With almost 30,000 Drug Master Files (DMFs) submitted to the
FDA, reviewing the filings of only the first quarter of 2015, provides an
indicator on the current areas of focus of generic pharmaceutical companies. A
detailed evaluation of the 241 filings for active pharmaceutical ingredients only,
made us find some interesting trends worth sharing.
European Blockbuster
battle!
Of the 241 DMFs, 21 APIs had more than one DMF filing and
accounted for 25% of the total filings. Interestingly, 20 DMFs were for only three APIs:
AstraZeneca’s blood thinner Brilinta® (Ticagrelor), with 2014 sales of $476
million, already had DMF filings from Dr. Reddy’s, Mylan,
Polpharma and
Zhejiang Hisun at the end of last year. With a maximum of 9 new filings from players
like Teva,
Alembic, Lek and
others, AstraZeneca
should brace itself for some serious generic onslaught.
While the 9 filings for Ticagrelor were the most for any
single compound, not far behind is Bayer’s own blood thinner: Xarelto® (Rivaroxaban). With 7 submissions, the
focus of the generic companies is understandable as Rivaroxaban had sales in
excess of $3 billion and year-on-year growth in excess of 70%. However, patents
currently protect the product till 2020, so patience is needed before generics can
access this golden opportunity.
Interestingly, 4 filings for Linagliptin (Boehringer’s antidiabetic Tradjenta®) make it yet another European pharma giant lead the list of products being subjected to generic competition, and make us wonder why European blockbusters are preferred over others?
Exclusive but not
patented
There are products, which have no patent protection, but the
market is protected by FDA granted exclusivities (learn more on patents
and exclusivities from the FDA website).
An opportunity for generic companies to gain significant
market share of a multi-hundred million dollar market, without any litigation
risk or cost is something companies dream about.
As the time of exclusivity expiry nears, Clobazam, Tetrabenazine,
Hydroxyprogesterone Caproate, Deferiprone
and Trypan Blue
will all see increased generic activity as their Drug Master Files have been
submitted.
Fragmented Activity
More than 80% of the DMF submissions were made by companies
who filed only a single product. While the products varied from simple compounds
like Sodium Chloride to biologics like Plasmid DNA, over 140 companies filed DMFs in
the first quarter with almost 30 submitting a DMF for the first time.
An expanding list of suppliers who support DMFs increases
options for sourcing managers. However,
a fragmented supplier base limits the industrial scale companies can achieve and
raises concerns regarding how many can successfully sustain compliance standards
under increased regulatory scrutiny?
The Next Generic Wave
Blood thinners are an opportunity few generic companies wish to pass on. Boehringer’s (Dabigatran Etexilate), Bristol-Myers Squibb’s (Apixaban) and Bayer’s (Rivaroxaban) are novel compounds in this category which had combined sales in excess of $5 billion last year.
While Dagibatran saw a flurry of activity over the last two
years with almost 15 DMF filings, there were no additional filings this year.
On the other hand, Apixaban, which generated $774 million
for Bristol-Myers Squibb in 2014, has only one DMF filing at the moment and that too was done
over a year ago. The export data out of India, reviewed on PharmaCompass, for
Apixaban, indicates that product development is already complete so it is just
a matter of time before the filings begin.
Conclusion:
Product and supplier selection is a critical component of every generic company’s strategy. The PharmaCompass database is designed to assist professionals in business development, marketing and sourcing to take more informed decisions.
If you would like us to share our shortlist of 241 DMFs, we will be happy to send it to you by email (click here). You can also access our compilation of the 2014 annual reports of
major pharmaceutical companies to review the various products along with their
revenues (click here):
Table: Products with more than one DMF filing in Q1 2015
PRODUCT NAME
DMF FILINGS
TICAGRELOR
9
RIVAROXABAN
7
LINAGLIPTIN
4
APREPITANT
3
CINACALCET HYDROCHLORIDE
3
ATAZANAVIR SULFATE
2
ATORVASTATIN CALCIUM TRIHYDRATE
2
CLOBAZAM
2
CLOFARABINE
2
DEFERASIROX
2
DIMETHYL FUMARATE
2
EZETIMIBE
2
ICATIBANT ACETATE
2
LURASIDONE HYDROCHLORIDE
2
MELPHALAN HYDROCHLORIDE
2
OLANZAPINE
2
OLMESARTAN MEDOXOMIL USP
2
PRASUGREL HYDROCHLORIDE
2
RIVASTIGMINE USP
2
ROSUVASTATIN CALCIUM
2
SOLIFENACINE SUCCINATE
2
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