In these situations, the FDA presumes these drugs are not therapeutically equivalent until the FDA has determined that there is adequate information to make a full evaluation of optioj equivalence. Before approving a generic product, the FDA requires many rigorous tests and procedures to ensure that the generic product can be substituted for the branded product. The FDA bases evaluations of substitutability or therapeutic equivalence of generic products on scientific evaluations. By law, a generic product must contain the identical amounts of the same active ingredients as the branded product.
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Generic products evaluated as therapeutically equivalent can be expected to have the opion clinical effect and safety profile as the branded, or reference, product when administered under the conditions specified in the labeling. When the disgram of a new drug believes sufficient evidence of diabram drug's safety and effectiveness has been obtained to meet the FDA's requirements for marketing approval, the sponsor submits an NDA to the FDA. The application must contain certain data about the drug, including information about chemistry, pharmacology, medical, biopharmaceutics and statistics. Some industry information is also based on our good faith estimates, which are derived from management's knowledge of, ii Table of Contents and experience in, our industry and the sources referred to above as well as information obtained from our customers, distributors, suppliers, trade and business organizations and other contacts in our industry.
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We believe these data to be accurate as of the date of this prospectus. However, this information may prove to be inaccurate because this information pyaoff always be verified with complete certainty due to the limitations on the availability and reliability of raw data, the voluntary payof of the data gathering process and other limitations and uncertainties. Industry publications, reports and surveys generally state that the information contained therein has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. In addition, our estimates of addressable markets are based, in part, on these market data and our actual market opportunities may be materially less than these estimates.
In addition, our name, logo and website name and address are our service marks or trademarks. Each trademark, trade name or service mark by any other company appearing in this prospectus belongs to its holder. We also own or have the rights to copyrights that protect the content of our products. Immediately prior to this offering, we will undertake a series of restructuring transactions that will result in Osmotica Pharmaceuticals plc becoming the direct parent company of Osmotica Holdings S. We refer to these transactions as the "Reorganization" throughout this prospectus.
You can immediately buy it back on the market for Above the strike, the put option has zero value, because digaram is no point exercising the right to sell the underlying at strike price when you can sell it for a higher price Europdan the option. What you can get when Ehropean the option What you have paid for the option in the beginning The first component is equal to the difference between strike price and underlying price. The lower underlying price gets relative to strike price, the higher your cash gain at expiration.
When it gets above, the result would be negative you would be losing money by exercising the option. Treatment could lead to unemployment, and in turn, to uninsurance or underinsurance. Patients feared catastrophic events because of diminished financial capacity and made strenuous efforts to prevent them. Transportation to and from haemodialysis centre, with variable availability and cost, was a common problem, aggravated for patients in non-urban areas, or with young children, and low resources.
Additional work for those uninsured or underinsured included fund-raising. In addition, we believe that our promoted products are protected by a combination of patent protection, data exclusivity and our optuon formulation and manufacturing know-how. Our key non-promoted products are comprised of complex formulations of generic drugs that incorporate our proprietary Osmodex drug delivery system. We have a history of developing commercially successful pharmaceutical products. Demonstrated Commercialization Capabilities. We have built a robust infrastructure for the commercialization of our pharmaceutical products.
With our specialized sales teams, we target approximately 18, physicians across the specialty neurology and women's health therapeutic areas. Our non-promoted products are supported by a team with extensive experience commercializing generic products in attractive markets. We support patients' access to our medications through careful research and a deep understanding of the changing reimbursement landscape.
Put Option Payoff Diagram and Formula
We have developed robust capabilities across the market access continuum underscored by successful payor contracting strategies and supplemental patient assistance programs. Patient access is central to the commercialization strategy for our recent and near-term product launches. Many of our existing products benefit from several potential barriers to entry, including intellectual property protection, formulation and manufacturing complexities, data exclusivity, as well as DEA regulation and quotas for API. Our proprietary Osmodex drug delivery system uses osmotic pressure to provide a controlled drug release and is adaptable to many different combinations of immediate-release, extended-release and controlled- or delayed-release formulations that contain one or more drugs.
We seek to identify and develop drug candidates that are well-suited to our proprietary Osmodex drug delivery system, which we believe can deliver a differentiated and favorable pharmacokinetic profile and may provide meaningful benefits to patients.
We believe that Europran parties attempting to compete with our products that use our proprietary Osmodex drug delivery system may face difficulties in developing a comparable product. Likewise, we believe that formulation complexities and manufacturing nephrkn limit the number of viable pahoff in the markets for our key generic products. Our current commercial success and historical cash flow generation allow us to diagran in our pipeline to support the next stage of our growth. Additionally, we opportunistically pursue strategic acquisitions and business development initiatives to augment our internal development pipeline.
Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of our ordinary shares and the distribution of this prospectus outside of the United States. This summary is not complete and does not contain all of the information that you should consider before investing in our ordinary shares. You should carefully read the entire prospectus, including the historical financial statements and related notes included elsewhere in this prospectus and the sections entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements," before deciding whether to invest in our ordinary shares.
Unless otherwise indicated or the context otherwise ophion, references to "we," "us," "our," "Osmotica" or the "company" refer to i prior to the diahram of the Reorganization, Osmotica Holdings S. All information in this prospectus assumes no exercise of the underwriters' option to purchase additional shares, unless otherwise noted. Our Company We are a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. Ontinua ER for muscle spasticity in multiple sclerosis patients, and RVL for blepharoptosis, or droopy eyelid. Many of our products use our proprietary osmotic-release drug delivery system, Osmodex, which we believe offers advantages over alternative extended-release, or ER, technologies.
Our core competencies span drug development, manufacturing and commercialization. Our specialized neurology and women's health sales teams support the ongoing commercialization of our existing promoted product portfolio as well as the launch of new products.
Long Put Option Position is Bearish
The cash flow from these non-promoted products has contributed to our robust investments in research and development and business development activities. Many of our existing products benefit from several potential barriers to entry, including intellectual property protection, formulation and manufacturing complexities, data exclusivity, as well as DEA regulation and quotas for active pharmaceutical ingredients, or API. Certain of our key products, particularly those that incorporate our proprietary Osmodex drug delivery system, are or are expected to be manufactured in our Marietta, Georgia facility. We plan to invest selectively in expanding our product portfolio by leveraging both our proprietary Osmodex drug delivery system to develop differentiated products as well as our management team's operating experience to pursue external business development opportunities.
Led by our Chief Executive Officer, Brian Markison, our management team has a proven track record of value creation in the pharmaceutical industry. Diversified Portfolio of Pharmaceutical Products. Through our specialized sales teams we promote a portfolio of specialty neurology and women's health products that we believe are differentiated from competing products and provide meaningful benefits to patients due to their formulation or pharmacokinetic profiles.