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BASICS IN PHARMA.

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Presentation on theme: "BASICS IN PHARMA."— Presentation transcript:

1 BASICS IN PHARMA

2 Definition of 'Market Share'
The percentage of an industry or market's total sales that is earned by a particular company over a specified time period. Market share is calculated by taking the company's sales over the period and dividing it by the total sales of the industry over the same period. This metric is used to give a general idea of the size of a company to its market and its competitors.

3 Competitive Market A market with a large number of buyers and sellers, such that no single buyer or seller is able to influence the price or control any other aspect of the market. That is, none of the participants have significant market control. A competitive market achieves efficiency in the allocation.  Efficiency is achieved because competition among buyers forces buyers to pay their maximum demand price and competition among sellers forces sellers to charge their minimum supply price for the given quantity exchanged. of scarce resources if no other market failures are present.

4 Branded and Generic Drugs
Branded Product - Pfizer Generic Product - Watson

5 A generic drug is the bio-equivalent version of a brand name drug.
What are Generic Drugs A generic drug is the bio-equivalent version of a brand name drug.  Bio-equivalence, certified by the U.S. FDA, means a generic drug has the same dosage form, safety, strength, route of administration, quality, performance characteristics and intended use as the branded version of the drug. Although therapeutically equivalent to their branded counterparts, generic drugs are typically sold at substantial discounts from the branded price.

6 Why is there a difference in cost between branded drugs and generic drugs ?
New drugs, like other new products, are typically developed with patent protection. The patent protects the investment a company makes in investing in the drug's development by giving the company the right to exclude others from selling the drug while the patent is in effect. When patents expire, other manufacturers can make and sell the FDA approved generic versions of the drug. The ANDA process does not require the drug sponsor to repeat the costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. Since generic manufacturers have plenty of competition, lower R&D costs, and spend much less on advertising and marketing efforts, their products are priced much lower than branded counterparts. An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.

7 Are generic drugs as safe and effective as branded drugs?
The U.S. FDA regulates all generic products under strict guidelines, requiring the same testing as the branded product to ensure that the generic version is interchangeable with its branded counterpart. For both brand name and generic drugs, the U.S. FDA works with pharmaceutical companies to ensure that all drugs marketed in the U.S. meet specifications for identity, strength, quality, purity and potency. In approving a generic drug, the U.S. FDA has tests and procedures to ensure that the generic drug is interchangeable with the brand name drug under all indications and conditions of use for which the branded product is approved.

8 Do generics differ at all from brands?
Generics may differ slightly from brands in regards to inactive ingredients.  The U.S. FDA allows generics to use different inactive ingredients, from those used in the brand, as long as bioequivalence is attained.  Inactive ingredients, such as fillers and dyes, do not affect the safety or performance of drugs or API.

9 Major therapies and molecules

10 Major Molecules and Diseases
Sr.No. CAUSE OF DEATH MALE FEMALE TOTAL (Ages as percentages) 1 Cardiovascular Disease 26.3 22.5 24.8 2 Respiratory Disease 10.1 10.4 10.2 3 Tuberculosis 11.4 8.3 4 Malignant and other tumours 7.8 11.8 9.4 5 ILL defined conditions 4.8 6.0 5.3 6 Digestive Systems 6.1 3.5 5.1 7 Diarrhoeal Diseases 4.0 6.6 5.0 8 Malaria 2.4 3.4 2.8 (All ages expressed as percentages)

11 Major Molecules and Diseases
Sr.No. CAUSE OF DEATH MALE FEMALE TOTAL (All ages expressed as percentages) 1 Cardiovascular Disease 20.3 16.9 18.8 2 Respiratory Disease 9.3 8.0 8.7 3 Diarrhoeal Diseases 6.7 9.9 4 Prenatal Conditions 6.4 6.2 6.3 5 Respiratory Conditions 5.4 7.1 6 Tuberculosis 4.7 6.0 7 Malignant and other tumours 5.0 5.7

12 Indian pharmaceutical market ( IPM) therapies by market share

13

14 THANK YOU -PHARMA STREET


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