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Patents grant exclusive rights to the inventor for a fixed period. The inventor has effective market monopoly o

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

r exclusivity on the product for the period. This enables the pharmaceutical companies to charge high prices fo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

their patented product based on what the individual market can bear without fear of competition. R&D is severe

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

y crippled by the fear of encroaching on the patent rights during research so competition is almost non-- exist

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

nt during the life of the patent.

It seems that this huge commercial advantage is the real reason behind the p

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

armaceutical companies’ insistence on patent protection. This is only natural as R&D is a very costly and risky

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

but there is also need to maintain a balance between commercial interests of the companies and public needs. Th

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

pharmaceutical market in African countries is almost negligible compared to global market so these companies c

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

n still make their profits from sale in the rest of the world where people can afford these drugs. In any case,

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

since the continuous production of a drug after the initial development costs close to nothing and pharmaceutic

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

l companies usually expect to recoup the original cost of development from the first generation of patents, by

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

harging less, the companies could still recover development costs and make profit because more people will be a

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

le to afford the drugs.

Patents also affect availability of the drugs. There are many pharmaceutical countries

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

in developing countries but with the rapid increase in the amount of infected people everyday, they will not be

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

able to provide enough drugs for all the people that need them even if they could all afford them. It is very i

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

portant that infected people have a constant supply of the drugs to prevent resistant strains from developing.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

hough member countries may improve their access by making use of the new developments in patent laws discussed

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

elow, it will not contribute to overall availability of the drugs because under the provisions, only the amount

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

needed by the eligible importing country can be manufactured and for the sole purpose of exporting to them to u

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e domestically. A slight increase in the number of people that need treatment would therefore create a shortage

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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