Blockbuster Drug

A pharmaceutical product that contains the same active ingredient, dosage form, strength, and route of administration as an originator (branded) drug and is demonstrated to be bioequivalent. Generic drugs can be manufactured and marketed after the expiry of the originator's patent protection and regulatory exclusivity periods.

A regulatory status granted to drugs developed to treat rare diseases affecting small patient populations, providing incentives such as market exclusivity (7 years in the US, 10 years in the EU), tax credits on clinical trial costs, and reduced regulatory fees. Orphan drug designation significantly enhances the economic value of a pharma intangible asset by creating protected market positions.

The regulatory process by which a pharmaceutical product receives authorisation for commercial sale, granted by agencies such as the FDA (US), EMA (EU), and MHRA (UK). Drug approval requires demonstration of safety, efficacy, and manufacturing quality through preclinical studies and clinical trials.

The sharp decline in revenue experienced by a pharmaceutical or technology company when patent protection expires on a key product, exposing it to generic or competitive alternatives. Patent cliffs are a critical consideration in the valuation of patent-dependent businesses, as revenue can decline 70-90% within 12-24 months of patent expiry in the pharmaceutical sector.

The authorisation granted by a government or regulatory body permitting a company to manufacture, market, or sell a product or service in a specific jurisdiction. Regulatory approvals — including drug approvals (FDA, EMA), financial service licences (FCA, MAS), telecommunications licences, and environmental permits — are recognised as contract-based intangible assets in purchase price allocations under IFRS 3 and ASC 805 when they arise from contractual or legal rights.

The portfolio of drug candidates at various stages of research, development, and regulatory approval within a pharmaceutical or biotechnology company. The pharma pipeline is a critical intangible asset, with each compound's value dependent on its probability of regulatory approval, expected market size, patent protection remaining, and development costs to completion.

An actuarial valuation methodology used to value life insurance companies, representing the present value of future profits from the existing book of insurance policies (the value of in-force business) plus the adjusted net asset value of the company. Embedded value is the standard valuation framework for life insurers and is analogous to the net asset value plus intangible asset value approach used in other industries.

An economic model built around digital platforms that create value by facilitating exchanges between two or more user groups. Platform businesses derive the majority of their enterprise value from intangible assets including network effects, proprietary algorithms, user data, and brand trust.