Generic Challenges, The Next First-to-Files, GDUFA Dues (FY 2016)

Generic challenges, the next first-to-files, GDUFA dues (FY 2016) and more

PharmaCompass has assessed the second quarter US Drug Master File (DMFs) filings. In our view, with five potential first-to-file (FTF) applications along with another five DMFs challenging markets that have been monopolized for decades, the pharmaceutical industry in the United States should brace itself for some serious shakeups.

Unlike the first quarter of 2015 where 241 new DMF filings were listed on the USFDA site, this quarter saw a reduction of almost 35 percent in the DMFs filed. As DMFs form a critical part of the regulatory submissions made by generics to challenge innovator companies, a reduction in filings, in the recent quarter, seems to bear no correlation with the disruption the market will potentially witness in times to come.

The ‘first-to-file’ disruptors

Profits in the generic pharmaceutical business are highly dependent on how quickly a drug is introduced in the market. The ‘first-to-file’ generic is a coveted position, since the company is legally granted a 180-day period of market exclusivity, where no other generic can be in the market. This six month exclusivity invariably leads to windfall gains for the company.

This quarter DMFs were received by the FDA, which could potentially drive the first-to-file challenges against J&J’s blockbuster Inovkana (canagliflozin), Eisai’s Belviq (lorcaserin hydrochloride), Incyte’s Jakavi (ruxolitinib phosphate), Celgene’s Pomalyst (pomalidomide) and Akorn’s Zioptan (tafluprost).

However, given the complexities involved in bringing a generic product to market, the first DMF filing does not always result in the first generic challenge to the brand drug. The second DMFs filed for a product are also strong contenders which must not be ignored. For example, Glenmark recently filed their DMF for tofacitinib, almost 18 months after serial-DMF filing by MSN Pharmaceuticals. But Glenmark has moved ahead by already getting their DMF reviewed by the FDA.

Similarly, while Alp Pharma Beijing’s dapagliflozin, Perrigo’s ferric citrate and Amino Chemicals’ miglustat are the second DMFs to be received by the FDA, the innovator should start counting the days before they are plagued by generic challengers.

Exclusively not-patented

For several years, Indian companies have been leading many first-to-file generic challenges in the United States. However, as they have scaled up in size, the same companies have also obtained rights to some exclusive markets in the United States; either through acquisitions or alliances.

Sun Pharmaceutical’s US $ 230 million acquisition of dermatology specialist Dusa was triggered by the successful sales of Dusa’s photo-chemotherapy treatment, Levulan. German Midas Pharma GmbH’s filing will not only subject Sun’s market domination to generic competition, the fact that there are six other DMFs filed for this product (of which none of the filings have come from Indian or Chinese companies) indicates a change in the way the industry is beginning to operate.

Like Sun Pharmaceutical’s monopoly of Levulan, Dr. Reddy’s has enjoyed no competition for their topical treatment, Cloderm (clocortolone pivalate) since 2011 when they purchased the rights for the product by making an upfront payment of US $ 36 million to Canadian, Valeant Pharmaceuticals. Dr. Reddy’s needs to start monitoring the progress of Italian Trifarma’s filing since this is the fifth time a DMF for this product has been received by the FDA.

Indian companies aside, Aspen’s Leukeran, Bausch & Lomb’s Zirgan, Mission Pharmaceuticals’ Thiola and GSK’s topical treatment Abreva have all marketed their products without any competition. The DMF filings of this quarter indicate that generics have narrowed in on the profits being made and the market dynamics for these products will change in the future.

Down, but not out

Intriguingly, companies like Apotex Pharmachem, Emcure Pharmaceuticals and Global Calcium are currently on the FDA Import Alert list and banned from exporting products to the United States since they did not operate in conformity with the current good manufacturing practices (GMP's).

However, these companies are definitely optimistic about their future since they have all filed new DMFs this quarter. It remains to be seen if the bans will get lifted in the near future.

This quarter also saw Dr. Reddy’s get creative in their challenge to Japanese Astellas Pharma’s leaky bladder treatment, Myrbetriq (mirabegron). After having filed a DMF last year, they re-filed again recently, with a different polymorphic form, to potentially circumvent the patents around this product.

Our support

Generic pharmaceutical companies are continuously looking for opportunities where they can get the maximum possible market share in the fastest way possible.

While the number of manufacturers of active pharmaceutical ingredients (APIs) keep increasing, we are also witnessing an increase in the cost of regulatory support required to sustain the production of these APIs.

The industry is becoming more challenging – identifying target markets is becoming a science which requires high-level management focus.

In order to help you, PharmaCompass will share its compilation of this quarter’s DMF filing list. Just send us an email by clicking here and we’re happy to support you in every possible way.

Last week, the FDA also announced the fee dues (as on October 1, 2015), as per the Generic Drug User Fee Act (GDUFA). We are sharing the amounts due, in case you have not been able to access this information.

FISCAL YEAR AND FEE TYPE	2014 (Rate)	2015 (Rate)	$ & % Difference from previous year
Abbreviated New Drug Application	$63,860	$58,730	-$5,130 (-8.0%)
Prior Approval Supplement	$31,930	$29,370	-$2,560 (-8.0%)
Drug Master File	$31,460	$26,720	-$4,740 (-15.1%)
Finished Dosage Form Facility	$220,152 (Domestic)	$247,717 (Domestic)	$27,565 (12.5%)
	$235,152 (Foreign)	$262,717 (Foreign)
Active Pharmaceutical Ingredient Facility	$34,515 (Domestic)	$41,926 (Domestic)	$7,411 (21.5%)
	$49,515 (Foreign)	$56,926 (Foreign)

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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