Patents and Patent Expiry Impact on Innovation and Market Competition in the Drug Development Process - A Real-World Case Study of the Antidiabetic Drug Januvia® (Sitagliptin)

Nandhini A; S. Nagalakshmi

doi:10.36948/ijfmr.2026.v08i04.80928

Patents and Patent Expiry Impact on Innovation and Market Competition in the Drug Development Process - A Real-World Case Study of the Antidiabetic Drug Januvia® (Sitagliptin)

Author(s)	Ms. Nandhini A, S. Nagalakshmi
Country	India
Abstract	Intellectual Property (IP) protection is central to pharmaceutical innovation, providing exclusivity that enables recovery of research and development investments while delaying generic competition. This study explores the critical role of patents across the drug development lifecycle using a real-world case study of Januvia® (Sitagliptin Phosphate Monohydrate), the first DPP-4 inhibitor approved by the USFDA for the treatment of Type 2 Diabetes Mellitus. The analysis encompasses various patent types like compound, formulation, process, polymorph, and methods of use, and evaluates their impact on regulatory timelines, market exclusivity, and pricing strategies. Through comprehensive literature and patent database reviews, this study traces Januvia's development from target identification to post-marketing surveillance and eventual generic entry, highlighting key patents and their expiry timelines. It further discusses the implications of the Hatch-Waxman Act, patent term extensions, and Paragraph IV certifications in shaping market dynamics. Findings demonstrate how strategic patenting extends market control beyond primary patent expiry, influencing competition and access. The case of Januvia underscores the dual nature of patents: fostering innovation while potentially delaying affordability. A balanced regulatory and IP framework is essential to encourage drug discovery while ensuring timely availability of generics for broader public health benefits.
Keywords	Diabetes Mellitus, IP patent, Regulatory Framework, Drug Development Process, Januvia.
Field	Medical / Pharmacy
Published In	Volume 8, Issue 4, July-August 2026
Published On	2026-08-16
DOI	https://doi.org/10.36948/ijfmr.2026.v08i04.80928

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Patents and Patent Expiry Impact on Innovation and Market Competition in the Drug Development Process - A Real-World Case Study of the Antidiabetic Drug Januvia® (Sitagliptin)

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