L2-The modern pharma landscape:branded blockbusters to generics

What is a drug

An active pharmaceutical ingredient which is responsiblefor its biological effect

What is medicine?

The final formulated product designed for patient use which contain the API and excipients which depend on the dosage form and needed drug release.

What are some of the things driving the pharmaceutical market?

Aging populations - disease burden - research and development investment

How do pharmaceutical companies stay successful

Firstly, ensure that new medicines are frequently brought to market

What is the pipline of new chemical entires?

Identifying disease targets, developing candidate drugs,formulating them into suitable medicines for registration and sale.

Describe now medicinal products are named.

Brand names, common name, systematic name

Explain how the brand name is made.

It's developed by the company with the help of branding agencies.it must be approved by regulatory authorities.

Explain how the common name of a medicine is decided.

It's decided by the WHO- the non-proprietary names follow a specific system (prefix's infixes stem and suffix.)

What is a blockbuster medicine.?

A medicine with sales over $1 million per annum, now make up 40% of the pharmaceutical market

They take a long time (10-15 years) to market and require high investment

explain why branding is important for pharmaceutical companies

strong branding sets their medicines apart and builds consumer trust and confidence

explain the use/ importance of a trademark

its a symbol that distinguishes the source of goods or services

they protect brand identity and prevent consumer confusion

what is a patent

intellectual property that gives the inventor a legal right to exclude others from making using, selling and importing an invention for a limited time usually 20 years

the invention must be novel, non-obvious and must have practical use

explain how and why medicines are protected by patent

a patent is filed when the invention is disclosed publicly and protects the medicine from the day its first filed for 20 years but medicine development takes 10-15 years

companies file for them to maximise the period of exclusivity for their branded medicines and preventing from generic competition for as long as possible

some companies even use evergreening and thickets ( applying new patents for minor modification and delivery methods )

what is a patent cliff

it refers to a sharp drop in sales and profits that a company experiences when the patent on one of its drugs expires

the end of this exclusivity opens doors for generic manufacturers

puts blockbuster drugs at risk

what is a generic medication

medication with the same active substance, same strength and dosage form as the branded product but instead of the brand name the common name is used

the profits for generics are lower but they can become blockbusters

what is the significance of generic medicines

they go through the same quality standards as branded drugs

they can be bioequivalent or biosimilar

dues to the strong branding and marketing of some generic medicines they are very widely recognised by consumers

also they are more cheaper so more accessible for consumers