Perspectives
Traditional Drug Pipeline Quarterly Update: September 2022
Critical updates in an ever changing environment
September 30, 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
- Daxxify® (daxibotulinumtoxinA-lanm): The U.S. Food and Drug Administration (FDA) has approved Revance’s Daxxify for injection for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults. Approval of Daxxify was based on the Phase 3 clinical trial, SAKURA, which demonstrated 74% of subjects achieved a > two-grade improvement in glabellar lines at week four per both investigator and patient assessment, and 88% achieved > two-grade improvement at week four per investigator assessment.1 Daxxify had a median duration of six months. Launch and pricing of Daxxify are pending.
- Aponvie® (aprepitant): The FDA has approved Heron Therapeutics’ Aponvie injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults. Aponvie is a neurokinin-1 (NK1) receptor antagonist that was approved via the 505(b)2 pathway using Merck Sharp & Dohme Corp’s Emend®as its reference drug. Delivered via a single 30-second IV injection, Aponvie has demonstrated rapid achievement of therapeutic drug levels ideally suited for the surgical setting.2 Aponvie launch and price are pending.
Generic Drug Information
- Vascepa® 0.5gm (icosapent ethyl): Teva launched their generic version of Amarin’s Vascepa® 0.5gm (icosapent ethyl), as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia or as an adjunctive therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 mg/dL or higher. In 2020, multiple manufactures launched their generic version of Vascepa 1gm. Both strengths of Vascepa combined generated $1331 million in U.S. annual sales in 2021.
- Revlimid® 2.5, 20mg capsules (lenalidomide cap, 2.5mg, 20mg) : Dr. Reddy’s has launched their generic version of Bristol-Myers Squibb’s Revlimid 2.5, 20mg. 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 and mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Dr. Reddy’s is eligible for 180-day exclusivity for these strengths. Multiple manufacturers are scheduled to launch in 2023. Revlimid 2.5mg and 20mg capsules generated $815 million in U.S. annual sales in 2021.
- Suprep® (sodium sulfate/potassium sulfate/magnesium sulfate oral soln, 17.5-3.13-1.6 gm/177 mL): Lupin Pharmaceuticals launched their generic version of Braintree Lab’s Suprep, an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. Suprep generated $292 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*
|
|
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 | |
maribavir | Livtencity™ | Takeda | Cytomegalovirus (CMV) infection | November 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* | |
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 | |
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 |
* 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 | |
reltecimod | N/A | Atox Bio | Necrotizing soft tissue infection | 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 | |
linzagolix | N/A | ObsEva | Uterine fibroids | September 2022 | |
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 | |
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 |
FIRST GENERIC LAUNCHES OF TOP SELLING BRAND NAME DRUGS IN THE PAST TWELVE MONTHS
Generic Name | Brand Name | Brand Manufacturer | Indication(s) | Approval Date* | |
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,
4 mg, 8 mg |
Toviaz® | Pfizer U.S. | Overactive bladder | July 2022 | |
vilazodone tab,
10 mg, 20 mg, 40 mg |
Viibryd® | Allergan | Major depressive disorder | June 2022 | |
pemetrexed inj,+
100 mg, 500 mg |
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,
267 mg, 801 mg |
Esbriet® | Genentech | Idiopathic pulmonary fibrosis (IPF) | May 2022 | |
bortezomib inj,
3.5 mg+ |
Velcade® | Takeda Pharmaceuticals | Multiple myeloma, mantle cell lymphoma | May 2022 | |
lacosamide tab,
50 mg, 100 mg, 150 mg, 200 mg |
Vimpat® tab,
50 mg, 100 mg, 150 mg, 200 mg |
UCB Pharma | Partial-onset seizures; primary generalized tonic-clonic seizures | March 2022 | |
lenalidomide+ | Revlimid® (5, 10, 15, 25 mg) | 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, 5 mg/spray | Zomig® nasal spray | AstraZeneca | Migraine headache | November 2021 | |
everolimus+ | Afinitor® (10 mg) | Novartis | Kidney cancer | October 2021 | |
everolimus+ | Afinitor® Disperz | Novartis | Certain forms of cancer | October 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* | |
timolol (pf) ophth soln, 0.25% | Timoptic® Ocudose, 0.25% | Bausch Health | Glaucoma/ocular hypertension | September 2022 | |
atropine sulfate IV soln,
0.4 mg/mL, 1 mg/mL |
Atropine Sulfate® | Accord Healthcare | Temporary blockade of severe or life threatening muscarinic effects | August 2022 | |
iodixanol inj,
270 mg/mL |
Visipaque® | GE Healthcare | Intra-arterial procedures, Intravenous procedures | July 2022 | |
methylphenidate TD patch, 10mg/9 hour, 15mg/9 hour, 20mg/9 hour, 30mg/9 hour | 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® 500 mg | Shire | Ulcerative colitis/
Crohn’s Disease |
May 2022 | |
lacosamide oral soln,
10mg/mL |
Vimpat® oral soln, 10 mg/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,
4 mg/mL |
Prexxartan® (discontinued) | Medicure | Hypertension | April 2022 | |
isosorbide dinitrate-hydralazine tab, 20-37.5 mg | 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®,
25 mg |
Assertio Therapeutics | Relief of mild to moderate acute pain | March 2022 | |
tolvaptan tab, 15mg | Samsca tab® (15 mg) | 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 | |
*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* | |
rufinamide | Banzel® (100mg tablets) | Eisai | Epilepsy | 2H2022 | |
sodium oxybate+ | Xyrem® | Jazz Pharmaceuticals | Sleep | 2H 2022 | |
gefitinib+ | Iressa | AstraZeneca | Lung cancer | 3Q2022 | |
oxycodone hydrochloride | Oxaydo® | Egalet | Pain | 2022 | |
enalapril maleate | Epaned KIT® | Silvergate | Hypertension | 2022 | |
fluticasone propionate | Flovent HFA® | GSK | Asthma | 2022 | |
rotigotine | Neupro® | UCB | Parkinson’s disease | 2022 | |
ritonavir | Norvir® (capsules) | AbbVie | HIV | 2022 | |
benzoyl peroxide; clindamycin phosphate | Onexton® | Dow Pharmaceutical Sciences | Acne | 2022 | |
octreotide acetate+ | Sandostatin® LAR | Novartis | Endocrine gland diseases | 2022 | |
thalidomide | Thalomid® | Celgene | Leprosy | 2022 | |
tafluprost | Zioptan® | Akorn | Glaucoma or ocular hypertension | 2022 | |
ethinyl estradiol; levonorgestrel | Balcoltra® | Avion Pharmaceuticals | Pregnancy prevention | 2022-2024 |
* Expected to market dates are predictions made by Prime Therapeutics based on industry information.
+Specialty medication
REFERENCES
- https://investors.revance.com/news-releases/news-release-details/revance-announces-fda-approval-daxxifytm-daxibotulinumtoxina
- https://www.prnewswire.com/news-releases/heron-therapeutics-announces-us-fda-approval-of-aponvie-htx-019-for-the-prevention-of-postoperative-nausea-and-vomiting-ponv-301626450.html
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