FDA Approval of Zituvio for Type 2 Diabetes

V Abishek; Muskan; Saurabh Srivastava; PBN Prasad; Sandeep Kumar

doi:10.2174/012210299X286824240722042737

ISSN: 2210-299X
E-ISSN: 2210-3007

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oa FDA Approval of Zituvio for Type 2 Diabetes
Authors: V Abishek¹, Muskan², Saurabh Srivastava^1,3, PBN Prasad⁴ and Sandeep Kumar¹
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¹ Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research- Hyderabad, Balanagar, Hyderabad, Telangana- 500037, India; ² Department of Pharmaceutics, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, U.T. – 160014, India; ³ Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research- Hyderabad, Balanagar, Hyderabad, Telangana- 500037, India; ⁴ Former Affiliation-Central Drugs Standard Control Organization, Govt of India, New Delhi, India
Source: Current Indian Science, Volume 2, Issue 1, Jan 2024, e2210299X286824
DOI: https://doi.org/10.2174/012210299X286824240722042737
- Received: 13 Mar 2024
- Accepted: 04 Jul 2024
- Available online: 24 Jul 2024

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References

Diabetes.2023Available from:https://www.who.int/ news-room/fact-sheets/detail/diabetes(accessed on 12-7-2024)
ScottL.J. Sitagliptin: a review in type 2 diabetes.Drugs201777220922410.1007/s40265‑016‑0686‑928078647
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Highlights of prescribing information of zituvio.Available from:https: //www.accessdata.fda.gov/drugsatfda_docs/label/2023/211566s000lbl.pdf(accessed on 12-7-2024)
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.Available from:https://www.accessdata.fda.gov/scripts/ cder/ob/patent_info.cfm?Product_No=003&Appl_No=211566&Appl_type=N(accessed on 12-7-2024)
Highlights of prescribing information of januvia.2022Available from:https: //www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf(accessed on 12-7-2024)
U.S. District Court Rules In Favor of Merck in Sitagliptin Phosphate Patent Lawsuit.2022Available from:https://www.merck.com/ news/u-s-district-court-rules-in-favor-of-merck-in-sitagliptin-phosphate-patent-lawsuit/#:~:text=The%20first%2C%20U.S.%20Patent%20No.%207%2C326%2C708%2C%20covers%20the%20dihydrogen%20phosphate%20salt%20of%20sitagliptin%20and%20is%20set%20to%20expire%20on%20Nov.%2024%2C%202026%2C%20with%20pediatric%20exclusivity%20extending%20to%20May%2024%2C%202027(accessed on 12-7-2024)
U.S. patentAvailable from:https://image-ppubs.uspto.gov/ dirsearch-public/print/downloadPdf/7326708(accessed on 12-7-2024)
Zydus receives USFDA approval for ZITUVIO™ to treat adult patients with type 2 diabetes mellitus.Available from:https://www. prnewswire.com/news-releases/zydus-receives-usfda-approval-for-zituvio-to-treat-adult-patients-with-type-2-diabetes-mellitus-301963298.html#:~:text=According%20to%20IQVIA%E2%84%A2%C2%A0(MAT%20Aug%2D2023)%2C%20U.S.%20market%20for%20DPP%2DIV%20inhibitors%20and%20its%20combinations%20is%20US%24%2010%20bn(accessed on 12-7-2024)
Section 3(d) of Indian Patents Act 1970: significance and interpretation.1970Available from:https://www.lexology.com/ library/detail.aspx?g=3f92413f-107c-4886-aca7-24633a341e22#:~:text=Section%203(d)%20specifically%20disallows,such%20substances%20having%20incremental%20innovations.(accessed on 12-7-2024)

/content/journals/cis/10.2174/012210299X286824240722042737

FDA Approval of Zituvio for Type 2 Diabetes

Curr. Indian Sci. 2, e2210299X286824 (2024); https://doi.org/10.2174/012210299X286824240722042737

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oa FDA Approval of Zituvio for Type 2 Diabetes

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