In the year 2003, the Brussels based pharmaceutical company, Solvay Pharmaceuticals received a patent for Androgel, its brand-name drug, which is utilized as a remedy for low levels of testosterone in men. Actavis, another large pharmaceutical, subsequently applied for patents for generic drugs that were developed with Androgel as the model. Solvay Pharmaceuticals proceeded to sue Actavis claiming the company violated “Paragraph IV” of the Hatch-Waxman Act which states that if approved, a drug product has “exclusive, or monopoly, status in the market for a certain number of years (five years for a new chemical entity and other periods of time for different situations). Under this law, the FDA is unable to legally approve a generic drug application until the end of the exclusivity period or for a 30-month period while the courts attempt to settle the dispute. After three years of litigation between Solvay Pharmaceuticals and Actavis, the FDA approved the patent for the generic drug.…
Under the Hatch-Waxman regime, a brand-name company seeking 26 FDA approval for a new drug must file a new drug application (NDA). In addition to detailed information about the properties of the drug, the application must include "the patent number and the expiration date of any patent which claims the drug . . . or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted," and this information must be amended as new patents are issued.27 After the drug is approved, the FDA must make this list public. 28 The FDA publication containing new drug information is known as the Orange Book, and it may be searched freely…
For most of the medications you might get a reduced rate due to your plan and sometimes you can only get the generic brand. Some pharmacies might offer some of the most widely commonly used medications at a set reduced price of $3.00$ 4.00. A Lot of insurance companies now will require that medications that are needed for more than 30 days need to be processed through the mail order services. In Great Britain all medications are covered by the NHS and there is no extra cost to the patient. b.…
The ever increasing drug prices continue to hinder equitable health care. However, pharmaceutical companies continue to seemingly have unabated control over life-saving medication. This article will examine existing federal and state price gouging laws and determine its efficacy in preventing medication price hikes. From an objective stand point, this article will analyze the benefits and complications related to regulating drug prices on the market in order to make relevant propositions that would help alleviate overwhelming prescription drug…
The Wall Street Journal writer, Drew Altman, states that “seventy-six percent of the public blames drug companies for high drug prices – with just ten percent blaming insurers” (Altman). Since the main buyers of medications are private insurers and the federal government, the pricing decision commonly does not consider the patient’s affordability. Pharmaceutical firms such as Medicare are not allowed to discuss prices with manufacturers while the Food and Drug Administration (FDA) does not consider cost in medication approval at all. Rare value and lack of alternatives influence high costs and “although some price increases have been caused by shortages, others have resulted from a business strategy of buying old neglected drugs and turning them into high-priced ‘specialty drugs’” (Pollack).…
As mentioned before, drugs are perishable products even though the expiry date is long. Inventory management of those is difficult and pharmacies know how many types of medicines (and units) they can sell and adjust their orders. However, a prescription drug is different. Doctors prescribed it to patients and pharmacies sell according to this. Different manufacturers create the same core ingredient in those drugs, leading to a competition influenced by lobbying.…
The researchers created three scenarios for a universal public drug plan: best- and worst-case, and a “base” scenario, which is the expected outcome. They found that most prescriptions are already paid for by government, through tax revenues, with $9.7 billion spent directly on public drug plans and $2.4 billion spent on private drug plans for public-sector employees. Private-sector spending on private insurance plans currently accounts for $5.7 billion, and uninsured patients pay $4.5 billion out-of-pocket for prescriptions they fill.…
To which the general public will buy their medications from. “They are accusing 22 drug manufacturers of illegally conspiring to fix prices by offering discounts to health maintenance organizations and others but not to retail pharmacies.” “Freudenheim,…
The key elements of Under Armour’s strategy: Under Armour’s mission is “To make all athletes better through passion, design and the relentless pursuit of innovation.” There are three main strategies that Under Armour uses: 1. Growth Strategy: - Continuation to broaden the company’s product offering to individuals in a variety of sports and activities - To achieve sales revenue of $4 billion by 2016, up from an estimated $2.2 billion in 2013. - Develop the global awareness of brand name and strengthening its appeal. 2.…
These two methods in the articles described a way to change the regulation of how pharmaceuticals adjust their…
I. Jaime is a 27 year old college graduate who does not have health insurance. She said “Every time I get sick, if it can't be fixed with Advil, NyQuil and a good night's sleep I don't really have a solution for it. If something bad happened to me... there's no possible way I could afford it.” (Jaime’s Story) II.…
Some have even added a new category to include specialty drugs where the patient has to pay more. All of these factors coupled with the rising drug prices, is making it extremely hard for patients to afford these prescription drugs. There was a poll conducted and almost a quarter out of 648 people said that could not refill a prescription in the past year because of the rise in costs. Those that are prescribed a brand name drug compared to a generic brand were also found not to comply with their regimen, and this obviously causes a decrease in their health outcome. The United States puts so much money into making these drugs that they do not put as much effort into actually making them affordable.…
i. The two companies that were selected are Pfizer and Johnson & Johnson. First of all, Pfizer, Inc. is a research-based, global biopharmaceutical company which it focuses in improving the health standards locally or globally by manufacturing vaccines and injectable biologic medicines. Basically Pfizer operates under a few business segments such as Global Pharmaceutical, Global Vaccines, Oncology and Consumer Healthcare and Global Established Pharmaceutical. Unlike Pfizer, Johnson & Johnson is an investment holding company which focuses its interest towards health care products.…
In turn, pharmaceutical prices have also increased, as seen with the price of the EpiPen. Furthermore, a study done by the Congressional Budget Office emphasizes the lack of the output of new drugs in recent years, which highlights the need for an increase in further research and development (“Research and Development,” 2006). This being said, society’s need for new, innovative pharmaceuticals is only possible through further research and development, which requires sufficient funding from pharmaceutical companies that is attained through drug…
The core of the pharmaceutical industry problems consists of the expiration of patents, rising R&D expenses, and uncertainties facing new researched products and their abnormal methods of circulation of returns from said product. As rooted in the topic of this case AstraZeneca upholds the gold of innovatively changing the way medicine reaches patients. When patents are first granted there are procedures that followed before a drug reaches the marketplace. Due to the extended timeframe that is required for clinical trials, studies and organizational processes to tested and developed the revenue phase of the drug decreases (Hitt, Ireland, & Hoskisson, 2015). More specifically after the developed drug is ready for sale the patent remaining on these products are near expiration.…