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Related Concept Videos

Oral Drug Delivery Systems: Introduction01:23

Oral Drug Delivery Systems: Introduction

Oral drug delivery is the most common route of administration due to its convenience, cost-effectiveness, and high patient compliance. It enables precise formulation to ensure proper drug dosage and bioavailability. The development of oral dosage forms considers drug properties such as solubility, stability, and absorption to optimize therapeutic efficacy.Tablets, capsules, liquids, and chewable formulations enhance drug stability, mask undesirable tastes, and improve patient experience.
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
Drug Nomenclature01:17

Drug Nomenclature

During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that the same...

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Related Experiment Video

Updated: Jun 23, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Trends In Authorized Generic Drug Launches And Their Effects On Competition In Oral-Solid Drug Markets In The US,

Keith M Drake1, Gered Dunne2, Aime Mason3

  • 1Keith M. Drake (kdrake@gma-us.com), Greylock McKinnon Associates, Hanover, New Hampshire.

Health Affairs (Project Hope)
|June 2, 2025
PubMed
Summary
This summary is machine-generated.

Authorized generics, brand-name drugs sold as generics, can lower prices for pharmacies. However, their recent decline, possibly due to litigation settlements, may impact competition and drug costs.

Related Experiment Videos

Last Updated: Jun 23, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Area of Science:

  • Pharmaceutical Economics
  • Drug Pricing and Competition

Background:

  • An authorized generic is a brand manufacturer's drug marketed as a generic.
  • It represents the primary competition for the first traditional generic entrant during the 180-day exclusivity period.
  • Brand manufacturers can use authorized generics as leverage in negotiations for delayed generic entry.

Purpose of the Study:

  • To investigate the competitive effects of authorized generics on the pharmaceutical market.
  • To analyze the impact of authorized generics on generic drug prices.
  • To examine trends in authorized generic launches and their potential causes.

Main Methods:

  • Analysis of data for 146 oral-solid drugs with first generic entry between 2016-2023.
  • Examination of on-invoice prices paid by pharmacies for new generics.
  • Assessment of trends in authorized generic launches and patent litigation settlements.

Main Results:

  • Authorized generics were associated with a 13-18% decrease in on-invoice prices for new generics.
  • Authorized generic launches have significantly declined in recent years.
  • No-authorized-generic agreements in patent litigation settlements may explain this decline.

Conclusions:

  • Authorized generics can exert downward pressure on generic drug prices.
  • The decrease in authorized generic launches may reduce competition.
  • Revisiting no-authorized-generic agreements in patent litigation could benefit drug purchasers.