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An S corporation is a type of corporation that the IRS recognizes. S corporations fo

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

llow taxation rules that differ from those that regular corporations follow. A main

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

Examples of combination products may in

difference is that S corporations are exempt from double taxation. This is because t

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

e owner declares the income a corporation receives in individual tax returns. Corpor

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

ations are not subjected to taxation of the income. The taxation rules follow those

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

Combination pro

of sole proprietorship and partnership businesses. However, they enjoy the limited l

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

iability (protection) corporations receive.

To apply for an S corporation status, y

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

ou need to incorporate your business. To do this, you need to file formal paperwork

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

alled the “articles of incorporation” and pay the appropriate fees. Once you have do

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

ne the necessary steps to incorporate, you will be able to apply for an S corporatio

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

tax status. You do so with the IRS by filling out the necessary forms in your state

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

Following aspects would a

, as well as federal.

If you choose to obtain an S corporation status, every shareh

dd to the challenges in developing combination products:

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

older in your corporation must apply within 90 days from the beginning of the fiscal

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

year. Once you have been approved as an S corporation, you may keep that status for

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

as long as you wish. To revoke your S corporation status, you need to send a lette

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

of revocation to the state revenue department and the federal IRS. All shareholders

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

Professional from academic institutions, pharmaceutical industries, health care indust

must sign the letter.

Every state has different rules and regulations pertaining t

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

o an S corporation status. You will need to fill out different forms for different

.

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

tates. The one requirement that is consistent to every state is that you first need

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

Companies that provide selfless information through particip

to register with the IRS to become eligible for an S corporation status in any state

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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