| Industries |
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| Automobile Manufacturers |
| Motorcycle Manufacturers |
| Managed Health Care |
| Automobiles and Components |
| Electrical Components and Equipment |
| Diversified Financial Services |
| Food Distributors |
| Trading Companies and Distributors |
| Health Care Distribution and Services |
| Independent Power Producers and Energy Traders |
| Exposures |
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| Economic |
| Crime |
| Judicial |
| Regime |
| Express intent |
| Event Codes |
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| Sports contest |
| Warn |
| Demand |
| Sanction |
| Yield to order |
| Endorse |
| Agree |
| Human death |
| Promise |
| Wiki | Wiki Summary |
|---|---|
| Uncertainty | Uncertainty refers to epistemic situations involving imperfect or unknown information. It applies to predictions of future events, to physical measurements that are already made, or to the unknown. |
| Propagation of uncertainty | In statistics, propagation of uncertainty (or propagation of error) is the effect of variables' uncertainties (or errors, more specifically random errors) on the uncertainty of a function based on them. When the variables are the values of experimental measurements they have uncertainties due to measurement limitations (e.g., instrument precision) which propagate due to the combination of variables in the function. |
| Fear, uncertainty, and doubt | Fear, uncertainty, and doubt (often shortened to FUD) is a propaganda tactic used in sales, marketing, public relations, politics, polling and cults. FUD is generally a strategy to influence perception by disseminating negative and dubious or false information and a manifestation of the appeal to fear. |
| Manufacturing | Manufacturing is the creation or production of goods with the help of equipment, labor, machines, tools, and chemical or biological processing or formulation. It is the essence of secondary sector of the economy. |
| List of computer hardware manufacturers | Current notable computer hardware manufacturers:\n\n\n== Cases ==\nList of computer case manufacturers:\n\n\n=== Rack-mount computer cases ===\n\n\n== Laptop computer cases ==\nClevo\nMSI\n\n\n== Motherboards ==\nTop motherboard manufacturers:\n\nList of motherboard manufacturers:\n\nDefunct:\n\n\n== Chipsets for motherboards ==\n\n\n== Central processing units (CPUs) ==\nNote: most of these companies only make designs, and do not manufacture their own designs. \nTop x86 CPU manufacturers:\n\nList of CPU manufacturers (most of the companies sell ARM-based CPUs, assumed if nothing else stated):\n\nAcquired or defunct:\n\n\n== Hard disk drives (HDDs) ==\n\n\n=== Internal ===\nList of current hard disk drive manufacturers:\n\nSeagate Technology\nToshiba\nWestern Digital\n\n\n=== External ===\nNote: the HDDs internal to these devices are manufactured only by the internal HDD manufacturers listed above. |
| Automotive industry | The automotive industry comprises a wide range of companies and organizations involved in the design, development, manufacturing, marketing, and selling of motor vehicles. It is one of the world's largest industries by revenue (from 16 % such as in France up to 40 % to countries like Slovakia). |
| List price | The list price, also known as the manufacturer's suggested retail price (MSRP), or the recommended retail price (RRP), or the suggested retail price (SRP) of a product is the price at which its manufacturer notionally recommends that a retailer sell the product.\nSuggested pricing methods may conflict with competition theory, as they allow prices to be set higher than would be established by supply and demand. |
| Successful (song) | "Successful" is a song by Canadian rapper Drake and R&B singer Trey Songz . The song features guest appearances from Drake's mentor and labelmate Lil Wayne. |
| The Successful Pyrate | The Successful Pyrate is a play by Charles Johnson, first performed 1712, published 1713, dealing with the life of the pirate Henry Avery. It opened at the Theatre Royal, Drury Lane on 7 November 1712 and ran for five evenings. |
| A Successful Failure | A Successful Failure is a 1934 American film directed by Arthur Lubin. It was Lubin's first film as director.There is no connection between the fictional radio personality "Uncle Dudley" in this film, and the 1935 comedy film Your Uncle Dudley, with Edward Everett Horton. |
| Generic brand | Generic brands of consumer products (often supermarket goods) are distinguished by the absence of a brand name, instead identified solely by product characteristics and identified by plain, usually black-and-white packaging. Generally they imitate more expensive branded products, competing on price. |
| Generic trademark | A generic trademark, also known as a genericized trademark or proprietary eponym, is a trademark or brand name that, because of its popularity or significance, has become the generic term for, or synonymous with, a general class of products or services, usually against the intentions of the trademark's owner.\nA trademark is said to become genericized—or, informally, to have suffered genericide—when it begins as a distinctive product identifier but changes in meaning to become generic. |
| Apotex | Apotex Inc. is a Canadian pharmaceutical corporation. |
| Combined oral contraceptive pill | The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be taken orally by women. It includes a combination of an estrogen (usually ethinylestradiol) and a progestogen (specifically a progestin). |
| Extended cycle combined hormonal contraceptive | Extended or continuous cycle combined oral contraceptive pills are a packaging of combined oral contraceptive pills (COCPs) that reduce or eliminate the withdrawal bleeding that would occur once every 28 days in traditionally packaged COCPs. It works by reducing the frequency of the pill-free or placebo days. |
| Desmopressin | Desmopressin, sold under the trade name DDAVP among others, is a medication used to treat diabetes insipidus, bedwetting, hemophilia A, von Willebrand disease, and high blood urea levels. In hemophilia A and von Willebrand disease, it should only be used for mild to moderate cases. |
| Fluid deprivation test | A fluid or water deprivation test is a medical test which can be used to determine whether the patient has diabetes insipidus as opposed to other causes of polydipsia (a condition of excessive thirst that causes an excessive intake of water). The patient is required, for a prolonged period, to forgo intake of water completely, to determine the cause of the thirst. |
| Von Willebrand disease | Von Willebrand disease (VWD) is the most common hereditary blood-clotting disorder in humans. An acquired form can sometimes result from other medical conditions. |
| Enuresis | Enuresis is a repeated inability to control urination. Use of the term is usually limited to describing people old enough to be expected to exercise such control. |
| Haemophilia A | Haemophilia, or hemophilia (from Ancient Greek αἷμα (haîma) 'blood', and φιλία (philía) 'love of'), is a mostly inherited genetic disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. This results in people bleeding for a longer time after an injury, easy bruising, and an increased risk of bleeding inside joints or the brain. |
| Regulation | Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. |
| Regulatory agency | A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulating capacity.\nThese are customarily set up to strengthen safety and standards, and/or to protect consumers in markets where there is a lack of effective competition. |
| Regulatory sign | A regulatory sign is used to indicate or reinforce traffic laws, regulations or requirements which apply either at all times or at specified times or places upon a street or highway, the disregard of which may constitute a violation, or a sign in general that regulates public behavior in places open to the public. The FHWA defines regulatory sign as "a sign that gives notice to road users of traffic laws or regulations". |
| Cis-regulatory element | Cis-regulatory elements (CREs) or Cis-regulatory modules (CRMs) are regions of non-coding DNA which regulate the transcription of neighboring genes. CREs are vital components of genetic regulatory networks, which in turn control morphogenesis, the development of anatomy, and other aspects of embryonic development, studied in evolutionary developmental biology. |
| Sport of athletics | Athletics is a group of sporting events that involves competitive running, jumping, throwing, and walking. The most common types of athletics competitions are track and field, road running, cross country running, and racewalking. |
| Round-robin tournament | A round-robin tournament (or all-play-all tournament) is a competition in which each contestant meets every other participant, usually in turn. A round-robin contrasts with an elimination tournament, in which participants are eliminated after a certain number of losses. |
| Patent | A patient is any recipient of health care services that are performed by healthcare professionals. The patient is most often ill or injured and in need of treatment by a physician, nurse, optometrist, dentist, veterinarian, or other health care provider. |
| Patent troll | In international law and business, patent trolling or patent hoarding is a categorical or pejorative term applied to a person or company that attempts to enforce patent rights against accused infringers far beyond the patent's actual value or contribution to the prior art, often through hardball legal tactics (frivolous litigation, vexatious litigation, strategic lawsuits against public participation (SLAPP), chilling effects, and the like). Patent trolls often do not manufacture products or supply services based upon the patents in question. |
| Significant Others | The term significant other (SO) has different uses in psychology and in colloquial language. Colloquially "significant other" is used as a gender-neutral term for a person's partner in an intimate relationship without disclosing or presuming anything about marital status, relationship status, gender identity, or sexual orientation. |
| The Simpsons | The Simpsons is an American animated sitcom created by Matt Groening for the Fox Broadcasting Company. The series is a satirical depiction of American life, epitomized by the Simpson family, which consists of Homer, Marge, Bart, Lisa, and Maggie. |
| Significant Mother | Significant Mother is an American television sitcom created by Erin Cardillo and Richard Keith. Starring Josh Zuckerman, Nathaniel Buzolic and Krista Allen, it premiered on The CW network on August 3 and ended its run on October 5, 2015. |
| Gross domestic product | Gross domestic product (GDP) is a monetary measure of the market value of all the final goods and services produced in a specific time period by countries. GDP (nominal) per capita does not, however, reflect differences in the cost of living and the inflation rates of the countries; therefore, using a basis of GDP per capita at purchasing power parity (PPP) may be more useful when comparing living standards between nations, while nominal GDP is more useful comparing national economies on the international market. |
| Pharmaceutical industry | The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. |
| Sun Pharma | Sun Pharmaceutical Industries Limited (d/b/a Sun Pharma) is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in more than 100 countries across the globe. It is largest pharma company in India and the fourth largest specialty generic pharmaceutical company in the world, with a total revenue of over US$4.5 billion as of June 2021. |
| Pharmacy | Pharmacy is the clinical health science that links medical science with chemistry and it is charged with the discovery, production, disposal, safe and effective use, and control of medications and drugs. The practice of pharmacy requires excellent knowledge of drugs, their mechanism of action, side effects, interactions, mobility and toxicity. |
| Anosmia | Anosmia, also known as smell blindness, is the loss of the ability to detect one or more smells. Anosmia may be temporary or permanent. |
| Aphantasia | Aphantasia is the inability to voluntarily create mental images in one's mind.The phenomenon was first described by Francis Galton in 1880 but has since remained relatively unstudied. Interest in the phenomenon renewed after the publication of a study in 2015 conducted by a team led by Professor Adam Zeman of the University of Exeter. |
| Risk Factors |
|---|
| BARR PHARMACEUTICALS INC ITEM 1A RISK FACTORS The statements in this section describe the major risks to our business and should be considered carefully |
| We provide the following cautionary discussion of risks, uncertainties and possibly inaccurate assumptions relevant to our business |
| These are factors that, individually or in the aggregate, we think could cause our actual results to differ materially from expected and historical results |
| Our business, financial condition or results of operations could be materially adversely affected by any of these risks |
| We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995 |
| You should understand that it is not possible to predict or identify all such factors |
| Consequently, you should not consider the following to be a complete discussion of all potential risks or uncertainties |
| See “Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations —Forward-Looking Statements |
| ” 29 _________________________________________________________________ [60]Table of Contents Competition from other manufacturers of generic drugs affecting our generic products The success of our generic business is based in part on successfully developing and bringing to market a steady flow of generic products |
| We attempt to select our generic products based on the prospects for limited competition from competing generic companies |
| We do so because we believe that the more generic competitors that market the same generic product, the lower the revenue and profitability we will record for our product |
| Therefore, if any of our currently marketed products or any newly launched generic product are subject to additional generic competition from one or more competing products, our price and market share for the affected generic product could be dramatically reduced |
| As a consequence, unless we successfully replace generic products that are declining in profitability with new generic products with higher profitability, our business could be adversely affected |
| Our largest single category of generic products is oral contraceptives, which accounted for approximately dlra400 million in revenues in fiscal 2006 |
| In addition, we recorded revenues of dlra90 million or more from each of two other generic products, Desmopressin, and royalties from the sale of a generic version of Allegra by Teva Pharmaceuticals |
| Two generic manufacturers have already launched a competing generic version of Desmopressin, and there are two competing generic Allegra products in addition to Teva’s |
| We anticipate added competition to Desmopressin and Allegra over time |
| In addition, we anticipate increasing competition to our generic oral contraceptives over time |
| Unless we can replace the anticipated losses of revenues from these products with revenues from new products, our revenues and profitability will suffer |
| Competition from other manufacturers of generic drugs affecting our proprietary products Upon the expiration or loss of patent protection or regulatory exclusivity periods for one of our branded products, or upon the “at-risk” launch by a generic manufacturer of a generic version of one of our branded products, we can lose the major portion of sales of that product in a very short period, which can adversely affect our business |
| For example, SEASONALE, our largest selling proprietary product, generated dlra100 million in revenues during fiscal 2006 |
| In May 2006 a competitor received tentative FDA approval for a generic version of SEASONALE and may be eligible for final approval following the expiration of our regulatory exclusivity on September 5, 2006 |
| If the competitor launches its product, our revenues and gross profit contributions from SEASONALE will decline significantly |
| Resolving Paragraph IV patent challenges Our operating results have historically included significant contributions from products that arise from the success we have had from our patent challenge activities |
| However, the success we have had in the past from 30 _________________________________________________________________ [61]Table of Contents challenging branded companies’ patents, whether through court decisions that permit us to launch our generic versions of product or through settlements, may not be repeated in the future due to the following: • an increase in the number of competitors who pursue patent challenges could make it more difficult for us to be first to file a Paragraph IV certification on a patent protected product; • a branded company’s decision to launch an “authorized” generic version of the product will reduce our market share and lower the revenues and gross profits we could have otherwise earned if an “authorized” generic were not launched; • claims brought by third parties, including the FTC, various states’ Attorneys General and other third-party payers challenging the legality of our settlement agreements could affect the way in which we resolve our patent challenges with the brand pharmaceutical companies; and • the efforts of brand companies to use legislative and regulatory tactics to delay the launch of generic products |
| Impact of “At Risk” launches There are situations where we have used our business and legal judgment and decided to market and sell products, subject to claims of alleged patent infringement, prior to final resolution by the courts, based upon our belief that such patents are invalid, unenforceable, or would not be infringed |
| This is referred to in the pharmaceutical industry as an “at risk” launch |
| The risk involved in doing so can be substantial because if a patent holder ultimately prevails, the remedies available to such holder include, among other things, damages measured by the profits lost by the holder which are often significantly higher than the profits we make from selling the generic version of the product |
| Should we elect to proceed in this manner we could face substantial damages if the final court decision is adverse to us |
| In the case where a patent holder was able to prove that our infringement was “willful”, the definition of which is subjective, such damages may be trebled |
| Government Regulation and Managed Care Trends The trend toward managed healthcare in the US, the growth of organizations such as HMOs and MCOs and legislative proposals to reform healthcare and government insurance programs could significantly influence the purchase of pharmaceutical products, resulting in lower prices and a reduction in product demand |
| Such cost containment measures and healthcare reform could affect our ability to sell our products and may have a material adverse effect on us |
| Additionally, reimbursements to patients may not be maintained and third-party payers, which place limits on levels of reimbursement, may reduce the demand for, or negatively affect the price of, those products and could significantly harm our business |
| We may also be subject to lawsuits relating to reimbursement programs that could be costly to defend, divert management’s attention and could have a material adverse effect on our business |
| Development and Regulatory Approval Risks and uncertainties particularly apply to whether or when our products will be approved |
| The outcome of the lengthy and complex process of developing new products is inherently uncertain |
| For our generic business, much of our product development efforts are focused on developing products that are difficult to formulate and/or products that require specialized manufacturing technology |
| The inability to successfully formulate and pass bioequivalence studies can adversely affect the timing of when we receive approval for our generic products |
| For our proprietary business, regulatory delays, the inability to successfully complete clinical trials or claims and concerns about safety and efficacy are a few of the factors that could adversely affect the timing of new 31 _________________________________________________________________ [62]Table of Contents proprietary product launches |
| In addition decisions by regulatory authorities regarding labeling and other matters could adversely affect the availability or commercial potential of our products |
| There can be no assurance as to whether or when we will receive regulatory approval for new products |
| Product Manufacturing and Marketing Difficulties or delays in product manufacturing or marketing, including, but not limited to, the inability to increase production capacity commensurate with demand, or the failure to predict market demand for, or to gain market acceptance of approved products, including our recent launches of SEASONIQUE and ENJUVIA, could affect future results |
| Dependence on third parties We rely on third parties to supply us with raw materials, inactive ingredients and other components for our manufactured products and for certain of our finished goods |
| In many instances there is only a single supplier |
| In addition, we rely on third-party distributors and alliance partners to provide services for our business, including product development, manufacturing, warehousing, distribution, customer service support, medical affairs services, clinical studies, sales and other technical and financial services for certain of our products |
| Nearly all third-party suppliers and contractors are subject to FDA, and in some cases DEA, requirements |
| Our business on some products are dependent on the regulatory compliance of these third parties, and on the strength, validity and terms of our various contracts with these third-party manufacturers, distributors and collaboration partners |
| Any interruption or failure by these suppliers, distributors and collaboration partners to meet their obligations pursuant to various agreements or obligations with us could have a material adverse effect on our business |
| In addition, our revenues include amounts we earn based on sales generated and recorded by Teva Pharmaceuticals for generic Allegra, and Kos Pharmaceuticals for Niaspan and Advicor |
| Any factors that negatively impact the sales of these products could adversely impact our revenues and profits |
| Customer consolidation Our principal customers are wholesale drug distributors and major retail drug store chains |
| These customers comprise a significant part of the distribution network for pharmaceutical products in the US This distribution network is continuing to undergo significant consolidation marked by mergers and acquisitions among wholesale distributors and the growth of large retail drug store chains |
| This consolidation may result in these groups gaining additional purchasing leverage and consequently increasing the product pricing pressures facing our business |
| Additionally, the emergence of large buying groups representing independent retail pharmacies and the prevalence and influence of managed care organizations and similar institutions potentially enable those groups to attempt to extract price discounts on our products |
| Our net sales and quarterly growth comparisons may be affected by fluctuations in the buying patterns of major distributors, retail chains and other trade buyers |
| These fluctuations may result from seasonality, pricing, wholesaler buying decisions or other factors |
| Cost and Expense Control/Unusual Events Growth in costs and expenses, changes in product mix and the impact of acquisitions, divestitures, restructurings, product withdrawals and other unusual events that could result from evolving business strategies, evaluation of asset realization and organizational restructuring could create volatility in our results |
| Such risks and uncertainties include, in particular, the potentially significant charges to our operating results for items like in-process research and development charges and transaction costs |
| Legal Proceedings |