Rx to OTC Switch, Behind the Counter Drugs & Sudafed –

An Inside Look

April 2014 Presented by Esther & Eva

PHA654 Professor Donald OrloskiLIU Pharmacy

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Presentation Outline Overview Rx to OTC

Rx to OTC Switch Market by Therapeutic Categories U.S. Market for Rx to OTC Switches Potential Rx-to-OTC Switches

Focus on Sudafed Therapeutic Indication Product Line In The Media Abuse of Pseudoephedrine Behind the Counter Status Future Outlook

References

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Overview: Rx to OTC Switch 106 ingredients, indications, or dosage strengths have made

the switch from Rx to OTC status or have been newly approved since 1976. [1]

That translates to more than 700 OTC products on the market today.[1]

Pseudoephedrine hydrochloride was transferred from Rx to OTC Status on September 9, 1976 [2]

According to a study conducted by researchers at Northwestern University, using OTCs to treat only certain upper respiratory infections could save $4.75 billion annually. [1]

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Overview:Market by Therapeutic Categories

[3]

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Overview: US Market for Rx to OTC Switches

[3]

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Overview:Potential Rx to OTC Switches

Drug Patent Expiry Date

Expected Switch Year

US Patent Numbers

Crestor 17/6/2022 >2014 6858618, 6316460, 7030152, RE37314

Lipitor 8/1/2017 >2014 5969156, 4681893, 5273995, 5686104

Pravachol 22/10/2014

>2014 5622985

TriCor 21/2/2023 >2014 7276249, 5145684, 6277405, 6375986

Vytorin 25/4/2017 >2014 RE37721, 5846966

Zetia 25/7/2022 >2014 7030106, 5846966, 7612058, RE37721

Nexium 25/11/2018

>2014 7411070, 5690960, 5714504, 5877192 [4]

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Focus on: Sudafed

Allergy/Cold temporarily relieves nasal

congestion due to the common cold, hay fever or other respiratory allergies

temporarily relieves sinus congestion and pressure

reduces swelling of nasal passages [5]

Active Ingredient: pseudoephedrine

Therapeutic Indication

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Focus on Sudafed:Sudafed Product Line

Pseudocot®

Ridafed®

Silfedrine®

Sudafed 12/24 ®

Hour®

Sudafed Congestion®

Sudodrin®

Congestaclear®

Myfedrine®

SudoGest®

Sudrine®

Superfed®

Suphedrin®

Afrinol®Cenafed®

Children's Sudafed Nasal Decongestant® [6]

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Focus on Sudafed:In the Media

[7]

[8]

[9]

[10]

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Focus on Sudafed:AbuseMethamphetamine Abuse

Most of the methamphetamine abused in the United States is manufactured in “superlabs” in US or Mexico with relatively inexpensive OTC ingredients such as pseudoephedrine.

Although the trend in youth abuse of meth has decreased, for the first half of 2012, methamphetamine ranked “first in drug related treatment admissions in Hawaii and San Diego, second in San Francisco, and third in Denver and Phoenix according to NIH.”

Community Impact According to NIH, abuse of tobacco, alcohol, and illicit drugs is

costly to our Nation, exacting over $600 billion annually in costs related to crime, lost work productivity and healthcare.

[11]

[12]

[13]

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Focus on Sudafed:Behind the Counter Status Behind the Pharmacy or Service Counter

Combat Methamphetamine Epidemic Act of 2005▪ Effective September 30, 2006▪ Pseudoephedrine-containing products must be sold behind the pharmacy counter or from locked

cabinets ▪ Limits the amount an individual can purchase▪ Purchaser must present photo identification to purchase such medications▪ Retailers are required to keep personal information for 2 years after purchase in a log book

Important note: NOT A REGULATORY CATEGORY IN THE US. US officially has two regulatory categories of drugs: prescription and over-the-counter medicines at this time.

However, it is an official class for drugs in several countries including United Kingdom, Canada and Australia referred to as pharmacy (P), pharmacist only, or Schedule 3. In fact, in the UK, half the medicines available without a prescription are in this category. [15]

[14]

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Focus on Sudafed:Behind the Counter Status (cont’d)

Reformulation Efforts for OTC Cold Medicine“Sudafed contains the active ingredient Pseudoephedrine, while the active ingredient in Sudafed PE is Phenylephrine.   In response to the issue of misuse of pseudoephedrine-containing products, many companies are voluntarily re-formulating their products to exclude phenylpropanolamine, ephedrine, and pseudoephedrine.”  [16]

[17]

[6]

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Focus on Sudafed:Future OutlookReverse Switch? One of the rare moments

OTC is reversed to Rx? Reformulations are exempt…

[18]

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Questions?

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References1. http://www.chpa.org/FAQsSwitchPP.aspx 2. http://www.chpa.org/SwitchList.aspx 3. https://www.dolcera.com/wiki/index.php?title=Rx_to_OTC_Switch-Market_Analysis 4. http://

dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9991599a-b49b-4ea6-a6e1-c05f0c992f71#nlm34067-9

5. http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682619.html 6. http://www.sudafed.com/ 7. http://www.imdb.com/title/tt0903747/8. http://www.slate.com/blogs/quora/2013/10/18/what_s_a_sudafed_smurf.html 9. http://science.howstuffworks.com/meth3.htm10. http://www.chron.com/news/nation-world/article/Buying-Sudafed-Meth-cops-may-get-e-mail-

1669755.php11. http://www.drugabuse.gov/publications/drugfacts/methamphetamine12. http://www.drugabuse.gov/publications/research-reports/methamphetamine/what-scope-me

thamphetamine-abuse-in-united-states

13. http://www.drugabuse.gov/related-topics/trends-statistics#costs14. http://

dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9991599a-b49b-4ea6-a6e1-c05f0c992f71#nlm34067-9

15. https://www.nabp.net/events/assets/Branding12508NABP.pdf16. http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm072423.htm 17. http://www.cbsnews.com/news/in-fight-against-crystal-meth-a-focus-on-chemistry/18. http://www.statejournal.com/story/24745222/wv-senate-rejects-bill-to-offer-aid-to-some-stu

dents