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Delay ANDA Past June 19, 2014 to Save Money?

Money SavingAt first glance it seems obvious, submit your ANDA(s) before June 20, 2014, when the FDA increases the stability requirement from one batch to three batches to save money.  However, there are other things to consider.  This scenario is similar to what happened in September 2012 right before GDUFA started.

In September 2012, everyone rushed to get their submission filed before the full ANDA fee (approximately $51,000 at that time) came into effect by submitting their application before October 1, 2012.  This way a company only had to pay the backlog fee (approximately $17,000).  This essentially saved companies about $35,000.  However, in looking back what is the true cost of this action.  Yes, the filing fee was less but in looking at the GDUFA legislation.  It states 90% of the backlog applications will be acted on by the end of FY2017.  Think about this for a moment, the FDA operates with a First In First Out approach.  Which means those applications submitted in September 2012 are at the tail end of the backlog applications and should hear back sometime in 2017 or later.  This is much longer than typical approval times and will cost years on the market. All in the name of saving $35,000.

Jumping to today, industry is repeating this same short sighted savings.  Let's summarize what we know.

  • FDA will require 3 batches and six month stability.

  • GDUFA time lines come into effect for the first time October 1, 2014 which a target date of 15 months.

  • All submissions (excluding priority or Paragraph IV submissions) have no required time lines for review.

  • The FDA has heavily advertised how they have  met or exceeded all GDUFA requirements.

  • There will be essentially zero ANDA filings between June 20, 2014 and October 1, 2015.

In looking at the aforementioned facts,  we can easily see that there will be extra costs in the manufacture of the three batches and time lost in the acquisition of the extra three months of stability data.  The extra costs translates comes from extra API cost, manufacturing costs and stability costs.  However, in many cases there is some reduction in costs due to the use of bracketing and matrixing which can be employed with the three batch approach.  That being said there is an extra cost which is substantial.

All applications currently filed have no review time frame associated with them, we have seen variability in receiving responses between 20-30 months from the time of filing.  Obviously, there are many factors that cause this variation and many products are outside of this variation both longer and shorter. In any event, it much longer than the 15 months promised by the FDA starting October 1, 2014.  Additionally, with essentially no submissions being submitted between June and October, the FDA will be able to get organized for the new submissions that will have target dates associated with them.  Based on this, you lose three to four months waiting for the stability data but gain on average 9-12 months in review time.  Doing simple math, the time savings are about half a year (6 months).

This obviously assumes that the FDA will achieve their time frames but based on the most recent FDA presentations they will do what they can and considering it is the first time target dates are in effect. I am sure at least initially they will.  Other target dates, related to amendments will affect both submission types equally.

The final consideration is the status of your facility. If you have a facility that is filing a generic application for the first time, then there are establishment fee savings.  The FDA has stated that facility fees are due whenever a facility for the first time has a referencing application active, submitted or pending on the due date.  This means, if you submit in October 2, 2014 then your first establishment fee is due October 1, 2015.  This with the shortened review time will result in the removal of one or two establishment fees prior to you approval.  Currently the establishment fee is about $220,000 for domestic facilities and $235,000 for foreign facilities.  This fee is an annual fee subject to change yearly.  For facilities filing an ANDA for the first time the savings are significant.

In conclusion, there are several factors that define a companies path forward with respect to the timing of the filings. Many companies as pressing very hard to meet the June 19, 2014 filing time frame with the goal of saving money and time.  Companies should evaluate the big picture to determine what is best long term as opposed to just looking at today.  If you are pressing too hard complete a filing, the odds of having mistakes in that submission and therefore receiving a Refuse to Receive increase drastically.  This has enormous consequences in lost fees, API costs, manufacturing costs, testing costs and most importantly time.

For assistance contact, Fred Defesche via email at or via phone at 760-481-7811.

GDUFA Fees announced by FDA, all companies must Self Identify.

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According to the FDA's 2013 generic drug user fee:

ANDA's submitted on or after October 1, 2012 must pay $51,520

ANDA's submitted prior to October 1, 2012 not yet approved must pay a backlog fee of $17,434

Prior approval supplement (PAS) submitted on or after October 1, 2012 must pay $25,760.

DMF's submitted on or after October 1, 2012 must pay $14,940.

Fees are due on the date of submission.

If an ANDA or PAS was submitted before October 1, 2012 the fees are due on November 24.


**All companies must Self Identify, this will allow the FDA to track fees.  Custopharm can assist companies with filing their Self Identifier electronic filing.


Any questions please contact Dave McCleary @ 203 306-7819 or



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Custopharm provides a turn-key solution to Foreign Companies interested in selling their generic products in the US

describe the imageCustopharm provides a ''turn-key" solution to Foreign companies interested in selling their products in the US Market, we have supported companies from every continent.  Many companies have interest in expanding markets for their generic products, especially the US market.  

It is not necessary to open a US office, this can cost millions of $ before you have FDA approval on your first generic product. 

Custopharm has a great deal of experience, we have supported more than 50 companies around the world.  (Australia, Bangladesh, Brazil, Canada, China, Croatia, France, Germany, Greece, India, Italy, Poland, Portugul, Spain, Turkey, and others. 

We have assisted our overseas customers by serving as the US Agent, reviewing their documentation prior to manufacturing the stability batch, then submitting the eCTD ESG ANDA and responding to deficiencies. 

Also have a program where we review the documentation that will be used for the qualification batch, perform a gap analysis as to what the FDA regulations require, this helps reduce the number of unnecessary deficiencies. 

Custopharm can also provide the regulatory maintenance function once the product is approved.

Custopharm filed the first eCTD ANDA in 2004, have filed well over 100 since.  We have 9 years of experience with eCTD filings.  Currently filing 2 eCTD ESG ANDA's per month.  We have a staff of 12 qualified individuals assisting with the effort.

Our fees are ‘all inclusive’ until the application is approved by the FDA.  The beauty of the ‘all inclusive’ pricing is that our goal is to get your approval as soon as possible, we are not focused on billable hours.  Our companies share the same goal, both make more money by moving the application through the process quicker.  You will never have to go to your owners/board and tell them there are additional fees/add-ons, a budget you can depend on.

Custopharm provides a reliable service, we have a great deal of interaction with the FDA reviewers during the approval process.  The applications we ‘fully write’ are approved sooner than the ANDA’s we publish, in many cases there is a significant improvement in approval times.  The deficiency responses are all written in a way that is acceptable to the FDA, we filed over 100 deficiency responses in 2010, over 100 deficiency responses in 2011, this provides a valuable benefit to your company.  Minimizing the severity of the first round of deficiencies and reducing the number of review cycles is ‘paramount’ to Custopharm.

ANDA approval times for our customers are significantly quicker than the industry average.

Custopharm can also connect you with US Marketing companies that can distribute your products.

If interested please contact:

Dave McCleary

Custopharm, Inc.


(760) 481-7590  office

(203) 306-7819  cell

Answer to the US Generic Drug Shortage Problem - Economics


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Interesting article from the WSJ - 11/2/11  This IS the solution - allow companies to make money on products in demand.

The Bush-Obama Rx Shortages

Critical cancer drugs are in short supply thanks to price controls.


This week President Obama finally confronted a major U.S. health-care disgrace—the growing shortages of lifesaving drugs, especially anticancer therapies. For some reason the White House lumped its executive order with its "we can't wait" campaign against House Republicans, but the pity is that we will have to wait, because the only genuine fix is a liberal anathema: market prices.

Shortages have more than tripled since 2005, according to the University of Utah's Drug Information Service, and by the end of the year more than 300 products are likely to be back-ordered, in short supply or totally unavailable. Some are anesthetics and pain therapies, others emergency room "crash cart" drugs. But most—about 70% in 2010—belong to the class of drugs known as "sterile injectables" that are mainstays of the chemotherapy arsenal, such as paclitaxel or cytarabine.

The result is that more and more patients are receiving substandard care—relying on less effective or more expensive substitutes or else forced to postpone treatment. In oncology, delays of weeks or even days can be fatal.

Most sterile injectables have been off-patent for decades, but unlike other cheap generic drugs with low profit margins, production is complex and requires special facilities. Nonetheless, George W. Bush and the Republican majority decided that Medicare was "overpaying" for these cancer drugs and included a 6% cap on price increases every six months in the 2003 prescription drug bill. These new price controls (which apply to the providers that purchase the drugs) took effect in 2005, when the shortages began.

In a rational market, sterile injectable prices would now be rising to encourage more supply, since the demand for cancer drugs is inelastic. The old reimbursement system, called "buy and bill," was imperfect, but at least it allowed prices to float and wasn't producing the scarcity that central planning always does. The sterile injectables that are in short supply currently sell for $37.88 a dose on average, and modest price increases could make the market economic.

The problem is compounded because Food and Drug Administration rules cause pointless delays. It takes as long as two and a half years to receive FDA manufacturing approval for a generic, so other drug makers can't ramp up production if a company cancels a product line due to these disincentives or even if the fragile supply chain for sterile injectables is contaminated and manufacture is delayed.

Mr. Obama's executive order will do little if any good since it doesn't address or even mention this underlying distortion that Medicare has created. Instead, it merely expands the FDA reporting requirements about production interruptions or terminations. This is supposed to be an early warning system, but the scandal is that the availability of basic medicines could be allowed to become an emergency.

The order also tells the Justice Department to crack down on the "grey markets" that have sprung up to deliver supplies to doctors and hospitals, albeit with the inevitable markups. So rather than allow price signals to govern supply and demand, Mr. Obama wants to suppress them further.

The larger danger apart from the risks to the patients forced to receive compromised treatment is to the future of cancer progress. The common chemotherapy drugs are critical in clinical trials as the standard regimen or in combination with new options, and the Coalition of Cancer Cooperative Groups reports that as many as half of all ongoing trials require the drugs that are vanishing. This is a delay that really is killing people.


WSJ - November 2nd, 2011

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