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A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
Prescription drug prices in the United States continually rank among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the U.S. health care reform debate of 2009, and received renewed attention in 2015. High prescription drug prices have been attributed to government-granted monopolies to manufacturers and organizations lacking ability to negotiate prices.
A prescription drug is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.
Many countries have measures in place to limit advertising by pharmaceutical companies.
Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, Telangana, India. The company was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.
Pharmaceutical sales representatives are salespeople employed by pharmaceutical companies to persuade doctors to prescribe their drugs to patients. Drug companies in the United States spend ~$5 billion annually sending representatives to doctors, to provide product information, answer questions on product use, and deliver product samples. These interactions are governed according to limits established by the Code on Interactions with Health Care Professionals, created by the Pharmaceutical Research and Manufacturers of America (PhRMA). This code came into practice in 2002 and has since been updated to help define ethical interactions between health care professionals and the pharmaceutical companies
The pharmaceutical industry is one of the leading industries in the People's Republic of China, covering synthetic chemicals and drugs, prepared Chinese medicines, medical devices, apparatus and instruments, hygiene materials, packing materials, and pharmaceutical machinery.
Perrigo Company plc is an Irish–registered manufacturer of private label over-the-counter pharmaceuticals, and while 70% of Perrigo's net sales are from the U.S. healthcare system, Perrigo is legally headquartered in Ireland for tax purposes, which accounts for 0.60% of net sales. In 2013, Perrigo completed the 6th-largest U.S. corporate tax inversion in history when it reregistered its tax status to Ireland to avoid U.S. corporate taxes.
The pharmaceutical industry in India was valued at US$33 billion in 2017 and generic drugs account for 20 per cent of global exports in terms of volume, making the country the largest provider of generic medicines globally. According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, domestic pharmaceutical market turnover reached Rs 129,015 crore in 2018, growing 9.4 per cent year-on-year and exports revenue was US$17.28 billion in FY18 and US$19.14 billion in FY19.Hyderabad, Mumbai,Pune,Baddi, Himachal Pradesh, Chennai, Bangalore, Ahmedabad, Vadodara, Ankleshwar, Vapi, Sikkim and Kolkata are the major pharmaceutical hubs of India.
IMS Health was an American company that provided information, services and technology for the healthcare industry. IMS stood for Intercontinental Medical Statistics. It was the largest vendor of U.S. physician prescribing data. IMS Health was founded in 1954 by Bill Frohlich and David Dubow. In 2010, IMS Health was taken private by TPG Capital, CPP Investment Board and Leonard Green & Partners. The company went public on April 4, 2014 and began trading on the NYSE under the symbol IMS. IMS Health was headquartered in Danbury, Connecticut.
Teva Pharmaceutical Industries Ltd., also known as Teva Pharmaceuticals, is an American Israeli pharmaceutical company with dual headquarters in Petah Tikva, Israel (global) and Parsippany, New Jersey, U.S. (commercial). It specializes primarily in generic drugs, but other business interests include active pharmaceutical ingredients and, to a lesser extent, proprietary pharmaceuticals. It is the largest generic drug manufacturer in the world and one of the 15 largest pharmaceutical companies worldwide.
Hikma Pharmaceuticals is a multinational pharmaceutical company with headquarters in London, UK that manufactures non-branded generic and in-licensed pharmaceutical products. It was founded by Samih Darwazah in Amman, Jordan in 1978. It is listed on the London Stock Exchange and is a constituent of the FTSE 100 Index.
In the United States, a pharmacy benefit manager (PBM) is a third-party administrator of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, and state government employee plans. According to the American Pharmacists Association, "PBMs are primarily responsible for developing and maintaining the formulary, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims." PBMs operate inside of integrated healthcare systems, as part of retail pharmacies, and as part of insurance companies.
Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. Authorized generics compete with generic products in that they are identical to their brand counterpart in both active and inactive ingredients; whereas according to the U.S. Food and Drug Administration's Office of Generic Drugs, generic drugs are required to contain only the identical active ingredients as the brand. Authorized generics compete with generics on price, quality and availability in the generic marketplace, and are marketed to consumers during and after what is commonly known as “the 180-day exclusivity period”.
Simcere Pharmaceutical Group or Simcere Pharmaceutical is a manufacturer and supplier of branded generic pharmaceuticals in the Chinese market. Its focus is to introduce generic and pharmaceutical products for the treatment of diseases with high incidence and/or mortality rate. The Company has introduced a generic anti-stroke medication under the brand name, Bicun, and an anti-cancer medication under the brand name, Endu. Its products include antibiotics, anti-stroke medications, anti-inflammatory drugs, anti-cancer medications and other medicines. In addition, it has obtained approvals from the China State Food and Drug Administration (SFDA) to manufacture and sell over 210 other products.
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Lupin Limited is an Indian multinational pharmaceutical company based in Mumbai, Maharashtra, India. It is one of the largest generic pharmaceutical companies by revenue globally. The company's key focus areas include paediatrics, cardiovascular, anti-infectives, diabetology, asthma and anti-tuberculosis.
This article is about the history of the United States Food and Drug Administration.
Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals that are classified as high-cost, high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectable or infused. They are used to treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V. psoriasis, inflammatory bowel disease and hepatitis C. In 1990 there were 10 specialty drugs on the market, in the mid-1990s there were fewer than 30, by 2008 there were 200, and by 2015 there were 300. Drugs are often defined as specialty because their price is much higher than that of non-specialty drugs. Medicare defines any drug for which the negotiated price is $670 per month or more, as a specialty drug which is placed in a specialty tier that requires a higher patient cost sharing. Drugs are also identified as specialty when there is a special handling requirement or the drug is only available via a limited distributions network. By 2015 "specialty medications accounted for one-third of all spending on drugs in the United States, up from 19 percent in 2004 and heading toward 50 percent in the next 10 years", according to IMS Health, which tracks prescriptions. According to a 2010 article in Forbes, specialty drugs for rare diseases became more expensive "than anyone imagined" and their success came "at a time when the traditional drug business of selling medicines to the masses" was "in decline". In 2015 analysis by The Wall Street Journal suggested the large premium was due to the perceived value of rare disease treatments which usually are very expensive when compared to treatments for more common diseases.
References
- ↑ IMS National Sales Perspectives & National Prescription Audit, 2005, 2006
- ↑ Ritchie, James (2006-02-03). "Prasco's market share Rx: authorized generic drugs". Business Courier of Cincinnati.
- ↑ "Prasco in deal for generic Allegra" (fee required). Pharma Marketletter. 2005-07-01.
- ↑ "Prasco to market generic Allegra". Business Courier of Cincinnati. 2005-10-14.
- ↑ "Prasco ships generic Cyclessa" (fee required). Drug Topics. 2004-09-04.
- ↑ "Archived copy". Archived from the original on 2008-04-08. Retrieved 2008-03-11.CS1 maint: archived copy as title (link)
- ↑ "Prasco Laboratories: Over 80 percent of Americans Want the Option of Authorized Generic Prescription Drugs; Research Underlines Consumer Demand to Have Authorized Generic Prescription Drugs Available" (fee required). Business Wire. 2005-07-01.
