrine injection | Rezipres® | Eton Pharmaceuticals | Hypotension | June 2021 |
| semaglutide | Wegovy™ | Novo Nordisk | Chronic weight management | June 2021 |
| relugolix, estradiol and norethindrone | Myfembree™ | Myovant (Sumitomo Dainippon) | Heavy menstrual bleeding | June 2021 |
| bupivacaine and meloxicam extended-release solution | Zynrelef™ | Heron Therapeutics | Postoperative pain | May 2021 |
| naloxone hydrochloride nasal spray | Kloxxado™ | Hikma Pharmaceuticals | Emergency treatment of known or suspected opioid overdose | April 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 |
| benzoyl peroxide | Epsolay™ | Sol-Gel Technologies | Rosacea | Delayed |
| 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 |
| dextroamphetamine transdermal system (ATS) | N/A | Noven Therapeutics | ADHD | Delayed |
| diazepam buccal film | Libervant™ | Aquestive Therapeutics | Seizures | Delayed |
| oteseconazole (VT-1161) | N/A | Mycovia Pharmaceuticals | Vulvovaginal candidiasis | Delayed |
| dihydroergotamine (DHE) autoinjector | N/A | Amneal | Acute migraine | Delayed |
| letibotulinumtoxinA | N/A | Hugel America | Frown lines | March 2022 |
| udenafil | N/A | Mezzion Pharma | Single ventricle heart disease (SVHD) who have undergone the Fontan operation | March 2022 |
| donepezil, transdermal | Adlarity® | Corium | Alzheimer’s disease | March 2022 |
| meloxicam-rizatriptan | MoSEIC™ | Axsome Therapeutics | Acute migraine | April 2022 |
| BXCL501 (dexmedetomidine orally dissolving film) | N/A | BioXcel Therapeutics | Schizophrenia and bipolar disorders | April 2022 |
| cantharidin 0.7% topical solution | Ycanth® | Verrica Pharmaceuticals | Molluscum contagiosum | May 2022 |
| tapinarof (DMVT-505) | N/A | Dermavant (Roivant) | Plaque psoriasis | May 2022 |
| vonoprazan | N/A | Phathom Pharmaceuticals | Triple therapy for Helicobacter pylori | May 2022 |
| vonoprazan | N/A | Phathom Pharmaceuticals | Dual therapy for Helicobacter pylori | May 2022 |
| tirzepatide | N/A | Lilly | Type 2 diabetes | June 2022 |
| tebipenem pivoxil hydrobromide | N/A | Spero Therapeutics | Complicated urinary tract infections (cUTI), including pyelonephritis | June 2022 |
| paracetamol and ibuprofen solution for infusion | Maxigesic® IV | Hyloris Pharmaceuticals SA | Postoperative pain | September 2022 |
| linzagolix | N/A | ObsEva | Uterine fibroids | September 2022 |
| omecamtiv mecarbil | N/A | Cytokinetics | Heart failure with reduced ejection fraction | November 2022 |
* Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.
FIRST GENERIC LAUNCHES OF TOP SELLING BRAND NAME DRUGS IN THE PAST TWELVE MONTHS
| Generic Name | Brand Name | Brand Manufacturer | Indication(s) | Approval Date* |
| 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 |
| formoterol fumarate | Perforomist® | Mylan | COPD | June 2021 |
| arformoterol tartrate | Brovana® | Sunovion | COPD | June 2021 |
| rufinamide | Banzel® | Eisai | Seizures associated with Lennox-Gastaut Syndrome | June 2021 |
| isotretinoin | Absorica® | Ranbaxy | Acne | May 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* |
| apomorphine inj, +
30 mg/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,
62.5mcg |
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/5mL |
Cuvposa® | Merz Pharmaceuticals | Severe drooling associated with neurologic conditions | January 2022 |
| clocortolone crm, 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/5mL (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 |
| etravirine | Intelence® | Janssen | HIV | June 2021 |
| lopinavir, ritonavir | Kaletra® | AbbVie | HIV | June 2021 |
| bepotastine ophth soln, 1.5% | Bepreve® | Bausch Health | Allergic conjunctivitis | June 2021 |
| tiopronin tab | Thiola® | Travere Therapeutics | Prevention of cystine stone formation | May 2021 |
| pregabalin | Lyrica CR® | Pfizer | Neurological pain | April 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
GENERICS OF TOP SELLING BRAND DRUGS POTENTIALLY AVAILABLE SOON
| Generic Name | Brand Name | Brand Manufacturer | Indication(s) | To Market Date* |
| goserelin acetate+ | Zoladex® | AstraZeneca | Prostate cancer | 04/13/2022 |
| dabigatran etexilate mesylate | Pradaxa® (capsules) | BI | Atrial fibrillation | 2Q 2022 |
| oxycodone hydrochloride | Oxaydo® | Egalet | Pain | 1H 2022 |
| ethinyl estradiol; levonorgestrel | Balcoltra® | Avion Pharmaceuticals | Contraception | 2022 |
| formoterol fumarate; mometasone furoate | Dulera® | Merck | Asthma | 2022 |
| enalapril maleate | Epaned® KIT | Silvergate | Heart failure | 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 | Acne vulgaris | 2022 |
| lenalidomide+ | Revlimid® (2.5, 20mg) | Celgene/ BMS | Non-Hodgkin’s lymphoma | 2022 |
| octreotide acetate+ | Sandostatin® LAR | Novartis | Endocrine gland disease | 2022 |
| thalidomide+ | Thalomid® | Celgene/ BMS | Leprosy | 2022 |
| fesoterodine fumarate | Toviaz® | Pfizer | Overactive bladder | 2022 |
| tafluprost | Zioptan® | Akorn | Glaucoma | 2022 |
* Expected to market dates are predictions made by Prime Therapeutics based on industry information.
+Specialty medication
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