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Bankruptcy is a legally declared inability or impairment of ability of an individual or organization to pay their creditors. A declared state of bankruptcy can be requested by creditors in

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

an effort to recoup a portion of what they are owed; however, in the majority of cases, bankruptcy is initiated by the bankrupt individual or organization.

The purposes of bankruptcy are

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

Examples of combination products may in

(1) to give an honest debtor a "fresh start" in life by relieving the debtor of most debts, and (2) to repay creditors in an orderly manner to the extent that the debtor has the means ava

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

ilable for payment.

The word bankruptcy comes from the ancient Latin bancus (a bench or table), and ruptus (broken). Bank originally signified a bench, which the first bankers had in publ

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

c places, markets, fairs, etc. on which they tolled their money, and wrote their bills of exchange. Therefore, when a banker failed, he broke his bank, to advertise to the public that the

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

Combination pro

erson to whom the bank belonged was no longer in a condition to continue his business.

Bankruptcy in the United States is placed under Federal jurisdiction by the United States constituti

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

on, which allows Congress to enact “uniform laws on the subject of Bankruptcy throughout the United States.” Its implementation, however, is found in statute law. The relevant statutes are

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

incorporated within the Bankruptcy Code, located at Title 11 of the United States Code.

There are six types of bankruptcy under the Bankruptcy Code, located at Title 11 of the United Stat

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

es Code:

· Chapter 7 (a liquidation-style case for individuals or businesses).

· Chapter 9 (Municipal bankruptcy).

· Chapter 11 (a more complex rehabilitation-style case used primarily

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

y business debtors, but sometimes by individuals with substantial debts and assets).

· Chapter 12 (a payment plan or rehabilitation-style case for family farmers and fishermen).

· Chapte

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

13 (a payment plan or rehabilitation-style case for individuals with a regular source of income).

· Chapter 15 (ancillary and other cross-border cases).

The most common types of persona

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

Following aspects would a

l bankruptcy for individuals are Chapter 7 and Chapter 13.

Chapter 7 personal bankruptcy is also known as straight bankruptcy, or liquidation bankruptcy. Under Chapter 7, debtors give up

dd to the challenges in developing combination products:

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

ertain property that they own when they go bankrupt. The property is sold, and the proceeds are used to pay the creditors. In most cases debtors do not have any assets, and thus in most ca

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

ses they do not lose anything. In most Chapter 7 cases most debts are discharged about 90 days after filing. Debts that are discharged (which means they go away) include credit card debts.

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

Debts that are not discharged would include child support payments and some taxes and student loans. Secured debts, such as car loans and house mortgages, are also not discharged.

Under 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

e new rules implemented as a result of the 2005 Bankruptcy Reform, it is now more difficult to qualify for Chapter 7 bankruptcy. Debtors are subject to a means test, and if income exceeds

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

Professional from academic institutions, pharmaceutical industries, health care indust

limits set by the government, the debtor must file under Chapter 13.

Chapter 13 bankruptcy is a reorganization plan for individuals. To qualify for Chapter 13, an individual must have sec

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

red and unsecured debts under a certain amount. Under Chapter 13 the debtor keeps all of their property, but in return they make regular payments to a trustee, who distributes the payments

.

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 the creditors. Most Chapter 13 plans last for three to five years, and then eligible debts are discharged. The types of debt that can be discharged under Chapter 13 was substantially s

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

Companies that provide selfless information through particip

aled back by the 2005 reform amendments. Creditors may challenge a Chapter 13 plan but a plan can still be confirmed over their objection if the criterion for confirmation is otherwise met

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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