User:Iamelephant/Proprietary Drug

= Proprietary Drug = Proprietary drugs are patented medication produced by inventors. Legally speaking, all available drugs are proprietary as their formulations are protected by laws and can only be manufactured and marketed by the owner of the patent. Nevertheless, the former definition is usually used in common sense.

Thanks to intellectual property, the proprietary drug is a substantial business for the pharmaceutical industry. They are usually sold at a higher price to compensate for the development cost and sometimes manufacturing with new technology. Lyrica, a recently off-patent painkiller for the spinal cord, had a sale of 1.19B USD, out of the 13.12B USD annual revenue of the corresponding company. Not all drugs have generic replacements available. Biologics are often produced by in vitro preparation and direct extraction of substances from living organisms. Pharma is not extensively involved in searching for ready-to-sell generic biologics due to the complexity of manufacture and hurdles in extraction processes. Capital is also a significant push factor. Usually, these endogenous chemicals are prescribed to patients suffering from severe conditions, such as complicated chronic diseases and cancer. Patients taking a particular brand of biologics are unable to interchange between one to another to prevent underlying exposure to more side effects and/or suboptimal treatment.

Terminology

 * Proprietary drugs: drugs that are released by its patent owner
 * Brand name drugs: drugs that are marketed with a trade name, can be either proprietary or generic (but generic drugs are often marketed with the name of the API instead)
 * Generic drug: drugs that have the same active ingredient as a patent-expired drug.

Examples of Pharmaceutical Companies and their Representative Ex- and current Proprietary Medicine

 * Pfizer: Viagra (sildenafil), Comirnaty (Tozinameran) (co-op with BioNTech), Celebrex (Celecoxib)
 * GlaxoSmithKline (GSK): Amoxil (amoxicillin), Ventolin (salbutamol), Zyban (bupropion)
 * Sanofi: Plavix (clopidogrel), Allegra (fexofenadine)

Regulations
To support scientific investigation and protect intellectual properties, patents are granted for companies and individuals who invented the drug or owned the drug by purchasing the ownership. Most entities in the world have established corresponding agendas legally. Here are some examples:

World Trade Organization
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set up in 1994 suggested a standard on Intellectual Property Rights, which proprietary drug, a type of pharmaceutical and scientific inventions, is covered in this agreement Basic principles such as the minimum duration of patent and part of the exclusive rights of patent owners are included by World Trade Organization (WTO) member states in their respective national regulations. By 5 years and 10 years after the effectiveness of TRIPS, more developed countries and developing countries were required to comply with it.

Taking the necessary need for affordable medications for developing countries, WTO had waived the implication of TRIPS for developing countries. The latest deadline is 2033, and that the developing member states are still working their best to seek a protective legal system to facilitate Intellectual Property Rights and medical advancements.

US
In the United States, proprietary drugs are associated with two statuses: patent and exclusivity. The patent is managed by the United States Patent and Trademark Office, granting inventors of new drugs rights for 20 years. It is opened to all drugs, regardless of their research or commercialization status. To enjoy the benefits brought by patenting, pharmaceutical companies are obliged to disclose all research data on that drug to the public for further progression. Exclusivity, given by the U.S. Food and Drug Association (FDA), means a period in which no other competitor drugs can be approved. Commercialized and clinically used drugs are the targets of exclusivity. The length of exclusivity depends on the nature of the application and ranges from 1 to 7 years. Practically exclusivity is granted for proprietary drugs that have been granted with patent, but it is not mandatory. Legalwise, generic counterparts have to wait for at least 2 decades for patent expiration to sell a copy. This system is said to aim for a balance between gaining public access to generic drugs and encouraging drug research and development.

India
According to the Patent Law in India, only drug manufacturing methods can apply for a patent. Registering a drug for a patent in India is more limiting than in the more developed countries. India is one of the developing member states in the WTO and is therefore yet to have a TRIPS-complied intellectual property rights legal system.