Analyzing Prescription & OTC Patents – Latest Pharmaceuticals Patent Examples (2024)
When it comes to patenting in the US, pharmaceuticals are still running strong. In fact, during the first quarter of 2019, there were 9 million patent applications filed at the US Patent and Trademark Office (USPTO). The United States Patent and Trademark Office (USPTO) receives approximately 500,000 new patent applications every year, with about 80% coming from individuals or small businesses.
The pharmaceutical industry is among the largest patent filers in the US and thus we have compiled a list of the latest patents and patenting trends on Pharmaceuticals in the US.
Prescription & OTC Drugs in the US
Innovation and patents in Prescription & OTC drugs have come a long way since the creation of penicillin. New drugs now treat disease, improve quality of life and prolong life for millions of people every year.
While new medicines are always being discovered, finding the right prescription or OTC (over-the-counter) drug can be a challenge. The use of drugs has been steeped in controversy for many years.
The risks of taking drugs are well-known and documented i.e., the overdose can be harmful and also the OTC painkillers are a major problem in the US, because people commonly misuse them but that is not stopping people from using them.
They can cause extreme damage and harm on your body in almost every way possible. People don’t understand how dangerous these drugs can be, but they should know because they can die from them by their own hands.
The Food and Drug Administration (FDA) has the authority to regulate drugs and other products, including medical devices and human cells, tissues, and cellular and tissue-based products.
The agency may refuse to approve a product or device if it doesn’t meet safety requirements for approval, which includes a drug’s effectiveness, quality, and safety data. It also issues new rules covering new technologies in its “good manufacturing practice” rules.
OTC Pharmaceutical Trend 2023
If you’re interested in learning about OTC pharmaceutical trends, you’ve come to the right place! The OTC drugs market is a hot topic these days as consumers are seeking more and more non-prescription medicines. In fact, there is a particular trend in the market that is increasing the demand for over-the-counter (OTC) drugs and is projected to be worth over $10 billion in 2023.
COVID-19 pandemic accelerates consumer inclination toward non-prescription drugs
The COVID-19 pandemic tested the limits of America’s health systems. It also accelerated the consumer inclination towards the non-prescription drugs vs. prescription drugs debate, which will continue to rumble on. Some states will have to revisit their tax strategies to accommodate the new reality. This will likely be a boon to industry players in the region.
The COVID-19 ain’t quite as bad as it once was. But with the exception of some key therapy areas, it is no longer a disease of national proportions. So what can the industry expect from the next decade? In the next five years, the APAC OTC drugs market is slated to reach USD 108 billion. By 2032, the corresponding figure is expected to increase by another USD 30 billion. And in order to meet these rising demands, the industry will need to step up its game.
One thing that sparked some interest was the fact that the OTC drugs market was expected to exhibit a 5% CAGR over the next 5 years. While the number of prescriptions is expected to remain relatively constant, the growing prevalence of non-prescription drugs will positively impact the APAC industry. As an additional bonus, the market has the opportunity to capitalize on some of the most exciting innovations gracing the healthcare scene, such as telehealth and digitally-managed medicine. Moreover, the burgeoning Indian healthcare sector has made the country a pillar of the global pharmaceutical industry.
Although the OTC drugs market is not expected to be in the same league as the pharma industry in the near future, it is still on a roll. This is mainly attributed to the fact that India is recognized as a hub for the world’s largest pharmacy sector. Furthermore, the government is actively pursuing its plans to expand and modernize the healthcare infrastructure. To support this endeavour, the government is investing in the infrastructure by funding a series of high-profile medical re
search projects. These efforts, in particular, are boosting the visibility of the OTC drugs industry in the region. Considering the above-mentioned fact, it is no surprise that the market is expected to make an important contribution to the national health budget in the coming decades.
Increasing incidences of chronic ailments are accelerating the OTC drugs market
The OTC drugs market is a competitive arena where several companies compete for the top position. Key players in the market include GlaxoSmithKline PLC, Reckitt Benckiser Group Plc., and Teva Pharmaceutical Industries Ltd.
Several factors are driving growth in the OTC drugs market. One such factor is the rising prevalence of chronic ailments. Another factor is the increasing preference for self-medication. In addition, the availability of over-the-counter (OTC) medicines at reasonable costs is also expected to drive growth in the market.
Furthermore, the increased awareness of chronic illnesses and the emergence of novel infectious diseases have fueled consumer interest in daily supplements. Additionally, the growth of the middle class is expected to increase disposable income. This in turn, will increase the number of people who require medication.
Despite the growth of the OTC market, the industry faces several challenges. For instance, there are still many necessary medicines that are not available in the market. Also, the probability of substance abuse restrains the industry’s growth.
However, the market is slated to witness significant growth in the coming years. Moreover, the increasing prevalence of chronic diseases is likely to drive the OTC analgesics market. Moreover, the introduction of new products and their approval by the FDA is expected to propel the segment’s growth.
On the other hand, the growing population and the growing middle class in the Asia Pacific region is expected to propel the growth of the OTC drugs market. Likewise, the emergence of countries such as India and Japan as potential medical tourism destinations is expected to enhance the demand for OTC drugs.
Moreover, the COVID-19 pandemic has affected the healthcare industry and is expected to provide an impetus for R&D expenditure. Consequently, the OTC industry is undergoing a rapid transformation.
The market is anticipated to grow at a CAGR of 5.8% from 2021 to 2028. Although the market is currently dominated by a few major players, several mid-size and smaller companies are poised to make their presence felt in the OTC drugs market. These players are expected to introduce new products with a decreased price tag.
Drug abuse is a big concern for OTC drugs
The latest edition of the National Survey on Drug Abuse and Health reports that prescription drug abuse is on the rise. While you might think that teenagers are the only people who get addicted to medicines prescribed to them, the truth is that many adults are abusing prescription medications. Thankfully, there are options for getting clean. Some of the best drug rehab programs in the nation offer round-the-clock medical care and a variety of treatment modalities to suit the needs of all patients. This includes outpatient programs for those who prefer the comforts of home.
OTC drugs can be addictive, but they’re not nearly as dangerous as their illicit counterparts. In fact, some of the drugs on the market today are lauded for their safety. For example, anti-diarrheal medication like ibuprofen is one of the safest pain relievers around. As a result, many consumers have become more tolerant of these medicines. Although they may not be as deadly as their illicit cousins, they can also cause other mishaps like high blood pressure, depression, and weight gain.
To be clear, the best and most effective way to overcome an OTC drug addiction is to enlist the help of a professional. Many people have a hard time recognizing when their OTC drug use has gotten out of control. They are often unprepared for the onset of withdrawal symptoms. A trained professional can give them the information they need to kick their habit for good. If you are concerned that your loved one might be suffering from an OTC drug addiction, consult a doctor. You can’t save them from themselves, but you can make their life a little easier. There is a wide range of options available, so be sure to talk with your health care provider about your loved one’s needs. Your support can go a long way in helping them achieve recovery.
Increasing awareness of OTC drugs
In recent years, consumers have started using over-the-counter (OTC) drugs as a first-line treatment for minor illnesses. Over-the-counter medicines include products like cough, cold, and flu medications, as well as expectorants, laxatives, and decongestants. They are available at low costs and are safe to use without a doctor’s prescription.
However, increased access to over-the-counter drugs can be harmful, especially in developing countries. Lack of knowledge about how to use OTC drugs can lead to adverse health effects. Therefore, the need for greater public awareness on the risks of self-medication with OTC medicines is necessary.
The market for OTC medicines is growing in Latin America, Asia-Pacific, and Southeast Asia. Growth is expected to be high in emerging markets because of the increasing population and the growing middle class. Moreover, product innovations and a favorable regulatory framework are key factors driving growth.
The over-the-counter drugs market is highly competitive. There are several key players in the industry including Johnson and Johnson, GlaxoSmithkline PLC, and Hisamitsu Pharmaceutical Co. Inc. These companies hold significant market shares. Nevertheless, mid-size and smaller companies are also increasing their presence in the industry. New product launches and fewer prices are helping them to attract new customers.
Recent studies have looked at the level of awareness about OTC drugs. Most patients do not understand the risks of consuming non-pharmaceutical OTC medicines. Some may be unaware of the dangers of buying drugs from a non-pharmacy outlet, while others think that a pharmacist consultation is unnecessary.
As a result, the study suggests that better communication between pharmacists and patients could improve their confidence in using OTC medicines. Patients may be concerned about using medicinal products simultaneously, although the study did not address this question.
According to the study, the number of patients who consult with a physician about OTC drugs is declining. Furthermore, the study found that a large part of the population is not comfortable going to the hospital for a minor illness.
Patients were also asked to comment on proposed solutions to reduce the risks of using non-pharmacological OTC medicines. One respondent stated that he would prefer the distribution of OTC drugs in a community pharmacy.
Needs in Prescription & OTC Drugs Innovation and Patenting
The patents for pharma companies are extremely useful in the US. This is why many of the companies can make lots of money, because they have the exclusive rights to sell their products. The US is a highly competitive marketplace when it comes to pharmaceuticals. Knowledge of intellectual property rights and patents is a great asset for anyone in the pharmaceutical business.
Health is critical to an individual’s survival and quality of life. It includes physical, mental, emotional, and social well-being. Public health plays an important role in ensuring a healthy community.
The Pharmaceuticals industry in the US is one of the primary manufacturers of both generic and branded pharmaceutical products. This sector has seen considerable growth in recent years, driven by a growing demand for medical treatments and the massive marketing campaigns designed to show patients that the latest drugs will bring them superior results compared to older alternatives.
Hence, the prescription & OTC drugs patents in the US creates value by preventing drug companies from being cheated out of their hard-earned money. If a drug company has spent years researching and creating a cure for cancer, they should be able to monetize their product. Without these patents the company would get no return on investment and innovation would cease to grow in the sector.
OTC Drug Patenting Planning
Over-the-counter (OTC) drugs, also known as non-prescription drugs, can be eligible for patent protection, just like any other pharmaceutical product. However, the process and the requirements for obtaining a patent on an OTC drug may be different from those for prescription drugs.
To be eligible for a patent, an OTC drug must meet the same requirements as any other pharmaceutical product, including novelty, non-obviousness, and usefulness. In addition, the patent application must describe the invention in enough detail to enable a person skilled in the art to make and use the invention.
OTC drugs are not subject to the same regulatory approval process as prescription drugs, so the patent application may not include detailed information about clinical trials or safety and efficacy data. Instead, the patent application may focus on the composition of the drug, its method of use, and any new and useful properties or advantages that it offers over existing products.
It’s important to note that, even if a patent is granted for an OTC drug, it doesn’t mean that the drug is safe and effective. Safety and efficacy of OTC drugs are determined by regulatory bodies such as the FDA. A patent just protects the invention from being copied by others without permission.
In summary, OTC drugs can file for patent protection, but the process and requirements for obtaining a patent may be different than those for prescription drugs, and a patent does not guarantee that the drug is safe and effective. It’s important to consult with a patent attorney or agent who has experience in the pharmaceutical field and understands the complexities of patenting OTC drugs, to help navigate these considerations and to ensure that the company’s patent application(s) are as strong as possible.
When filing for a patent on an over-the-counter (OTC) drug, there are several important considerations to keep in mind:
- Novelty and non-obviousness: The drug must be novel and non-obvious in order to be patentable. This means that the invention cannot be obvious to a person having ordinary skill in the field and it must not be described in prior art.
- Composition of matter: The patent application should include the full chemical composition of the drug, including any new and non-obvious compounds, formulations, or method of production.
- Method of use: The patent application should describe the method of use for the drug, including any new and non-obvious dosage forms, administration routes, or regimens.
- Safety and efficacy: The patent application may not include detailed information about clinical trials or safety and efficacy data, as OTC drugs are not subject to the same regulatory approval process as prescription drugs.
- Description of the invention: The patent application needs to be described in a clear and concise manner, to make it easy for the patent office to understand the invention and its novelty.
- Technical expertise: It’s important to consult with a patent attorney or agent who has technical expertise in the pharmaceutical field, as well as familiarity with relevant case law, to help navigate the complexities of patenting OTC drugs.
- Industrial application: It is important to indicate the industrial application or potential of the invention in the patent application, as it is one of the key factors that will be considered by the patent office when examining the patent application.
Overall, it is important to consult with a patent attorney or agent who has experience in the pharmaceutical field and understands the complexities of patenting OTC drugs, to help navigate these considerations and to ensure that the company’s patent application(s) are as strong as possible.