21
Lifecycle Management Through the Rx-to-OTC Switch
brands combined represented over 70% of the
then $360 million OTC H2 antagonist cate-
gory.28 Boehringer-Ingelheim acquired Zantac,
which held a smaller share of the market, for
$509.5 million29 and began to invest in the brand
for growth. Although Zantac was removed from
the market by FDA in 2020 due to a carcino-
genic impurity,30 by then, US OTC retail sales
of Zantac had surpassed US OTC retail sales of
Pepcid: $156.5 million versus $110.2 million.31
Building switch awareness is required for
many different targets, not just the consumer
themselves. Doctors, managed care organizations,
and other healthcare professionals need to under-
stand that a prescription is no longer required
for the patient to purchase a particular product.
Retail pharmacists need to learn where the prod-
uct is now located in front of the counter so that
they can direct customers there. In other cases,
the OTC purchaser may be the caregiver, spouse,
or parent of the person for whom the OTC drug
is most appropriate.
Generating awareness, however, will only
result in trial (purchase) of the Rx-to-OTC
switch if the product is believed to deliver against
an unmet consumer need. After its prescription
approval in 1976, the H2 antagonist Tagamet
was the first drug in the US to achieve block-
buster status, with more than $1 billion in sales.32
Pepcid was a relatively late entrant (1986) to
the prescription H2 market but was approved as
an OTC product six weeks ahead of Tagamet.
Both brands spent more than $100 million to
generate initial awareness,33 and Tagamet hoped
to leverage its prescription heritage. While the
advertising wars became contentious, with both
parties suing the other for false claims,34 consum-
ers voted for Pepcid with their wallets. Despite
Tagamet’s stronger prescription heritage, Pepcid
was better able to deliver against consumer
needs with claims that it “prevents and relieves
heartburn,” whereas Tagamet at the time could
only claim to relieve heartburn. Furthermore, the
initially approved Tagamet dose was two tablets,
twice daily, whereas Pepcid could provide greater
benefits with a consumer-preferred dose of only
one tablet.
Market research is key to discovering unmet
consumer needs, and the marketing messages
that worked for a prescription product (with
physicians as the key target audience) may not
work for consumers. Brands need a way to effec-
tively communicate their meaningful difference.
Prilosec, for example, claims “one pill, every 24
hours, zero heartburn.” As the fourth entrant in
the non-sedating antihistamine category, Xyzal
created a differentiation by claiming that the
product “works while you sleep…so you wake up
more refreshed for a productive day.”35
Communication starts with the product’s
indication and the principal display panel (PDP).
When Differin was switched to OTC in 2016,
the package failed to explain the product’s ben-
efits. It was indicated as an “acne treatment” and
included key claims of “previously available only
by prescription,” “FDA approved,” “dermatologist
developed,” and “once daily topical retinoid.”36
The package left the consumer to wonder how
the newly switched product would provide better
relief than previously existing acne treatments.
As a prescription product, Flonase was
indicated for management of nasal symptoms of
allergic rhinitis. The Rx-to-OTC switch sponsor
proposed that the OTC product also be indi-
cated to treat ocular allergy symptoms of “itchy,
watery eyes.”37 Because clinical studies were
required to support the OTC approval of this
claim, FDA granted Hatch-Waxman exclusivity
for the ocular allergy indications, which differen-
tiated Flonase from other intranasal steroids and
from private label versions of fluticasone in the
OTC market.
Benefits that encourage trial must be
delivered without unwanted side effects. Alli
promised clinically proven weight loss, with
the most common side effect being a change in
bowel habits, which may include loose stools. The
product’s insert directs users to “make sure you
wear dark pants.” While the promise of weight
loss was very enticing, and the product achieved
sales of $155 million within a few weeks on the
OTC market,38 today US retail sales for Alli are
$19.6 million.39
The OTC product also must be easy to use.
Once a day dosing is preferred. Multiple doses
per day and non-oral administration will limit
compliance and reduce consumer satisfaction.
Dosage forms that convey benefits, such as
Lifecycle Management Through the Rx-to-OTC Switch
brands combined represented over 70% of the
then $360 million OTC H2 antagonist cate-
gory.28 Boehringer-Ingelheim acquired Zantac,
which held a smaller share of the market, for
$509.5 million29 and began to invest in the brand
for growth. Although Zantac was removed from
the market by FDA in 2020 due to a carcino-
genic impurity,30 by then, US OTC retail sales
of Zantac had surpassed US OTC retail sales of
Pepcid: $156.5 million versus $110.2 million.31
Building switch awareness is required for
many different targets, not just the consumer
themselves. Doctors, managed care organizations,
and other healthcare professionals need to under-
stand that a prescription is no longer required
for the patient to purchase a particular product.
Retail pharmacists need to learn where the prod-
uct is now located in front of the counter so that
they can direct customers there. In other cases,
the OTC purchaser may be the caregiver, spouse,
or parent of the person for whom the OTC drug
is most appropriate.
Generating awareness, however, will only
result in trial (purchase) of the Rx-to-OTC
switch if the product is believed to deliver against
an unmet consumer need. After its prescription
approval in 1976, the H2 antagonist Tagamet
was the first drug in the US to achieve block-
buster status, with more than $1 billion in sales.32
Pepcid was a relatively late entrant (1986) to
the prescription H2 market but was approved as
an OTC product six weeks ahead of Tagamet.
Both brands spent more than $100 million to
generate initial awareness,33 and Tagamet hoped
to leverage its prescription heritage. While the
advertising wars became contentious, with both
parties suing the other for false claims,34 consum-
ers voted for Pepcid with their wallets. Despite
Tagamet’s stronger prescription heritage, Pepcid
was better able to deliver against consumer
needs with claims that it “prevents and relieves
heartburn,” whereas Tagamet at the time could
only claim to relieve heartburn. Furthermore, the
initially approved Tagamet dose was two tablets,
twice daily, whereas Pepcid could provide greater
benefits with a consumer-preferred dose of only
one tablet.
Market research is key to discovering unmet
consumer needs, and the marketing messages
that worked for a prescription product (with
physicians as the key target audience) may not
work for consumers. Brands need a way to effec-
tively communicate their meaningful difference.
Prilosec, for example, claims “one pill, every 24
hours, zero heartburn.” As the fourth entrant in
the non-sedating antihistamine category, Xyzal
created a differentiation by claiming that the
product “works while you sleep…so you wake up
more refreshed for a productive day.”35
Communication starts with the product’s
indication and the principal display panel (PDP).
When Differin was switched to OTC in 2016,
the package failed to explain the product’s ben-
efits. It was indicated as an “acne treatment” and
included key claims of “previously available only
by prescription,” “FDA approved,” “dermatologist
developed,” and “once daily topical retinoid.”36
The package left the consumer to wonder how
the newly switched product would provide better
relief than previously existing acne treatments.
As a prescription product, Flonase was
indicated for management of nasal symptoms of
allergic rhinitis. The Rx-to-OTC switch sponsor
proposed that the OTC product also be indi-
cated to treat ocular allergy symptoms of “itchy,
watery eyes.”37 Because clinical studies were
required to support the OTC approval of this
claim, FDA granted Hatch-Waxman exclusivity
for the ocular allergy indications, which differen-
tiated Flonase from other intranasal steroids and
from private label versions of fluticasone in the
OTC market.
Benefits that encourage trial must be
delivered without unwanted side effects. Alli
promised clinically proven weight loss, with
the most common side effect being a change in
bowel habits, which may include loose stools. The
product’s insert directs users to “make sure you
wear dark pants.” While the promise of weight
loss was very enticing, and the product achieved
sales of $155 million within a few weeks on the
OTC market,38 today US retail sales for Alli are
$19.6 million.39
The OTC product also must be easy to use.
Once a day dosing is preferred. Multiple doses
per day and non-oral administration will limit
compliance and reduce consumer satisfaction.
Dosage forms that convey benefits, such as