Over-the-counter (OTC) drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, and are commonly used to treat symptoms of common illnesses that may not require the direct supervision of a physician.
There are two ways in which drugs are commonly switched as approved by FDA in US :
The FDA process for drug approval is given below
Source:FDA , Nonprescription Product Therapeutics, Section 1, Chapter 2
Once a drug has been discovered, the drug manufacturer must test the drug in laboratory and on animals. If it proves effective, the drug is tested in humans to see if it safe and effective. Once it is demonstrated to be safe, the manufacturer sends a New Drug Application (NDA) to the FDA to apply for approval. Next come tests in humans to see if the drug is safe and effective when used to treat or diagnose a disease.
New Drug Application (NDA)
The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:
The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.
NDAs include:
The FDA approves drugs if their benefits outweigh any risks in taking them. Once a drug is approved, its manufacturer can market and then sell it in the U.S. In approving the drug, the FDA also takes into account the proposed name for it. To protect the safety of the public, it is important that the name not be similar to that of another drug product to prevent against mix-ups. FDA's Division of Medication Error Prevention and Analysis reviews the names.
Source:FDA,Pharmacy.About
Generic drugs are also known as copycat drugs. They are exact replicas of the branded drugs and typically go by their chemical name-Lipitor's generic is called atorvastatin, for example. They do not have a patent. The manufacturers of generic drugs provide an abbreviated new drug application (ANDA) to the FDA to receive approval. Since there is already a drug on the market to help consumers, the approval time for generic drugs is typically longer. The Office of Generic Drugs (OGD), which is a department within the FDA, approves generic drugs.
An Abbreviated New Drug Application (ANDA) is submitted to the FDA when seeking review and approval for a generic drug product. The application is submitted to the FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. If approved, the generic drug may be manufactured and sold in the U.S. market.
Generic drug applications are not typically required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. An applicant submitting an ANDA must scientifically demonstrate that its product is bioequivalent to the previously approved innovator or brand name drug.
Source:Pharmacy.about1, Pharmacy.about2
FDA requires generic drugs to have the same quality and performance as brand name drugs.
Source: FDA
The FDA's Office of Drug Evaluation IV, Over-the-Counter Drug Products reviews OTC drugs. A Nonprescription Drug Advisory Committee, comprised of up to 14 independent experts selected by the FDA commissioner, assists the FDA in reviewing issues surrounding OTC drugs, including switching drugs from prescription to non-prescription status.
Instead of reviewing the labels and ingredients of all 300,000 OTC drugs now being marketed, the FDA focuses on about 80 different therapeutic classes of drugs, such as analgesics, antacids, antimicrobial, antiperspirants, dental and cough/cold medicines.
The FDA publishes an OTC drug monograph for each category of drug in the Federal Register. Drug monographs serve as a cook book, or list of recipes, that include acceptable ingredients, formulations, dosages and labeling for each category of drug.The monograph explains the types of ingredients that may be used to treat certain diseases or conditions without a prescription, the appropriate dose and instructions for use, and labeling.
Once a monograph is adopted, companies may develop and market an OTC product without pre-approval from the FDA. Products that do not adhere to the monograph must be reviewed through FDA?s New Drug Application process.A drug company can also petition the FDA to deviate from the ingredient or labeling requirements of an OTC monograph.
Source:Pharmacy.About1,Pharmacy.About2
There are 2 regulatory pathways for getting approval for OTC drugs (Rx to OTC switch and Direct to OTC) „
Rx-to-OTC switches
„The applications differ based on whether the manufacturer wants to switch to OTC completely or partially.
Source:FDA
Direct-to-OTC
Source:OTC Regulation in Different Countries
FDA Applications
OTC drug review
The OTC drug review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972. It is a three-phase public rulemaking process (each phase requiring a Federal Register publication) resulting in the establishment of standards (monographs or non-monographs) for an OTC therapeutic drug category.
Clinical trials are not a compulsory requirement for Rx-to-OTC switches, but most switch applications include new clinical trial data for the non-prescription indication and almost all the switch applications include label comprehension studies and/or actual use studies to demonstrate that the medicine can be used safely and effectively in the consumer target population. Additional standard efficacy and safety clinical trials are to prove the drug can be used safely in an OTC setting.
FDA?s Center for Drug Evaluation and Research (CDER) defines OTC drug actual use study as ?a controlled experiment in which a prescription drug or unapproved new drug is used by subjects under OTC-like conditions.? OTC studies are intended to support a significant change in labelling for the drug. These studies are considered the most important in assessing a drug?s appropriateness for a switch. The main Objectives of an Rx-to OTC study fall into four main categories:
If the drug has a good safety profile, shown by the studies done to support its marketing as a prescription drug, and if the drug meets the specific criteria for switching which includes ability of selection or de-selection by consumer, there is relatively good chance that FDA will approve it for OTC use.
Source:FDA, Compliance Online
Time Period | CAGR |
2005-2009 | 3.3% |
2009-2014 | 2.7% |
2005-2014 | 3.0% |
Total Pharmaceutical Market by Country, 2009 ($B)
Country | Rx Market | OTC Market | Total Pharma Market | OTC as % of Total Pharma Market |
United States | 214 | 18 | 232 | 7.8 |
Japan | 56 | 11 | 67 | 16.4 |
Germany | 35 | 5 | 40 | 12.5 |
France | 32 | 4 | 36 | 11.1 |
China | 16 | 5 | 21 | 23.1 |
United Kingdom | 17 | 3 | 20 | 15.0 |
Russia | 13 | 3 | 16 | 18.8 |
Brazil | 10 | 2 | 12 | 16.7 |
Mexico | 9 | 2 | 11 | 18.1 |
India | 6 | 3 | 9 | 33.3 |
Source: Kalorama Information
S.No | Switched Drug | Manufacturer/Marketer | Drug Category | Switch Year | First 12-Month Sales (in $M) |
1 | Alli | Glaxo SmithKline Consumer Healthcare | Weight Loss Aid | 2007 | 80 |
2 | MiraLax | Schering-Plough Healthcare | Gastrointestinal | 2006 | 40 |
3 | Prilosec OTC | Procter & Gamble | Gastrointestinal | 2003 | 130 |
4 | Claritin | Schering-Plough Healthcare | Allergy | 2002 | 380 |
5 | Nicoderm CQ | Glaxo SmithKline Consumer Healthcare | Smoking Cessation | 1996 | 160 |
6 | Nicorette | Glaxo SmithKline Consumer Healthcare | Smoking Cessation | 1996 | 195 |
7 | Rogaine | McNeil Consumer Healthcare | Hair Loss | 1996 | 180 |
8 | Pepcid AC | Johnson & Johnson- Merck Consumer Pharmaceuticals Co. | Gastrointestinal | 1995 | 200 |
9 | Zantac 75 | Boehringer Ingelheim Consumer Healthcare Products | Gastrointestinal | 1995 | 140 |
10 | Aleve | Bayer Consumer Care | Analgesic | 1994 | 110 |
Source:Company Websites, Press Releases and Journals
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 |
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 | -- | 4874794 |
2 | Pepcid Complete | J&J/Merck | 17/10/2000 | 15/10/2000 | -- | 4283408 |
3 | Mucinex | Adams Respiratory Therapeutics | 12/7/2002 | 28/04/2020 | -- | 6372252 |
4 | Commit | GlaxoSmithKline | 31/10/2002 | 21/08/2010 | -- | 5110605 |
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 | -- | 4282233 |
7 | Anthelios SX | L?Oreal | 21/07/2006 | 24/12/2013 | -- | 5587150 |
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 |
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 |
The research instrument used was a questionnaire survey administered to collect empirical data. The physician responses were kept confidential to encourage openness and disclosure. The respondents rated the questions on Yes or No, ticked the relevant choices from the options available and ranked the options on a numerical scale. All the responses were coded using a binary system logic and analysis was done to derive insights there after.
Gender | Sample Size |
Male | 18 |
Female | 2 |
Total Physicians | 20 |
Screening Criteria | |
Primary Medical Specialty | General Physician/Family Practice |
No. of years in practice | 10 |
No. of patients consulting per month | 150 |
The effective ranking of the ailments in the order of safety of available OTC drugs is as follows:
To see the calculation of the effective scores and effective ranking, click on this link
The reason for carrying out this research is to determine the scope of potential switch of prescription drugs to over the counter drugs in the Indian pharma industry. The study is particularly focused at the scope of making statins(a drug for reducing cholesterol level) available over-the-counter. The study aims to understand how successful a switch would be, and if it is safe for such drugs to be made available without prescription. The study also aims at determining the marketing pattern of over the counter drugs, and how it can be improved in future.
The objectives for the survey are :
The research instrument used was a questionnaire survey administered to collect empirical data. The physician responses were kept confidential to encourage openness and disclosure. The respondents rated the questions on Yes or No, ticked the relevant choices from the options available and ranked the options on a numerical scale. All the responses were coded using a binary system logic and analysis was done to derive insights there after.
Screening Criteria
Screening Criteria | |
Medical Specialty | General Physician, Consulting Physician, Gynaecologist, Dermatologist, Cardiologist, Pediatrician |
No. of years in practice | 10 |
No. of patients consulting per month | 150 |
Sample Size
Gender | Sample Size |
Male | 44 |
Female | 16 |
Total Physicians | 60 |
Medical Specialty-wise Breakup | |
General Physician | 17 |
Consulting Physician | 9 |
Gynecologist | 9 |
Dermatologist | 4 |
Cardiologist | 12 |
Pediatrician | 6 |
Geographywise Breakup | |
Mumbai | 15 |
Hyderabad | 15 |
Delhi NCR | 14 |
Bangalore | 16 |
The effective ranking of the ailments in the order of safety of available OTC drugs is as follows:
To see the calculation of the effective scores and effective ranking, click on this link
Effectiveness of marketing campaigns
Results on Statins