Glossary of Abbreviations ANDA APhA Abbreviated New Drug Application American Pharmaceutical Association API Active Pharmaceutical Ingredient BA/BE Bioavailability/Bioequivalence BE Bioequivalence Bio INDs Bio Investigational New Drug Application Biologic License Applications BLAs bn BPE Billion Bulk Pharmaceutical Excipient CAGR Compound Annual Growth Rate CAS Chemical Abstracts Service CBER Center for Biologics Evaluation and Research (FDA) CDER Center for Drug Evaluation and Research (FDA) CDRH Center for Devices and Radiological Health (FDA) CFR CFSAN Code of Federal Regulations Center for Food Safety and Applied Nutrition (FDA) cgmp Current Good Manufacturing Practice 22
CMIE Centre for Monitoring Indian Economy CNS CoS Central nervous system Certificate of Suitability CP Citizen Petition CPP Certificate of Pharmaceutical Product CRAMS CT Contract Manufacturing and Research services Clinical Trial CTA Clinical Trial Application CVS Cardio Vascular System DESI Drug Efficacy Study Implementation DGCI&S DHHS Director General of Commercial Intelligence and Statistics Department of Health and Human Services (U.S.) DMF Drug Master File DP Drug Product DPC-PTR Act Drug Price Competition and Patent Trade Restoration Act of 1984 Drug Substance DS DSI ectd Division of Scientific Investigation Electronic Common Technical Document EMEA European Agency for Evaluation of Medicinal Products EU FD&C ACT European Union Federal Food, Drug, and Cosmetic Act of 1938 FDC Food, Drug, & Cosmetic FFDCA Federal Food, Drug, and Cosmetic Act of 1938 FR Federal Register GCLP Good Clinical Laboratory Practice GCP Good Clinical Practice GDEA Generic Drug Enforcement Act of 1992 GLP Good Laboratory Practice GMP Good Manufacturing Practice GPhA Generic Pharmaceutical Association 23
HMG COA HS Codes INDA IRB mn MNC NCE NCIE NDA NDC Directory NME NIPER NSAID NTI OGD (CDER) ONL OTC PAC PHARMEXCIL PHSA PTO PTR RAPS RLD ROW Rx SEC filings SITC TE TE Codes TRIPS UK US US FDA USA 5 Hydroxyl Methyl Glutaryl Co enzyme Harmonized system of codes Investigational New Drug Application Institutional Review Board Million Multi National Corporation New Chemical Entity National Center for Import and Export (USDA) New Drug Application National Drug Code (FDA) Directory New Molecular Entity National Institute for Pharmaceutical Education Research Non-steroidal Anti-Inflammatory Drug Narrow Therapeutic Index Office of Generic Drugs (CDER) and Over due notice letter over the counter Post Approval Changes Pharmaceuticals Export Promotional Council Public Health Service Act of 1944 Patent and Trademark Office (U.S. Department Commerce) Patent Term Restoration Regulatory Affairs Professionals Society Reference Listed Drug Rest of the world Recipe Securities and Exchange Commission filings Standard International Trade Classification Therapeutic Equivalence Therapeutic Equivalence Code Trade Related aspects of Intellectual Property Rights United Kingdom United states United States Food and Drug Administration United states of America 24 of
USP USPTO WHO WL WW YoY United States Pharmacopeia United States Patent and Department of Commerce) World health organization Warning Letter World wide Year over Year Glossary of Terms Trademark Office (U.S. Abbreviated New Drug Application (ANDA): An Abbreviated New Drug Application (ANDA) contains data submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical and clinical data to establish safety and effectiveness ANDA demonstrate that its product is bioequivalent as the innovator drug. Active Ingredient/Drug Substance: According to 21 CFR 210.3(b)(7) and 314.3, an active ingredient is any component of a drug product that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease, not include intermediates. Authorized generics: Authorised generics are brand products masquerading as generics compete with the true generic during the 180 day marketing exclusivity period maintaining the higher price for the brand drug. ANDA Suitability Petition: ANDA suitability petitions are submitted to FDA using the format for a citizen petition approves or disapproves an ANDA suitability petition within 90 days. Bioavailability: This term means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. Branded Medicines: A drug that has a trade name and is protected by a patent (can be produced and sold only by the company holding the patent). 25
Blockbusters: industry term referring to drugs with very large sales, generally in excess of $1 billion. Branded generics: Generic drugs for which a drug manufacturing company has attached its brand name and may have invested in its marketing to differentiate it from other generic brands. Bioequivalence: Bioequivalence means that the active ingredient in a generic medicine is absorbed into the body at the same rate and amount as in the brand-name product. BIO IND : The Bio-IND is required by regulations, as per 21 CFR 320.31(a), to ensure that proposed products that are not new drugs(nda or ANDA) are safe for use in human test subjects. Biologic License Application (BLA): A biologics license application under Public Health Service (PHS) Act is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. Biological Product: Biologics are isolated from a variety of natural sources. Biogenerics: A generic drug originated from Biological source has emerged from patent protection and can be manufactured by a company other than RLD using either identical or different manufacturing processes. Bulk drugs: The active chemical substances in powder form, the main ingredient in pharmaceuticals having therapeutic value, used for the production of pharmaceutical formulations. Citizen petition : A citizen petition is a written request for challenging any actions taken by FDA employed to challenge the approval of ANDA or 505(b)(2) applications. Data exclusivity: Data exclusivity guarantees additional market protection for originator pharmaceuticals by preventing health authorities from accepting applications for generic medicines during the period of exclusivity. Discontinued Section: The identification of these drug products in the Discontinued Section of the Orange Book should avoid the submission of multiple citizen petitions for the same drug product. Discontinued Drug Product: Products listed in Drugs@FDA as "discontinued" are approved products that have never been marketed, have been discontinued from marketing, are for military use, are for export only, or have had their approvals withdrawn for reasons other than safety or efficacy after being discontinued from marketing. Dosage Form: A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable. 26
Drug: A drug is defined as a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Drug Product: A finished dosage form, for example, tablet, capsule, or solution, that contains an active ingredient. Drug Master files (DMFs): Generic registration applications filed with the U.S.FDA in order to allow the active pharmaceutical ingredients (APIs) to appear in marketed drugs. Desi Drugs: FDA initiated a Drug Efficacy Study Implementation (DESI) to evaluate the effectiveness of those drugs that had been previously approved on safety grounds alone. FDA Application Number: This number, also known as the NDA (New Drug Application) number, is assigned by FDA staff to each application for approval to market a new drug in the United States. Formulations: Drugs ready for consumption by patients (generic drugs) sold as a brand or generic product as tablets, capsules, injectables, or syrups. Generic Drug: A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Innovator drugs: Are drugs with patents on their chemical formulation or on their production process have been tested and approved by the U.S. FDA after extensive clinical trials. Marketing Status: Marketing status indicates how a drug product is sold in the United States. Drug products in Drugs@FDA are identified as Prescription,Over-the-counter,Discontinued. Market Exclusivity: The effective period of market exclusivity gained by the originator company is the period of data exclusivity plus the time it takes to register and market the generic medicine. New Drug Application (NDA): When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA) data including chemistry, pharmacology, medical, biopharmaceutics, and statistics. New Molecular Entity (NME): A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form. 27
National Drug Code: National drug code (NDC) was originally established in connection with the reimbursement program under Medicare. Orange Book: Orange Book is commonly known as Approved Drug Products with Therapeutic Equivalence Evaluation compiled by FDA and lists all approved drugs along with their official and proprietary names also stores Prescription drugs (Human), OTC drugs (Human), Discontinued drugs (Human) and patent and exclusivity listing. Over-the-Counter Drugs (OTC): FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription. Pharmaceuticals: Are used to prevent, diagnose, treat, or cure diseases in humans and animals. Plain vanilla generics: Commodity generics that are off-patent in the regulated markets. They offer little or no innovative value over the innovator s product. Proprietary drugs: Drugs that have a trade or brand name and are protected by a patent. Pharmaceutical Equivalents: FDA considers drug products to be pharmaceutical equivalents if they contain the same active ingredient(s), same dosage form and route of administration, identical in strength or concentration. Prescription Drug Product: A prescription drug product requires a doctor's authorization to purchase. Patent: Patents are registrable provides a patentee the right to prevent anyone making, using, selling, or importing the invention for 20 years. Patents can be expired before drug approval, issued after drug approval, and anywhere in between. Exclusivity is granted upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity protection while others has just one or none. Patent Delist: In the event of the filing of a patent infringement action based on an ANDA or 505(b)(2) application, the applicant may assert a counterclaim to correct or delete the patent list if the patent listing if the patent does not claim the approved drug or an approved method of use. Patent Certifications: There are four types of patent certification issued by the FDA. They are Paragraph I (No patents for the reference listed drug were listed in the Orange book), Paragraph II (Patents were listed in the Orange book but they all have expired on the date of submission is sent to the FDA), Paragraph -III (the patent has not expired but will expire on a particular date) and Paragraph IV) are submitted when the applicant is challenging the patent(s). Patent settlements: To ensure prompt generic market entry and to punish companies that might enter into an anticompetitive agreement some agencies can request changes to settlements, and take the appropriate action. 28
RLD (Reference Listed Drug): A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Tentative Approval: If a generic drug product is ready for approval before the expiration of patents FDA issues a tentative approval letter to the applicant but does not allow the applicant to market the generic drug product. Therapeutic Biological Product: A therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease. Therapeutic Equivalence (TE): Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Therapeutic Equivalence (TE) Codes: FDA assigns therapeutic equivalence codes to pharmaceutically equivalent drug products like "A" rated if not "B" rated. Over the counter drugs are not assigned TE codes. 29