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ACTIVE PHARMA INGREDIENTS

11 API Suppliers, 1 JDMF, 1 NDC API, 9 Listed Suppliers, $ API Reference Price

11 API Suppliers
1 JDMF
1 NDC API
9 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

100 Drugs in Development

100 Drugs in Development

FINISHED DOSAGE FORMULATIONS

145 FDF Dossiers, 11 FDA Orange Book, 8 Europe, 15 Canada, 102 Australia, 6 South Africa, 3 Listed Dossiers

145 FDF Dossiers
11 FDA Orange Book
8 Europe
15 Canada
102 Australia
6 South Africa
3 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 BASF, 1 Gangwal Chemicals, 2 Seppic

relatedExcipients
1 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 BASF
1 Gangwal Chemicals
2 Seppic

EXCIPIENTS BY APPLICATIONS

4 Solubilizers, 3 Parenteral, 2 Topical, 2 Surfactant & Foaming Agents, 1 Taste Masking, 1 Emulsifying Agents, 1 Thickeners and Stabilizers

excipientsByApplications
4 Solubilizers
3 Parenteral
2 Topical
2 Surfactant & Foaming Agents
1 Taste Masking
1 Emulsifying Agents
1 Thickeners and Stabilizers

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 316 News #PharmaBuzz

media
2 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
316 News #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 5 Regulatory FDF Prices, 25 Annual Reports

globalSalesInformation
8 US Medicaid Prescriptions
5 Regulatory FDF Prices
25 Annual Reports

MARKET PLACE

4 APIs, 10 FDF Dossiers

marketPlace
4 APIs
10 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

patents
8 Health Canada Patents

LGM Trastuzumab

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

FINISHED DOSAGE FORMULATIONS

145

FDF Dossiers

FDA Orange Book

Europe

Canada

102

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

14EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

API REF. PRICE (USD/KG)

GLOBAL SALES INFORMATION

US Medicaid (USD)

27,006,261

Annual Reports (USD Million)

51,759

Regulatory FDF Prices

API/FDF Prices: Book a Demo to
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MARKET PLACE

API

FDF

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

316

News #PharmaBuzz

Chemistry

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API SUPPLIERS

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JDMF

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NDC API

01

Patheon Manufacturing Services LLC

U.S.A

APGA Annual Conference

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Listed Suppliers

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Drugs in Development

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FDF Dossiers

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FDA Orange Book

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Europe

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Canada

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Australia

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South Africa

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Related Excipient Companies

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Excipients by Applications

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Solubilizers

Parenteral

Topical

Surfactant & Foaming Agents

Taste Masking

Emulsifying Agents

Thickeners and Stabilizers

Digital Content

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DATA COMPILATION #PharmaFlow

FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding.