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Hopefully you realize that before you do much of anything, you need to look at the marke

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

tability of your invention.

Remember, you don’t want to do anything until you have a go

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

Examples of combination products may in

od feel for whether or not you can actually make some money from your invention. Of cou

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

rse, you can’t ever determine with 100% accuracy if you will make money or how much, but

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

you can gain an idea by looking at other products available in the marketplace.

So you

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

Combination pro

need to become an expert at products in the marketplace similar to your invention!

Onc

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

e that’s done, what’s the next step?

Well wouldn’t you know it, it’s actually a little

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

ore of the same! That’s right; you need to become even more of an expert at product’s s

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

imilar to your invention. This time, in the form of a preliminary patent search.

You c

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

an’t patent it if it’s not new. Remember that phrase. It absolutely, positively, must

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

be a novel invention. Now yours can be similar to something else, but it should have a

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

Following aspects would a

feature or even better yet, features that make it stand apart. The novel feature(s) is

dd to the challenges in developing combination products:

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

what you eventually will seek to gain a patent on.

So in addition to searching through

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

what is already sold and marketed, you need to determine if your invention has ever been

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

written about. Whether in a publication, a patent or even in a thesis shelved away in t

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

he library, you need to make sure your invention is novel.

Of course, a patent search w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ill be performed by an examiner when your patent application is received by the USPTO.

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

But since filing a patent requires quite a bit of time and a decent amount of money, you

.

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

should do your own preliminary patent search first. Make sure your idea really is new.

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

Companies that provide selfless information through particip

Wouldn’t it be nice to know if all this initial trouble was going to get you somewhere

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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