17
Lifecycle Management Through the Rx-to-OTC Switch
categories is smoking cessation. The good news is
that smokers can and do quit smoking for good.
In fact, since 2002, there have been more former
smokers than current smokers.11
Current smoking has declined from 20.9%
(nearly 21 of every 100 adults) in 2005 to 14.0%
(14 of every 100 adults) in 2019.12
The current total US retail category size
for antismoking products is under $1 billion, at
$974 million.13 Recent drug store sales figures
demonstrate that distribution in this channel
is essentially limited to one brand and private
label products. Table 2-6 shows the dollar share
that private label products have obtained in the
smoking cessation category.
The high share of private label products indi-
cates that many consumers do not feel that the
branded products are significantly innovative or
can justify a premium price. In this case, consum-
ers could be very open to trying an Rx-to-OTC
switch product that addresses unmet needs. For
the switch sponsor, however, the decreasing size
of the smoking cessation category and potential
challenges in securing retail placement could limit
the long-term value of the switch program spon-
sors would need to move forward with caution.
Assessing category dynamics becomes much
more difficult for an Rx-to-OTC category that
does not currently exist. Many marketers look
at epidemiology when assessing the potential
for new OTC categories to determine how
many consumers need a particular solution and
potential sources of volume. Certainly, many
people suffer from overactive bladder (OAB).
The size of the North American prescription
OAB market is valued at $1.15 billion in 2020.14
With 20 million OAB sufferers in the US,15
Merck Consumer Care switched the OAB patch
Oxytrol (oxybutynin) to OTC for women in
early 2013. Oxytrol was not a well-known brand
from its original approval in 2003 through 2011,
only 40 million patches had been sold.16 As an
OTC product, Oxytrol for women only gar-
nered $29 million in sales in its first year in the
market.17 With disappointing OTC sales, the
product was discontinued in early 2015.18 There
are a number of reasons why this first-in-class
switch failed commercially, and it is difficult to
assess whether a different, more well-established
prescription drug for OAB would be commer-
cially successful as an OTC.
Table 2-3. Allergy Brands Launched as a Result of Rx-to-OTC Switch and Their Most Recent Annual
US Retail Sales
Brand Drug Drug Class Year of First
Switch
Annual US Retail
Sales (in Millions)
Claritin Loratadine Non-sedating antihistamine 2002 $530.3
Zyrtec Cetirizine Non-sedating antihistamine 2007 $510.0
Allegra Fexofenadine Non-sedating antihistamine 2011 $309.3
Nasacort triamcinolone acetonide Intranasal steroid 2013 $66.7
Flonase fluticasone propionate Intranasal steroid 2014 $227.4
Rhinocort Budesonide Intranasal steroid 2015 $7.4
Xyzal Levocetirizine Non-sedating antihistamine 2017 $91.4
Note: The prescription drug Veramyst, which contained a different salt, fluticasone furoate, was switched to OTC in
2016 as Flonase SensimistTM retail sales shown are for the entire Flonase franchise.
Source: Symphony IRI Latest 52 Week MULO sales for the period ending 12 July 2020.
Table 2-4. Source of Volume for Recent Allergy
Rx-to-OTC Switches
Product Year Rx OTC
Claritin 2002 49% 24%
Zyrtec 2007 53% 36%
Allegra 2011 46% 43%
Flonase 2014 20% 50%
Source: Year 1 volume data from Symphony IRI.
Lifecycle Management Through the Rx-to-OTC Switch
categories is smoking cessation. The good news is
that smokers can and do quit smoking for good.
In fact, since 2002, there have been more former
smokers than current smokers.11
Current smoking has declined from 20.9%
(nearly 21 of every 100 adults) in 2005 to 14.0%
(14 of every 100 adults) in 2019.12
The current total US retail category size
for antismoking products is under $1 billion, at
$974 million.13 Recent drug store sales figures
demonstrate that distribution in this channel
is essentially limited to one brand and private
label products. Table 2-6 shows the dollar share
that private label products have obtained in the
smoking cessation category.
The high share of private label products indi-
cates that many consumers do not feel that the
branded products are significantly innovative or
can justify a premium price. In this case, consum-
ers could be very open to trying an Rx-to-OTC
switch product that addresses unmet needs. For
the switch sponsor, however, the decreasing size
of the smoking cessation category and potential
challenges in securing retail placement could limit
the long-term value of the switch program spon-
sors would need to move forward with caution.
Assessing category dynamics becomes much
more difficult for an Rx-to-OTC category that
does not currently exist. Many marketers look
at epidemiology when assessing the potential
for new OTC categories to determine how
many consumers need a particular solution and
potential sources of volume. Certainly, many
people suffer from overactive bladder (OAB).
The size of the North American prescription
OAB market is valued at $1.15 billion in 2020.14
With 20 million OAB sufferers in the US,15
Merck Consumer Care switched the OAB patch
Oxytrol (oxybutynin) to OTC for women in
early 2013. Oxytrol was not a well-known brand
from its original approval in 2003 through 2011,
only 40 million patches had been sold.16 As an
OTC product, Oxytrol for women only gar-
nered $29 million in sales in its first year in the
market.17 With disappointing OTC sales, the
product was discontinued in early 2015.18 There
are a number of reasons why this first-in-class
switch failed commercially, and it is difficult to
assess whether a different, more well-established
prescription drug for OAB would be commer-
cially successful as an OTC.
Table 2-3. Allergy Brands Launched as a Result of Rx-to-OTC Switch and Their Most Recent Annual
US Retail Sales
Brand Drug Drug Class Year of First
Switch
Annual US Retail
Sales (in Millions)
Claritin Loratadine Non-sedating antihistamine 2002 $530.3
Zyrtec Cetirizine Non-sedating antihistamine 2007 $510.0
Allegra Fexofenadine Non-sedating antihistamine 2011 $309.3
Nasacort triamcinolone acetonide Intranasal steroid 2013 $66.7
Flonase fluticasone propionate Intranasal steroid 2014 $227.4
Rhinocort Budesonide Intranasal steroid 2015 $7.4
Xyzal Levocetirizine Non-sedating antihistamine 2017 $91.4
Note: The prescription drug Veramyst, which contained a different salt, fluticasone furoate, was switched to OTC in
2016 as Flonase SensimistTM retail sales shown are for the entire Flonase franchise.
Source: Symphony IRI Latest 52 Week MULO sales for the period ending 12 July 2020.
Table 2-4. Source of Volume for Recent Allergy
Rx-to-OTC Switches
Product Year Rx OTC
Claritin 2002 49% 24%
Zyrtec 2007 53% 36%
Allegra 2011 46% 43%
Flonase 2014 20% 50%
Source: Year 1 volume data from Symphony IRI.