Chapter 2: Why Switch? Evaluating the Value of Switch Candidates
28
Long-term Rx-to-OTC switch success requires
the ability to innovate and generate “new news”
to maintain awareness, generate trial and drive
brand loyalty. Successful Rx-to-OTC switches,
however, can result in enduring brands that live
into perpetuity.
References
1. Value of OTC Medicines to the US Healthcare System.
[White paper.] March 2019. Consumer Healthcare
Products Association (CHPA) and Information
resources Inc. (IRI). https://www.iriworldwide.com/
IRI/media/Library/Publications/CHPA_IRI_OTC-
Value_WhitePaper.pdf. Accessed 24 June 2021.
2. Over-the-Counter Drugs Could Save $4.75 Billion
Annually. [CHPA Study.] 1 November 2004.
Northwestern University. https://www.northwestern.
edu/newscenter/stories/2004/11/upper.html. Accessed
24 June 2021.
3. Life in Rural America. Part II. [Report.] May 2019.
Based on a survey conducted for NPR, the Robert
Wood Johnson Foundation, and the Harvard TH
Chan School of Public Health. https://media.npr.org/
documents/2019/may/NPR-RWJF-HARVARD_
Rural_Poll_Part_2.pdf. Accessed 24 June 2021.
4. EvaluatePharma World Preview 2019. Outlook to
2024. 12th Edition. June 2019. https://info.evaluate.
com/rs/607-YGS-364/images/EvaluatePharma_
World_Preview_2019.pdf?mkt_tok=eyJpIjoiWlRG-
bE1qVmpNV1kxTVRSayIsInQiOiIxb0JwRkE2V-
EdTTHhDR1VGVitnbUUyXC9pTUtRZGVa-
QTlGV0sxWDFHTzBnMklyeU9cLzcrRTd-
cL3MxTE5Qeml6OUNjQTZlTThOV1Eza-
0VpdVZzUFFjNTlpRk9oMG1menlCY0poSmI0a
DRNY2hyS0orcmk3RjhqSjQrYzlha1BHbkdZTyJ9.
Accessed 24 June 2021.
5. Symphony IRI Latest 52 Week MULO sales for the
period ending 12 July 2020.
6. The Nielsen Company—total US all outlets (food, drug,
mass, select club and dollar store retailers, convenience,
and military stores).
7. The Year 2040: Double The Pollen, Double The Allergy
Suffering? [Study.] Annual Scientific Meeting of the
American College of Allergy, Asthma and Immunology
(ACAAI). https://acaai.org/news/year-2040-dou-
ble-pollen-double-allergy-suffering. Accessed 24 June
2021.
8. Perrigo Expands OTC Growth Strategy With Rx-To-
OTC Switch Licensing For Nasonex. 9 August 2018.
Perrigo website. https://investor.perrigo.com/2018-08-
09-Perrigo-Expands-OTC-Growth-Strategy-With-
Rx-To-OTC-Switch-Licensing-For-Nasonex-R.
Accessed 24 June 2021.
9. Merck: Respiratory Medicine Running out of Breath.
[Press Release.] 26 June 2013. https://seekingalpha.
com/article/1521632-merck-respiratory-medicine-run-
ning-out-of-breath. Accessed 24 June 2021.
10. Abbreviated New Drug Application (ANDA):
091161. Company: Apotex Inc. FDA website. https://
www.accessdata.fda.gov/scripts/cder/daf/index.
cfm?event=overview.process&ApplNo=091161.
Accessed 24 June 2021.
11. Smoking Cessation: Fast Facts. Centers for Disease
Control and Prevention (CDC) website. https://www.
cdc.gov/tobacco/data_statistics/fact_sheets/cessation/
smoking-cessation-fast-facts/index.html. Accessed 24
June 2021.
12. Current Cigarette Smoking Among Adults in the
United States. CDC website. https://www.cdc.gov/
tobacco/data_statistics/fact_sheets/adult_data/cig_
smoking/index.htm. Accessed 6 July 2021.
13. Op cit 6.
14. North America Overactive Bladder Treatment Market
Research Report. Segmented by Treatment, by Disease
and by Country (US, Canada, and Rest of North
America), Industry Analysis, Size, Share, Growth,
Trends, and Forecasts (2021 to 2026). February
2020. Market Data Forecast website. https://www.
marketdataforecast.com/market-reports/na-overac-
tive-bladder-treatment-market. Accessed 24 June 2021.
15. Johnsen M. FDA makes unprecedented Rx-to-OTC
switches. Drug Store News. 10 March 2014. https://
drugstorenews.com/otc/fda-makes-unprecedented-rx-
otc-switches. Accessed 24 June 2021.
16. FDA unsure whether Merck’s patch for bladder control,
Oxytrol, ready for OTC. Posted 8 November 2012.
Updated 20 March 2019. Bloomberg News. https://
www.nj.com/business/2012/11/fda_says_mercks_
patch_for_blad.html. Accessed 24 June 2021.
17. Data courtesy Symphony IRI.
18. Cohn JA. An update on the use of transdermal
oxybutynin in the management of overactive blad-
der disorder. Therapeutic Advances in Urology. 19
January 2016. https://journals.sagepub.com/doi/
full/10.1177/1756287215626312. Accessed 24 June
2021.
19. Kewn A. Pfizer Pulls Plug on OTC Lipitor After Trial
Failure. BioSpace.com. 29 July 2015. https://www.
biospace.com/article/pfizer-pulls-plug-on-otc-lipitor-
after-trial-failure-/. Accessed 24 June 2021.
20. High Cholesterol Facts. CDC website. https://www.
cdc.gov/cholesterol/facts.htm. Accessed 24 June 2021.
21. Zocor heart-pro (discontinued in the UK—September
2010). 14 June 2012. NewDoctor website. https://www.
netdoctor.co.uk/medicines/heart-blood/a8596/zocor-
heart-pro-discontinued-in-the-uk-september-2010.
Accessed 24 June 2021.
22. Ferrini MG. Aging related erectile dysfunction—poten-
tial mechanism to halt or delay its onset. Transl Androl
Urol. 2017 Feb 6(1): 20–27. https://www.ncbi.nlm.nih.
gov/pmc/articles/PMC5313305/. Accessed 6 July 2021.
28
Long-term Rx-to-OTC switch success requires
the ability to innovate and generate “new news”
to maintain awareness, generate trial and drive
brand loyalty. Successful Rx-to-OTC switches,
however, can result in enduring brands that live
into perpetuity.
References
1. Value of OTC Medicines to the US Healthcare System.
[White paper.] March 2019. Consumer Healthcare
Products Association (CHPA) and Information
resources Inc. (IRI). https://www.iriworldwide.com/
IRI/media/Library/Publications/CHPA_IRI_OTC-
Value_WhitePaper.pdf. Accessed 24 June 2021.
2. Over-the-Counter Drugs Could Save $4.75 Billion
Annually. [CHPA Study.] 1 November 2004.
Northwestern University. https://www.northwestern.
edu/newscenter/stories/2004/11/upper.html. Accessed
24 June 2021.
3. Life in Rural America. Part II. [Report.] May 2019.
Based on a survey conducted for NPR, the Robert
Wood Johnson Foundation, and the Harvard TH
Chan School of Public Health. https://media.npr.org/
documents/2019/may/NPR-RWJF-HARVARD_
Rural_Poll_Part_2.pdf. Accessed 24 June 2021.
4. EvaluatePharma World Preview 2019. Outlook to
2024. 12th Edition. June 2019. https://info.evaluate.
com/rs/607-YGS-364/images/EvaluatePharma_
World_Preview_2019.pdf?mkt_tok=eyJpIjoiWlRG-
bE1qVmpNV1kxTVRSayIsInQiOiIxb0JwRkE2V-
EdTTHhDR1VGVitnbUUyXC9pTUtRZGVa-
QTlGV0sxWDFHTzBnMklyeU9cLzcrRTd-
cL3MxTE5Qeml6OUNjQTZlTThOV1Eza-
0VpdVZzUFFjNTlpRk9oMG1menlCY0poSmI0a
DRNY2hyS0orcmk3RjhqSjQrYzlha1BHbkdZTyJ9.
Accessed 24 June 2021.
5. Symphony IRI Latest 52 Week MULO sales for the
period ending 12 July 2020.
6. The Nielsen Company—total US all outlets (food, drug,
mass, select club and dollar store retailers, convenience,
and military stores).
7. The Year 2040: Double The Pollen, Double The Allergy
Suffering? [Study.] Annual Scientific Meeting of the
American College of Allergy, Asthma and Immunology
(ACAAI). https://acaai.org/news/year-2040-dou-
ble-pollen-double-allergy-suffering. Accessed 24 June
2021.
8. Perrigo Expands OTC Growth Strategy With Rx-To-
OTC Switch Licensing For Nasonex. 9 August 2018.
Perrigo website. https://investor.perrigo.com/2018-08-
09-Perrigo-Expands-OTC-Growth-Strategy-With-
Rx-To-OTC-Switch-Licensing-For-Nasonex-R.
Accessed 24 June 2021.
9. Merck: Respiratory Medicine Running out of Breath.
[Press Release.] 26 June 2013. https://seekingalpha.
com/article/1521632-merck-respiratory-medicine-run-
ning-out-of-breath. Accessed 24 June 2021.
10. Abbreviated New Drug Application (ANDA):
091161. Company: Apotex Inc. FDA website. https://
www.accessdata.fda.gov/scripts/cder/daf/index.
cfm?event=overview.process&ApplNo=091161.
Accessed 24 June 2021.
11. Smoking Cessation: Fast Facts. Centers for Disease
Control and Prevention (CDC) website. https://www.
cdc.gov/tobacco/data_statistics/fact_sheets/cessation/
smoking-cessation-fast-facts/index.html. Accessed 24
June 2021.
12. Current Cigarette Smoking Among Adults in the
United States. CDC website. https://www.cdc.gov/
tobacco/data_statistics/fact_sheets/adult_data/cig_
smoking/index.htm. Accessed 6 July 2021.
13. Op cit 6.
14. North America Overactive Bladder Treatment Market
Research Report. Segmented by Treatment, by Disease
and by Country (US, Canada, and Rest of North
America), Industry Analysis, Size, Share, Growth,
Trends, and Forecasts (2021 to 2026). February
2020. Market Data Forecast website. https://www.
marketdataforecast.com/market-reports/na-overac-
tive-bladder-treatment-market. Accessed 24 June 2021.
15. Johnsen M. FDA makes unprecedented Rx-to-OTC
switches. Drug Store News. 10 March 2014. https://
drugstorenews.com/otc/fda-makes-unprecedented-rx-
otc-switches. Accessed 24 June 2021.
16. FDA unsure whether Merck’s patch for bladder control,
Oxytrol, ready for OTC. Posted 8 November 2012.
Updated 20 March 2019. Bloomberg News. https://
www.nj.com/business/2012/11/fda_says_mercks_
patch_for_blad.html. Accessed 24 June 2021.
17. Data courtesy Symphony IRI.
18. Cohn JA. An update on the use of transdermal
oxybutynin in the management of overactive blad-
der disorder. Therapeutic Advances in Urology. 19
January 2016. https://journals.sagepub.com/doi/
full/10.1177/1756287215626312. Accessed 24 June
2021.
19. Kewn A. Pfizer Pulls Plug on OTC Lipitor After Trial
Failure. BioSpace.com. 29 July 2015. https://www.
biospace.com/article/pfizer-pulls-plug-on-otc-lipitor-
after-trial-failure-/. Accessed 24 June 2021.
20. High Cholesterol Facts. CDC website. https://www.
cdc.gov/cholesterol/facts.htm. Accessed 24 June 2021.
21. Zocor heart-pro (discontinued in the UK—September
2010). 14 June 2012. NewDoctor website. https://www.
netdoctor.co.uk/medicines/heart-blood/a8596/zocor-
heart-pro-discontinued-in-the-uk-september-2010.
Accessed 24 June 2021.
22. Ferrini MG. Aging related erectile dysfunction—poten-
tial mechanism to halt or delay its onset. Transl Androl
Urol. 2017 Feb 6(1): 20–27. https://www.ncbi.nlm.nih.
gov/pmc/articles/PMC5313305/. Accessed 6 July 2021.