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Your estate consists of the assets that you will pass on to your beneficiaries when you pass away. Estate planning means deciding where your assets will go when you die. It takes tim

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

e, thought, and the knowledgeable assistance of a qualified attorney.

Even if you diligently plan your estate on your own, it is easy to make mistakes. Mistakes can result in portio

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

Examples of combination products may in

s of your estate being unnecessarily taxed and assets going to the wrong beneficiaries.

We have compiled a list of some of the most common mistakes individuals make in estate planni

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

ng. Please review the list, but also plan to meet with a qualified attorney to review your unique estate.

Failure to Prepare
One of the most common mistakes people make

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

hen it comes to their estate is that they simply fail to prepare a plan. Many people, especially the young and healthy, never even set up a Living Will. Living Wills are important to

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

Combination pro

have at any age because they serve as a directive in the event that you become incapacitated. Even though far fewer young people plan their estates, more than twice as many 20-someth

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

ings die in car accidents than 60-somethings. Therefore, it is crucial that you plan your estate regardless of your age, health, or income level.

Choose your Beneficiaries

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

Your beneficiaries are those individuals who will inherit your estate when you die. It is important that you carefully consider and name your beneficiaries. Choose the appropriate

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

ndividuals for the estate you will be leaving behind.

Many times, beneficiaries are children and spouses. However, if you have young children, you may not feel comfortable setting u

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

p your estate so that they inherit a large sum of money directly. How will they spend it? Are you sure that they would make wise choices?

If you would like to have more control over

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

the estate after you die, then it is important that you set up a Trust for your beneficiaries. By establishing a Trust, you can allocate a certain portion of your estate towards a ch

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

Following aspects would a

ld’s education, first home, or other purpose of your choosing. Consult with a qualified attorney for more information about how to set up your estate for your beneficiaries.

Choo

dd to the challenges in developing combination products:

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

se your Agent
Central to estate planning is choosing people to make decisions for you both during incapacity and after your death. These people include trustees, guardians,

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

gents, and beneficiaries. Make sure that you select an agent who knows you and your wishes well. He or she will speak for you when you cannot, so it is vitally important that he or s

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

e knows you well. Make sure you and the agent have a clear understanding of his or her role in your estate and that you have clearly communicated your desires.

Leaving Assets

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

A significant portion of your assets might be vulnerable to estate taxes after you die. However, there are ways to leave behind an estate without losing most of it to taxes. It

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

Professional from academic institutions, pharmaceutical industries, health care indust

is important that you consult with a qualified attorney to discuss the most strategic methods for establishing your unique plan. A well-crafted plan will ensure that your beneficiari

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

s get the most benefit from your years of hard work.

Review your Estate
Because life events, such as divorce, loss of job, etc., may change your assets, it is important

.

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

to periodically revisit your plan to ensure that it is always current. Many people die without reviewing their assets, so their plans cannot be carried out as they had desired. By re

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

Companies that provide selfless information through particip

ularly reviewing your plan, you are able to help your beneficiaries inherit the assets you leave behind for them without having to fight for them in court or with other beneficiaries

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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