Wouldn’t it just be wonderful if there were opportunities to become the first generic on the market and not have to deal with patent litigation? Using
the PharmaCompass database, we ran a
check for products which are currently on market, without generic competition,
however have no patents listed in the FDA orange book. FDA
is required by law to publish approved drug products and this publication is
commonly called the Orange Book. While
this may sound surprising, since almost all brand-name innovator drugs have
patents listed in the Orange Book, we did find some multi-million dollar
products without any patent listings. The benefit of no patent listings No patent
listings on the FDA orange book prevent the opportunity for the brand
manufacturer to use a legal provision that delays the launch of a generic
version of the product by up to 30 months. Lowered
litigation costs, increased probability of an early entry to market combined
with a higher share of a multi-million dollar market are all the elements of a dream
product launch. The
opportunities certainly seem too good to be true and our analysis came up with
an interesting list of products which we have shared below. Lundbeck’s Sabril, a perfect example With
almost $115 million in sales which grew
at 35% in 2014, Lundbeck’s Sabril (Vigabatrin) had its
non-patent, market exclusivity granted, by the FDA, to a new chemical entity
expire last year. The
product is still protected by some other marketing exclusities granted for new
patient populations (expiry 2016) and pediatric patients (expiry 2017), Sabril
presents a perfect example where generics can anticipate windfall profits.
However, some generic companies are already started targeting the Sabril (Vigabatrin) opportunity
based on our review of the export price data on PharmaCompass. Lundbeck’s Onfi & Northera Interestingly
Lundbeck has two other products, Onfi (Clobazam) and Northera (Droxidopa) also on
the list. The exclusivity protection of Onfi is scheduled to expire next year and
generic competition will be a setback for Lundbeck as Onfi brought in almost
$150 million in sales in 2014, a 61% increase over 2013. Droxidopa’s exclusivity protection runs out much longer (2019) as the product only obtained approval last year. However, Lundbeck has great hopes for this drug as it paid $658 million to buy the drug as
soon as it was approved. Polidocanol’s $500 million sales potential Polidocanol, used in the
treatment of spider (varicose) veins, was first approved in 2010 under the
brand name Asclera. No patents were listed in the Orange Book and the market
exclusivity on the product expired in March this year. In
2013, a new formulation of Polidocanol was launched by U.K. based, BTG
International, and they expect to achieve sales of $500 million
with the product. However, this time there are patents listed in the Orange
book! Other examples Diagnostic
agents, like Dotarem (Gadoterate
Meglumine), Choline C-11 and Lumason (Sulfur Hexafluoride
Lipid Microspheres) are also examples of products which are covered by
non-patent exclusivity protections. Dotarem, already approved in 70 countries, is
used in magnetic resonance imaging (MRI) of
the brain, spnine and associated tissues while Lumason helps physicians see the heart clearer when
the ultrasound image is hard to see. The
generic launch of Apotex’s Ferriprox (Deferiprone) in 2016
will be interesting since our database shows four potential challengers who
have U.S. Drug Master Files submitted for the product. However, two of these
four companies (Aarti Drugs
& Emcure Pharmaceuticals)
are on the U.S. FDA import alert list and hence banned from supporting a
generic launch. Glaxo’s Potiga (Ezogabine) is Big Pharma’s representative on our list. The drug, used to treat certain types of epilepsy, when launched was expected to have sales between $200-800 million.
The current sales have however been well below expectations as the drug was found
to be associated with risks
of skin discoloration and eye abnormalities. Uncommon business There
are some drugs on this list which are for uncommon diseases. Carglumic Acid and Miltefosine both address orphan
drug populations, however, they have also made recent headlines. Carglumic acid
is the most expensive drug per prescription dispensed
in the United States. Miltefosine, on the other hand, got
approval for tropical diseases which almost never occur in the country! Knight
Therapeutics, which got awarded the approval was not really depending on the sales
of the product. Along with the product approval they received a Neglected Tropical Disease Priority Review Voucher. The voucher reduces the review period of a new drug
application from the standard 10 months to 6. Since blockbuster drugs make
hundreds of millions of dollars in sales every month, a launch four months
earlier could mean an extra few billion dollars in revenue. Hence, it wasn’t surprising when in November 2014, Gilead Sciences purchased the voucher from Knight for $125 million. The next priority review voucher was sold, two months ago, for an incredible $245 million dollars, generating a new multi-million dollar business of developing products for diseases which have almost no patients! Our View It
is difficult to imagine that, with the stakes involved and the nature of the
pharmaceutical business, there will be no litigation when a generic tries to
take away market share from the innovator.
However, a list of products with no patents in the Orange Book does give
generics new opportunities to think about.
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