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What do most companies do when one of their major brands is hit by a price at

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

tack?

The classic response is “wait and see.” Wait and see if it affects our

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

Examples of combination products may in

sales. Wait and see if the competitor can hang in there financially for the

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

ong haul. Wait and see if our customers come back after trying the low-priced

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

alternative.

What would your company do if a major competitor suddenly cut

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

Combination pro

its price substantially? Be prepared. The leader should be emotionally ready

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

o strike back.

What would you do? Are you sure?

As the battle for Migraine

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

Mountain proved, there would have been plenty of business for both Johnson &

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

Johnson’s high-priced Tylenol and Bristol-Myer’s low-priced Datril. But it wo

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

ld not have been good strategy for Johnson & Johnson to share the market.

A

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

live-and-let-live philosophy has no place in warfare. Companies like Johnson

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

Following aspects would a

& Johnson and Procter & Gamble take no prisoners. Competition is always in y

dd to the challenges in developing combination products:

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

ur face. You are Defending too much. But that could be counter productive. Be

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

prepare to attack also. Competition is always in your face. You are Defendi

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

ng too much.

But that could be counter productive. Be prepare to attack also

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

As the battle for Migraine Mountain proved, there would have been plenty of

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

Professional from academic institutions, pharmaceutical industries, health care indust

business for both Johnson & Johnson’s high-priced Tylenol and Bristol-Myer’s

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

low-priced Datril. But it would not have been good strategy for Johnson & Jo

.

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

nson to share the market.

A live-and-let-live philosophy has no place in war

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

Companies that provide selfless information through particip

fare. Companies like Johnson & Johnson and Procter & Gamble take no prisoners

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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