person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Generic Drugs. Active ingredient: Form/Route: Recommended studies: 1. Ramipril Capsule/ Oral 2 studies Type of study: Fasting Design: Single-dose, two-treatment, two-period crossover in-vivo Strength: 10 mg Subjects: Normal healthy males and females
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LOS Angles times Drug makers try to stall generics March 17, 2008|Melissa Healy | Times Staff Writer For the makers of brand-name prescription drugs, generic competition is about as welcome as a virus. In the first year that a generic competitor goes on the market, a brand-name drug loses on average more than half of its market share, and its price drops with each new generic company that produces a copycat, May 2005 study said. So companies that are about to face that competition have big
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Table of Content Introduction/Overview……...………………………………………………….........2-3 Strengths...………………………………………………………………………......3-4 Weaknesses...……………………………………………………………..…………...4 Opportunities…………………………………………………………………….......4-5 Threats…….……………………………………………………………..………….....5 External Factors Impacting Decisions………………………………………………5-7 Possible Future Scenarios…………………………………………………………...7-8 Recommendations for Changes in Culture, Leadership, and/or Structure…………..8-9 Summary/Conclusions………………………………………………………………
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Southern University – DBA 7035 Patent Games: Plavix Case Study This paper will take a close look at some of the issues surrounding Apotex in the early 2000s. This company was working increasingly hard to break into the U.S. Market with their generic version of clopidogrel bisulfate, also known as Plavix. In addition, this paper will also explore how Sanofi-Aventis and Bristol-Meyers tried to maximize on forming monopolies to wean out their competitors, but instead caused more issues for their
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industries, with the Palestinian companies owning 55% and 30% market share of the private and public sectors respectively, and high potential of growth even more, in a market estimated at around USD 100 million. All these companies mostly reproduce generics that are seen as commodities rather than differentiated, and highly depend on preferred agreements with pharmacies, doctors, hospitals and medical centers to serve both as their marketing and distribution channels. All operating firms in the industry
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are to result from it: • The new entity/firm will be the world’s fifth largest specialty-generic pharma company with sales of US$ 4.2 billionfor CY 2013. • The entity will have a presence in 55 countries and be supported by 40 manufacturing facilities worldwide, with a highly complementary portfolio of products for both acute and chronic treatments. • In the U.S., the merged entity will be No.1 in the generic dermatology market and No. 3 in the branded dermatology market. It will also become the
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Introduction An investigation into a pharmaceutical company’s supposed intentions to curtail generic competition regarding an antidepressant drug, which is the company’s best brand name seller, has brought about a few questions as to why the company would do this to consumers. Prescription medication is expensive enough without pharmaceutical companies hindering the market entry of its generic counterparts. Generic medication gives consumers a choice to spend more or to spend less for their health
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since insurance and social security do not cover all the costs, the elderly are paying out of pocket for their medications. Employees in the medical field should prescribe drugs that treat multiple symptoms, suggest substituting brand names for generic names, and navigate patients to cost effective programs. Healthcare administrators need to create a policy for medical staff that will require them to monitor and provide more financially suitable healthcare options for elderly consumers in addition
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stakeholders are first and foremost patients. They receive free samples. The argument is that if physians are pampered by detailers, then they would prescribe more non generic drugs. I don’t agree with that assumption. The public must understand that once the patent runs out on a drug, then it can be produced by competitors in generic form. Physicians would have no incentive to write one RX over another. The Issue is that Detailers have resources to “pamper” physicians and influence their decision
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pharmaceutical company in Bangladesh .The Company was founded in 1958 by Samson H. Chowdhury along with three of his friends as a private firm. It was converted into a public limited company in 1991. It is engaged in the manufacturing of branded generic pharmaceutical products and also other ethical drugs and medicines. The company formulation facilities include Pabna Unit, Dhaka Unit, Pesticide Unit, Cephalosporin Unit and Animal Health Unit. Square Pharmaceuticals Limited has extended its range
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