Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

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...
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,...
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...
Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Reply to 'Methodological concerns and a lack of evidence for reforming regulatory exclusivities for pharmaceuticals'.

Nature biotechnology·2026
Same author

Tear down the wall: why requiring the FDA and the PTO to share information will improve the decision-making of both agencies.

Journal of law and the biosciences·2026
Same author

The New Clinical Investigation exclusivity: a substantial source of monopoly time for brand drugs.

Nature biotechnology·2025
Same author

Paucity of intellectual property rights information in the US biologics system a decade after passage of the Biosimilars Act.

PLoS medicine·2024
Same author

NIH Licensing Would Benefit from Free-Market Provisions.

The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics·2024
Same author

Leading with the trailing edge: facilitating patient choice for insulin products.

Journal of law and the biosciences·2023

Related Experiment Video

Updated: Jun 12, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Modification patents across multiple NDAs in pharmaceutical protections.

Robin Feldman1, Ramy Alsaffar1, Tanziuzzaman Sakib1

  • 1Center for Innovation (C4i), University of California Law, SanFrancisco, San Francisco, CA 94102, USA.

Health Affairs Scholar
|June 11, 2026
PubMed
Summary

Pharmaceutical companies use modification patents to extend drug exclusivity, adding an average of 10.9 years of protection. These patents significantly delay generic drug entry, impacting market competition and patient access.

Keywords:
drugdrug approval processdrug industrydrugseconomicsgenerichealth policylegislationnew drug approval processpatents as topicpharmaceutical

More Related Videos

Multi-target Parallel Processing Approach for Gene-to-structure Determination of the Influenza Polymerase PB2 Subunit
22:10

Multi-target Parallel Processing Approach for Gene-to-structure Determination of the Influenza Polymerase PB2 Subunit

Published on: June 28, 2013

Related Experiment Videos

Last Updated: Jun 12, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Multi-target Parallel Processing Approach for Gene-to-structure Determination of the Influenza Polymerase PB2 Subunit
22:10

Multi-target Parallel Processing Approach for Gene-to-structure Determination of the Influenza Polymerase PB2 Subunit

Published on: June 28, 2013

Area of Science:

  • Pharmaceutical Sciences
  • Intellectual Property Law
  • Health Economics

Background:

  • Pharmaceutical companies utilize modification patents to extend market exclusivity for drugs.
  • Existing research lacks a comprehensive analysis of these patents across multiple New Drug Applications (NDAs).
  • Current regulatory initiatives focus on modification patents, necessitating a deeper understanding of their impact.

Purpose of the Study:

  • To comprehensively examine modification patents for Active Pharmaceutical Ingredients (APIs) across multiple NDAs.
  • To investigate how these patents extend drug protection periods.
  • To assess the impact of modification patents on generic drug entry and market competition.

Main Methods:

  • Analysis of 1028 modification patents categorized by type (chemical, formulation, treatment, device/agent).
  • Tabulation of extended patent protection time, correlation with new NDAs, and litigation data.
  • Examination of market outcomes for drugs with generic approvals or expiring primary patents.

Main Results:

  • Modification patents extended drug protection by an average of 10.9 years.
  • A median of 2.3 years of effective additional protection was provided before generic entry.
  • 89% of drugs experienced extended protection, 58% linked to new NDAs, and 70% involved in Paragraph IV litigation.

Conclusions:

  • Modification patenting warrants reconsideration regarding societal resource allocation.
  • Regulatory and legislative reforms, such as a "one-and-done" policy, may be necessary.
  • Restricting certain types of modification patents could foster greater generic competition.