`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence
`Evaluations
`
`Home (index.cfm?resetfields=1) | Back to Search Results
`
`Product Details for ANDA 205981
`Collapse All
`
`SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN
`HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
`500MG;EQ 5MG BASE
`Marketing Status: Prescription
`
`Active Ingredient: METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
`Proprietary Name: SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
`Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
`Strength: 500MG;EQ 5MG BASE
`Reference Listed Drug: No
`Reference Standard: No
`TE Code: AB
`Application Number: A205981
`Product Number: 001
`Approval Date: Jul 31, 2023
`Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?
`Product_No=001&Appl_No=205981&Appl_type=A)
`
`SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN
`HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
`1GM;EQ 2.5MG BASE
`Marketing Status: Prescription
`
`Active Ingredient: METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
`Proprietary Name: SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
`Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
`
`Novo Nordisk Exhibit 2405
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Strength: 1GM;EQ 2.5MG BASE
`Reference Listed Drug: No
`Reference Standard: No
`TE Code: AB
`Application Number: A205981
`Product Number: 002
`Approval Date: Jul 31, 2023
`Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?
`Product_No=002&Appl_No=205981&Appl_type=A)
`
`SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN
`HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
`1GM;EQ 5MG BASE
`Marketing Status: Prescription
`
`Active Ingredient: METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
`Proprietary Name: SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
`Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
`Strength: 1GM;EQ 5MG BASE
`Reference Listed Drug: No
`Reference Standard: No
`TE Code: AB
`Application Number: A205981
`Product Number: 003
`Approval Date: Jul 31, 2023
`Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
`Marketing Status: Prescription
`Patent and Exclusivity Information (patent_info.cfm?
`Product_No=003&Appl_No=205981&Appl_type=A)
`
`Novo Nordisk Exhibit 2405
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`