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If you’ve lived in your home for two years, you can take a tax-free gain of $250K for a

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

single filer and $500K for married (filing jointly). You just have to have used the prop

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

Examples of combination products may in

erty as your principal residence for two of the past five years. You can even rent your

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

house out for most of that period and still qualify for the full gain!

If you’ve lived

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

in your home for less than two years, you can still take a “reduced exclusion amount” (p

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

Combination pro

ro-rated from the full amount according to how long you’ve lived there) if you’re “force

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

d” to move because of “unforeseen circumstances” – which can simply mean that you’ve sta

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

rted (or ended) a home-based business. If you’ve lived in your home more than two year

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

s, you can always re-finance it to remove the value. If the current market interest rate

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

s are higher than your existing loan, for instance, get a home equity loan instead. Once

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

your gain approaches $250K if you’re single (or $500K if married), it’s time to move.

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

Following aspects would a

If you decide to rent out a room in your house, you’ve created a home business from whic

dd to the challenges in developing combination products:

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

h you can deduct relevant expenses against the rental income, as well as the depreciatio

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

n of the space. And when you sell the house, you can exclude the gain on the pro-rated p

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

ortion.

If your income grows so high that you begin to lose itemized deductions, you ca

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

n always move the mortgage interest deduction off Schedule A by using the home office de

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

Professional from academic institutions, pharmaceutical industries, health care indust

duction, which allows you to deduct a pro-rated portion of the mortgage interest and pro

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

perty tax on a separate schedule.

If you wish to take out a home equity loan that’s ful

.

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

ly deductible, simply demonstrate that the additional debt above the amount allowable wa

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

Companies that provide selfless information through particip

s used for business or investment purposes – such as buying in to an apartment building.

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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