Next Decade Generic String Of Pearls Opportunities: Sustainability Assessment With Respect To Therapeutic Positioning

  • ID: 4430913
  • Report
  • Region: Global
  • 127 Pages
  • MP Advisors
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FEATURED COMPANIES

  • Abbvie
  • Astra Zeneca
  • Gilead Sciences
  • Johnson & Johnson
  • Novartis
  • Teva
  • MORE

The rapid growth of the generic industry has come with a number of challenges, such as heavy competition, including from authorized generics and government-mandated price cuts. All contribute to diminishing prices and ever decreasing margins. In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Diversification of product portfolios, vertical integration across the manufacturing process, and expanding their geographic presence, especially into emerging markets are some of the key strategies which can be implemented by the generic companies to overcome the existing challenges.

One of the most initial and important step for the development of a prospective generic drug product comprises of product (Active Pharmaceutical Ingredient-API) selection and identification. API is the primary constituent of a pharmaceutical drug product that governs the final cost of the drug product as well as the commercial profit earned by the company. Early access to high-quality active pharmaceutical ingredients (API) that are not infringing patents is critical to success in regulated finished-dose markets as a significant part of generics’ profits is made during the early days of their availability.

Factors which have to be taken into consideration during the generic product evaluation process include:

  • The total geographical and target disease market size.
  • Therapeutic areas of the product-whether the drug in question is approved for a niche condition or is trying to make a space for itself in the already crowded therapy class.
  • Competitor intelligence.
  • Current market sales of the innovator product.
  • Patent/exclusivity time frame.
  • Complexity in the development and time frames.
  • Availability of API, equipment and expertise.
  • Budget required and return on investment.

Keeping in mind the above mentioned elements we have scrutinized and selected 10 drug molecules. This information in the report can aid a prospective generic developer to review and evaluate products which can be incorporated in the company’s developmental pipeline.

The therapy classes covered in this report are:

  • Oncology
  • Cardiovascular
  • Respiratory
  • Gastroenterology
  • Psychiatry
  • Infectious disease

The following points were considered while selecting the products:

  • Blockbuster drugs with a likelihood of lucrative future sales.
  • Drugs with novel therapeutic approach for rare disease.
  • Specialized products in niche therapeutic markets with no existing competitors.
  • Products with robust ongoing clinical trials which will lead to future label expansions and ultimately act as sales booster.
  • First in class drug products with novel targeting mechanism.
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Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Abbvie
  • Astra Zeneca
  • Gilead Sciences
  • Johnson & Johnson
  • Novartis
  • Teva
  • MORE

Executive Summary   

Factors to Be Considered During the Product Evaluation Process   

Stages in the Development of a Generic Drug Product   

Potential Challenges in the Various Development Stages   

Opportunity Areas for Generic Product Development   

Jakafi   

Mechanism of Action   

Jakafi in Myelofibrosis (Mf)   

Jakafi in Polycythemia Vera (Pcv)   

Jakafi in Graft-Versus-Host Disease (Gvhd)   

Clinical Study Data   
The Comfort-I And -Ii Study   
Comfort-I
The Primary End Point  
Secondary End Points 
Comfort -Ii
Response Trial   
The Primary End Point   
The Secondary End Points 

Ongoing Research Program 

Orkambi   

Clinical Study Data   
Traffic And Transport   
Progress Study   

Label Expansion to Treat 6- to 11-Year-Old:   

Market Performance And Competition:   

Imbruvica   

An Overview of the Fda Approval History of Imbruvica   

Imbruvica in Chronic Lymphocytic Leukemia (Cll)   

Imbruvica in Waldenström's Macroglobulinemia(Wm)   

Imbruvica in Mantle Cell Lymphoma (Mcl)   

Imbruvica in Marginal Zone Lymphoma (Mzl):   

Imbruvica in Chronic Graft Versus Host Disease (Cgvhd)   

Clinical Study Data   
Mantle-Cell Lymphoma   
The Pcyc-1104   
Chronic Lymphocytic Leukemia (Cll)  
Resonate Trial: Ibrutinib Versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia   
Long-Term Follow-Up Results from the Pivotal Phase 3 Resonate Trial  
Resonate-2: Ibrutinib As Initial Therapy for Patients With Chronic Lymphocytic Leukemia   
Updated Results from the Pivotal Phase 3 Resonate-2 Trial  
Imbruvica in Waldenstrom's Macroglobulinemia
Imbruvica for Relapsed/Refractory Marginal Zone Lymphoma (Mzl)  
Imbruvica (Ibrutinib) for Chronic Graft Versus Host Disease   

Imbruvica- On the Verge of Becoming a Mega-Blockbuster Drug   

Market Performance And Competition:   

Entresto   

Clinical Study Data   
Paradigm-Hf   

Market Performance And Competition   

Ibrance   

Clinical Study Data   
Paloma-1  
Paloma-2  
Paloma-3  

Ongoing Research   
1. the Patina Trial  
2. the Pallas Trial   
3. Nct02499120 

Epclusa   

Clinical Study Data   
Astral-1   
Astral-2 And Astral-3 
Astral-4   
Astral-5   

Market Performance And Competitors   

Lynparza   

Harnessing the Potential of Parp Inhibitors in Ovarian Cancer   

Clinical Study Data   
Solo-2:   
Study 19   

Market Performance And Competition:   

Ongoing Research   
Lynparza: Paving Its Way Towards Brca-Mutated Breast Cancer- the Olympiad Trial   
Paola Trial   
Polo Trial   
Profound Trial   
Concerto Trial   

Uptravi   

Clinical Study Data   
Griphon Trial  

Market Performance And Competitors   

Ongoing Research   

Triton Trial  

Transit Trial  

Ingrezza   

Clinical Study Data  
Kinect 3-   
Extension Study of Ingrezza 40 Mg And Ingrezza 80 Mg (Intent-To-Treat-Itt Population)  

Market Performance And Competition   
T-Forward Study   
T-Force Green Study   
T-Force Gold Study   

Ocaliva   

Clinical Study Data   
The Poise Trial-   
Open-Label Extension   

Market Performance And Competition   
FDA Concern Regarding Incorrect Dosing of Ocaliva   

Ongoing Research:   
Cobalt Trial-   
Regenerate Trial- Effect of Obeticholic Acid Treatment On Nonalcoholic Steatohepatitis (Nash)   
Flint Trial   

List of Figures
Figure 1 The Therapy Classes Covered in this Report   
Figure 2 Stages in the Development of a Generic Drug Product   
Figure 3 Potential Challenges in the Various Development Stages   
Figure 4 Jakafi Key Points   
Figure 5 Comfort I Primary End Point   
Figure 6 Comfort I Secondary End Point   
Figure 7 Comfort Ii Primary End Point   
Figure 8 Response Primary End Point   
Figure 9 Orkambi Key Points   
Figure 10 Efficacy Results from Traffic And Transport   
Figure 11 Imbruvica Key Points   
Figure 12 An Overview of the Fda Approval History of Imbruvica   
Figure 13 The Pcyc-1104 Results   
Figure 14 Resonate Trial-Progression-Free And Overall Survival   
Figure 15: Progression-Free Survival With Ibrutinib Versus Chlorambucil.   
Figure 16 Overall Survival And Response Rates With Ibrutinib Versus Chlorambucil.   
Figure 17 Entresto Key Points   
Figure 18 Paradigm-Hf: Clinical Endpoints   
Figure 19 Ibrance Key Points   
Figure 20 Epclusa Key Points   
Figure 21 Lynparza Key Points   
Figure 22 Solo-2 Trials Results   
Figure 23 Study 19 Results   
Figure 24 Uptravi Key Points   
Figure 25 Primary Endpoint:Time to First Disease Progression Event in the Griphon Trial   
Figure 26 Griphon Trial Primary Endpoint Events Up to the End of Treatment   
Figure 27 Ingrezza Key Points   
Figure 28 Kinect-3 Results   
Figure 29 Results of Extension Study of Ingrezza   
Figure 30 Ocaliva Key Points   
Figure 31 Primary Composite End Point in the Double-Blind And Open-Label Extension Phases   
Figure 32 Alkaline Phosphatase And Total Bilirubin Levels in the Double-Blind And Open-Label Extension Phases   

List of Tables
Table 1 List of Selected Molecules   
Table 2 Jakafi Patent Details   
Table 3 Orkambi Patent Details   
Table 4 Imbruvica Patent Details      
Table 5 Entresto Patent Details   
Table 6 Major Trials in the Fortihfy Program   
Table 7 Ibrance Patent Details    
Table 8 Results of Paloma-2 Trial   
Table 9 Results of Paloma-3 Trial   
Table 10 Epclusa Patent Details   
Table 11 Astral Trials- Study Outcome   
Table 12 Lynparza Patent Details   
Table 13 Uptravi Patent Details   
Table 14 Ingrezza Patent Details    
Table 15 Ocaliva Patent Details   
Table 16-Competitive Landscape for the Selected Molecules   

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  • Abbvie
  • Actelion
  • Astra Zeneca
  • Eli Lilly
  • Gilead Sciences
  • Intercept
  • Johnson & Johnson
  • Neurocrine
  • Novartis
  • Pfizer
  • Teva
  • Vertex Pharmaceuticals
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