Summary
For a medicine to be granted OTC status, it must have a wide safety margin and be effective, and must bear understandable labeling to ensure proper use. More than 700 OTC products on the market today use ingredients or dosages available only by prescription less than 30 years ago. Rx-to-OTC switch refers to the transfer of proven prescription drugs (Rx) to non-prescription, over-the-counter (OTC) status. Rx-to-OTC switch is a data-driven, scientifically rigorous, and highly regulated process that allows consumers to have OTC access to a growing range of medicines
The compound annual growth rate (CAGR) of OTC market from 2005-2009 was 3.3%. The CAGR from 2009-2014 is expected to be 2.7%.
There are two ways in which drugs are commonly switched as approved by FDA in US:
S.No | Switched Drug | Manufacturer/Marketer | Drug Category | Switch Year | First 12-Month Sales (in millions) |
1 | Aleve | Bayer Consumer Care | Analgesic | 1994 | $110 |
2 | Alli | GlaxoSmithKline Consumer Healthcare | Weight Loss Aid | 2007 | $80 |
3 | Claritin | Schering-Plough Healthcare | Allergy | 2002 | $380 |
4 | MiraLax | Schering-Plough Healthcare | Gastrointestinal | 2006 | $40 |
5 | Nicoderm CQ | GlaxoSmithKline Consumer Healthcare | Smoking Cessation | 1996 | $160 |
6 | Nicorette | GlaxoSmithKline Consumer Healthcare | Smoking Cessation | 1996 | $195 |
7 | Pepcid AC | Johnson & Johnson - Merck Consumer Pharmaceuticals Co. | Gastrointestinal | 1995 | $200 |
8 | Prilosec OTC | Procter & Gamble | Gastrointestinal | 2003 | $130 |
9 | Rogaine | McNeil Consumer Healthcare | Hair Loss | 1996 | $180 |
10 | Zantac 75 | Boehringer Ingelheim Consumer Healthcare Products | Gastrointestinal | 1995 | $140 |
Consumers: In the current scenario, consumers are looking to cut their health care costs
Government: US government is proactively finding ways to make health care more affordable
Companies: Companies are constantly evaluating various options to keep the consumer product segments profitable
S.NO. | INGREDIENT | PRODUCT CATEGORY | DATE OF OTC APPROVAL | PRODUCT EXAMPLES | COMPANY |
1 | ibuprofen (NDA)** | migraine | 25/02/2000 | Motrin Migraine Pain | McNeil Consumer Healthcare |
2 | docosanol (NDA)* | cold sore/fever blister | 25/07/2000 | Abreva Cream | Avanir Pharmaceuticals |
3 | famotidine, calcium carbonate, | heartburn, | 17/10/2000 | Pepcid Complete | J&J/Merck |
magnesium hydroxide (NDA)* | acid indigestion | ||||
4 | butenafine hydrochloride (NDA) | athlete?s foot, jock itch, ringworm | 7/12/2001 | Lotrimin Ultra | Schering-Plough |
5 | ibuprofen, pseudoephedrine HCl, | analgesic/decongestant | 18/04/2002 | Children?s Advil Cold | Wyeth |
suspension for pediatric use (NDA)* | |||||
6 | guaifenesin extended-release tablet (NDA) | expectorant | 12/7/2002 | Mucinex | Adams Respiratory Therapeutics |
7 | nicotine polacrilex troche/lozenge (NDA)* | smoking cessation | 31/10/2002 | Commit | GlaxoSmithKline |
8 | loratadine (NDA) | antihistamine | 27/11/2002 | Claritin Tablets, Claritin RediTabs, Claritin Syrup | Schering-Plough |
9 | loratadine, pseudoephededrine sulfate (NDA) | antihistamine/ | 27/11/2002 | Claritin-D 12 Hour Extended Release Tablets, | Schering-Plough |
decongestant | |||||
10 | omeprazole magnesium | acid reducer to treat frequent heartburn | 20/06/2003 | Prilosec OTC | Procter & Gamble |
11 | loratadine (NDA)** | hives relief | 15/11/2003 | Claritin hives relief | Schering-Plough |
diphenhydramine citrate & ibuprofen (NDA)*; diphenhydramine HCl & ibuprofen potassium (NDA)* | analgesic sleep-aid | 21/12/2005 | Advil PM | Wyeth | |
12 | ecamsule (combined with avobenzone and octocrylene (NDA)* | sunscreen | 21/07/2006 | Anthelios SX | L?Oreal |
13 | levonorgestrel (NDA) | contraceptive | 24/08/2006 | Plan B | Duramed |
polyethylene glycol 3350 (NDA) | laxative | 6/10/2006 | MiraLAX | Schering-Plough | |
14 | ketotifen (NDA) | antihistamine eye drops | 19/10/2006 | Zaditor | Novartis |
15 | orlistat (NDA) | weight loss aid | 7/2/2007 | alli | GlaxoSmithKline |
cetirizine HCl & pseudoephedrine HCl (NDA) | antihistamine/ | 9/11/2007 | Zyrtec-D | McNeil | |
16 | decongestant | ||||
17 | cetirizine HCl (NDA) | antihistamine, hives relief | 16/11/2007 | Zyrtec | McNeil |
lansoprazole (NDA) | acid reducer to treat | 18/05/2009 | Prevacid 24 HR | Novartis | |
18 | frequent heartburn | ||||
19 | levonorgestrel (NDA) | contraceptive | 10/7/2009 | Plan B One Step | Duramed |
omeprazole and sodium | acid reducer to treat | 1/12/2009 | Zegerid OTC | Schering-Plough | |
20 | bicarbonate (NDA) | frequent heartburn |
Blue highlighted drugs are patent-protected
Purple highlighted drugs are under FDA exclusivity period
S.NO. | PRODUCT EXAMPLES | COMPANY | DATE OF OTC APPROVAL | PATENT EXPIRY | FDA EXCLUSIVITY | PATENT NUMBER |
1 | Abreva Cream | Avanir Pharmaceuticals | 25/07/2000 | 28/04/2014 | -- | 4,874,794 |
2 | Pepcid Complete | J&J/Merck | 17/10/2000 | 15/10/2000 | -- | 4,283,408 |
3 | Mucinex | Adams Respiratory Therapeutics | 12/7/2002 | 28/04/2020 | -- | 6,372,252 |
4 | Commit | GlaxoSmithKline | 31/10/2002 | 21/08/2010 | -- | 5,110,605 |
5 | Prilosec OTC | Procter & Gamble | 20/06/2003 | 15/11/2019 | -- | 5690960, 5753265, 5817338, 5900424, 6403616, 6428810 |
6 | Claritin hives relief | Schering-Plough | 15/11/2003 | 19/06/2002 | -- | 4,282,233 |
7 | Anthelios SX | L?Oreal | 21/07/2006 | 24/12/2013 | -- | 5,587,150 |
8 | Plan B | Duramed | 24/08/2006 | -- | 24/08/2009 | -- |
9 | MiraLAX | Schering-Plough | 6/10/2006 | -- | 6/10/2009 | -- |
10 | alli | GlaxoSmithKline | 7/2/2007 | 6/1/2018 | 7/2/2010 | 6004996 |
11 | Zyrtec-D | McNeil | 9/11/2007 | 10/6/2022 | -- | 6469009, 6489329, 7014867, 7226614 |
12 | Zyrtec | McNeil | 16/11/2007 | 2/7/2018 | -- | 6455533 |
13 | Prevacid 24 HR | Novartis | 18/05/2009 | -- | 18/05/2012 | -- |
14 | Plan B One Step | Duramed | 10/7/2009 | -- | 10/7/2012 | -- |
15 | Zegerid OTC | Schering-Plough | 1/12/2009 | 15/07/2016 | -- | 6489346, 6645988, 6699885, 7399772 |
Blue highlighted drugs are patent-protected
Purple highlighted drugs are under FDA exclusivity period
S.NO | DRUG | PATENT EXPIRY DATE | EXPECTED SWITCH YEAR | US PATENT NUMBERS |
1 | Allegra | 14/3/2017 | 2012 | 5578610, 6037353, 6187791, 6399632, 7138524 |
2 | Clarinex | 1/12/2018 | >2013 | 6514520, 7211582, 7214683, 7214684 |
3 | Crestor | 17/6/2022 | >2014 | 6858618, 6316460, 7030152, RE37314 |
4 | Lescol | 12/6/2012 | >2014 | 5356896, 5354772, |
5 | Lipitor | 8/1/2017 | >2014 | 5969156, 4681893, 5273995, 5686104, 5969156, 6126971, RE40667 |
6 | Pravachol | 22/10/2014 | >2014 | 5622985 |
7 | TriCor | 21/2/2023 | >2014 | 7276249, 5145684, 6277405, 6375986 , 6652881, 7037529, 7041319, 7320802 |
8 | Vytorin | 25/4/2017 | >2014 | RE37721, 5846966, |
9 | Zetia | 25/7/2022 | >2014 | 7030106, 5846966, 7612058, RE37721 |
10 | AcipHex | 8/5/2013 | 2013 | 5045552 |
11 | Nexium | 25/11/2018 | >2014 | 7411070, 5690960, 5714504, 5877192, 5900424, 6147103, 6166213, 6191148, 6369085, 6428810, 6875872 |
12 | Protonix | 30/3/2025 | 2010 | 7553498, 4758579, 7544370, 7550153 |
13 | Zofran | 7/12/2026 | >2014 | 7544370, 4758579, 7550153, 7553498 |
14 | Propecia | 5/11/2013 | 2011 | 5571817, 5547957, 5886184 |
15 | Imitrex | 10/3/2014 | >2010 | 5554639, 5307953, 5705520 |
16 | Actonel | 10/12/2018 | >2014 | 6165513, 5583122, 6096342 |
17 | Boniva | 2/9/2014 | >2014 | 5662918, 4927814 |
18 | Fosamax | 17/1/2019 | >2014 | 6225294, 5462932, 5994329, 6015801 |
19 | Evista | 10/3/2017 | >2014 | 6894064, 6797719, 6458811, 5393763, 5457117, 5478847, 5811120, 5972383, 6906086, RE38968, RE39049, RE39050 |
20 | Detrol | 11/5/2020 | >2014 | 5382600, 6630162, 6770295, 6911217 |
21 | Ditropan | 22/11/2015 | >2014 | 5674895, 5840754, 1 5912268, 6262115, 6919092 |
22 | Cialis | 26/4/2020 | >2014 | 7182958, 5859006, 6140329, 6821975, 6943166 |
23 | Levitra | 31/10/2018 | >2014 | 6362178, 7696206 |
24 | Viagra | 22/10/2019 | >2014 | 6469012, 5250534 |
Objectives of the survey
Sample size of physicians | 20 |
Primary medical specialty | General or Family Practice |
Avg of visiting patients per month | 466 patients |
Avg of years of experience | 20 years |
Physician panel provisioned by: World One.
About 50% of the respondents think that more OTC drugs should be included under Medicare/insurance coverage.
About 85% of the respondents think that the information on the labels of OTC drugs is sufficient.
About 45% of respondents think that the problem of non-prescription medicine today is somewhat serious.
Only 30% of respondents replied in positive when asked about permitting marketing executives to market OTC products through them.
100% of the respondents feel it is important to prescribe a drug that minimizes patients' out-of-pocket costs, while choosing between equally effective and safe medications.
Physicians perceive OTC drugs to be: