23
Lifecycle Management Through the Rx-to-OTC Switch
Assessing Rx-to-OTC Switch Value—
Ability to Innovate
The ability to innovate is a crucial consideration
for the long-term success of an Rx-to-OTC
switch brand. Driving innovation requires
investments in market research, new product
development, and NDAs. OTC innovation
plans should be considered when the initial
Rx-to-OTC switch plan is being developed. For
large companies, global approval processes may
need to be planned and coordinated. Innovation
strategies can include combination prod-
ucts (Zantac Duo Fusion), new dosage forms
(Nexium ClearminisTM), novel packaging, use
of trademarks for sub-branding (Claritin Eye),
new claims (Claritin “alert and focused”), new
uses and indications (Claritin Hives), adjacencies
(Allegra Anti-Itch), extended-release, and/or
higher doses (Zantac 150). (It is worth men-
tioning here that Claritin’s follow-on strategy
to gain the “hives” indication also enabled all Rx
products to be removed from the market, which
had remained available by prescription for the
indication “chronic idiopathic urticaria.”) Advil,
originally switched to OTC in 1984, remains
the internal analgesic brand leader by continuing
to invest in the development of new (direct-to-
OTC) NDAs. Table 2-11 contains a list of new
Advil products approved via NDAs since the
original Rx-to-OTC switch.
One of the keys to success, therefore, is the
ability to create a “billboard” at the retail shelf,
as a single shelf keeping unit (SKU) would be
Table 2-10. Order of Entry for Various Rx-to-OTC Switches (by Class) Versus Current Sales Rank
Brand Order of Entry Current US Sales Rank
Non-sedating antihistamines Claritin 1 1
Zyrtec 2 2
Allegra 3 3
Xyzal 4 4
H2 antagonists Pepcid 1 1
Tagamet 2 2
Zantac 3 Recently leading H2 until withdrawal
Axid 4 Discontinued due to low sales
PPIs Prilosec 1 2
Prevacid 2 4
Zegerid 3 3
Nexium 4 1
Intranasal steroids Nasacort 1 2
Flonase 2 1
Rhinocort 3 3
Source: Symphony IRI Latest 52 Week MULO sales for the period ending 12 July 2020.
Table 2-11. Advil Products Approved via new
NDAs (and Year of Approval)
Product Year of Approval
Advil 1984
Advil Cold &Sinus 1989
Advil Liquigels 1995
Advil Migraine Liquigels 2000
Children’s Advil Cold 2002
Advil PM 2005
Advil Congestion Relief 2010
Advil Dual Action 2020
Lifecycle Management Through the Rx-to-OTC Switch
Assessing Rx-to-OTC Switch Value—
Ability to Innovate
The ability to innovate is a crucial consideration
for the long-term success of an Rx-to-OTC
switch brand. Driving innovation requires
investments in market research, new product
development, and NDAs. OTC innovation
plans should be considered when the initial
Rx-to-OTC switch plan is being developed. For
large companies, global approval processes may
need to be planned and coordinated. Innovation
strategies can include combination prod-
ucts (Zantac Duo Fusion), new dosage forms
(Nexium ClearminisTM), novel packaging, use
of trademarks for sub-branding (Claritin Eye),
new claims (Claritin “alert and focused”), new
uses and indications (Claritin Hives), adjacencies
(Allegra Anti-Itch), extended-release, and/or
higher doses (Zantac 150). (It is worth men-
tioning here that Claritin’s follow-on strategy
to gain the “hives” indication also enabled all Rx
products to be removed from the market, which
had remained available by prescription for the
indication “chronic idiopathic urticaria.”) Advil,
originally switched to OTC in 1984, remains
the internal analgesic brand leader by continuing
to invest in the development of new (direct-to-
OTC) NDAs. Table 2-11 contains a list of new
Advil products approved via NDAs since the
original Rx-to-OTC switch.
One of the keys to success, therefore, is the
ability to create a “billboard” at the retail shelf,
as a single shelf keeping unit (SKU) would be
Table 2-10. Order of Entry for Various Rx-to-OTC Switches (by Class) Versus Current Sales Rank
Brand Order of Entry Current US Sales Rank
Non-sedating antihistamines Claritin 1 1
Zyrtec 2 2
Allegra 3 3
Xyzal 4 4
H2 antagonists Pepcid 1 1
Tagamet 2 2
Zantac 3 Recently leading H2 until withdrawal
Axid 4 Discontinued due to low sales
PPIs Prilosec 1 2
Prevacid 2 4
Zegerid 3 3
Nexium 4 1
Intranasal steroids Nasacort 1 2
Flonase 2 1
Rhinocort 3 3
Source: Symphony IRI Latest 52 Week MULO sales for the period ending 12 July 2020.
Table 2-11. Advil Products Approved via new
NDAs (and Year of Approval)
Product Year of Approval
Advil 1984
Advil Cold &Sinus 1989
Advil Liquigels 1995
Advil Migraine Liquigels 2000
Children’s Advil Cold 2002
Advil PM 2005
Advil Congestion Relief 2010
Advil Dual Action 2020