`
`Drug
`
`Active Ingredient
`
`Company
`
`U.S. Launch Date [2]
`
`Method of Administration
`Vial
`Pen
`
`Strength [3]
`
`Fast-Acting [4]
`Admelog SoloSTAR
`Admelog Vial
`Apidra Vial
`Apidra OptiClik
`Apidra SoloSTAR
`Humalog Reusable Pen
`Humalog Vial
`Humalog Pen
`Humalog KwikPen
`Humalog Jr. KwikPen
`Humulin R Pen
`Humulin R Vial
`Humulin R KwikPen
`Novolog Vial
`Novolog Pen
`Novolog FlexPen
`
`Insulin Lispro
`Insulin Lispro
`Insulin Glulisine
`Insulin Glulisine
`Insulin Glulisine
`Insulin Lispro
`Insulin Lispro
`Insulin Lispro
`Insulin Lispro
`Insulin Lispro
`Insulin Human
`Insulin Human
`Insulin Human
`Insulin Aspart
`Insulin Aspart
`Insulin Aspart
`
`Intermediate-Acting [5]
`Humalog Pen Mix 75/25
`Humalog Mix 75/25 Vial
`Humalog Pen Mix 50/50
`Humalog Mix 50/50 Vial
`Humalog KwikPen 50/50
`Humalog KwikPen 75/25
`Novolog FlexPen Mix 70/30
`Novolog Mix 70/30 Vial
`
`Insulin Lispro
`Insulin Lispro
`Insulin Lispro
`Insulin Lispro
`Insulin Lispro
`Insulin Lispro
`Insulin Aspart
`Insulin Aspart
`
`Sanofi Aventis
`Sanofi Aventis
`Sanofi Aventis
`Sanofi Aventis
`Sanofi Aventis
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Novo Nordisk
`Novo Nordisk
`Novo Nordisk
`
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Eli Lilly
`Novo Nordisk
`Novo Nordisk
`
`March 2018
`March 2018
`January 2006
`February 2006
`April 2009
`August 1996
`August 1996
`December 1998
`January 2008
`September 2017
`July 1983
`July 1983
`March 2016
`August 2001
`September 2001
`February 2003
`
`February 2000
`December 2000
`February 2006
`November 2006
`January 2008
`January 2008
`September 2002
`February 2003
`
`X
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`
`X
`X
`X
`
`X
`X
`X
`X
`
`X
`
`X
`X
`
`X
`
`X
`
`X
`X
`X
`
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`300U/3ML
`1 00U/ML and 200U/ML
`100U/ML
`100U/ML
`1 00U/ML and 500U/ML
`500U/ML
`100U/ML
`300U/3ML
`100U/ML
`
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`
`Sanofi Exhibit 2186.001
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`Select Injectable Insulin Drugs Approved by the FDA in the U.S. [1]
`
`Drug
`
`Active Ingredient
`
`Company
`
`U.S. Launch Date [2]
`
`Method of Administration
`Vial
`Pen
`
`Strength [3]
`
`Long-Acting
`Basaglar KwikPen
`Humulin U Vial [6]
`Lantus Vial
`Lantus OptiClik
`Lantus SoloST AR
`Levemir FlexPen
`Levemir Vial
`Levemir FlexTouch
`Toujeo SoloSTAR
`Toujeo Max SoloSTAR
`Tresiba FlexTouch
`
`Insulin Glargine
`Insulin Human
`Insulin Glargine
`Insulin Glargine
`Insulin Glargine
`Insulin Detemir
`Insulin Detemir
`Insulin Detemir
`Insulin Glargine
`Insulin Glargine
`Insulin Degludec
`
`Eli Lilly
`Eli Lilly
`Sanofi Aventis
`Sanofi Aventis
`Sanofi Aventis
`Novo Nordisk
`Novo Nordisk
`Novo Nordisk
`Sanofi Aventis
`Sanofi Aventis
`Novo Nordisk
`
`December 2016
`July 1987
`April 2001
`January 2005
`July 2007
`February 2006
`February 2006
`May 2014
`March 2015
`April 2018
`November 2015
`
`X
`X
`
`X
`
`X
`
`X
`X
`X
`
`X
`X
`X
`X
`
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`100U/ML
`300U/ML
`300U/ML
`1 00U/ML and 200U/ML
`
`Source: IMS Health; U.S. Food & Drug Administration
`Note:
`[1] Drugs included are either sold by Sanofi, part of the Humalog Franchise, Humulin U Vial, Novolog Mix 70/30 Vial, had over $350,000,000 in sales in 2018, or had an
`accompanying administration with over $350,000,000 in sales in 2018.
`[2] Launch date is defined as the first month of IMS data with non-zero sales or prescriptions. For drugs launched prior to January 2001, launch date is defined as the
`date listed in the Product variable in the IMS data.
`[3] Strength is measured in insulin units per milliliter.
`[4] other fast-acting drugs in the IMS data are Fiasp FlexTouch, Fiasp Vial, Human Insulin R Vial, Humulin BR Vial, Novolin R lnnolet Pen, Novolin R Pen, Novolin R
`Prefilled Pen, Novolin R Vial, Relion R Vial, Velosulin Human BR Vial, and Velosulin RONA BR Vial.
`[5] other intermediate-acting drugs in the IMS data are Human Insulin 70/30 Pen, Human Insulin 70/30 Vial, Human Insulin N Pen, Human Insulin N Vial, Humulin 50/50
`Vial, Humulin 70/30 KwikPen, Humulin 70/30 Pen, Humulin 70/30 Pen (Unspecified), Humulin 70/30 Vial, Humulin L Vial, Humulin N KwikPen, Humulin N Pen,
`Humulin N Pen (Unspecified), Humulin N Vial, Mixtard Human 70/30 Vial, Novolog Mix 70/30 Pen, Novolin 70/30 FlexPen, Novolin 70/30 lnnolet Pen, Novolin 70/30
`Pen, Novolin 70/30 Prefilled Pen, Novolin 70/30 Vial, Novolin L Vial, Novolin N lnnolet Pen, Novolin N Pen, Novolin N Prefilled Pen, Novolin N Vial, Relion 70/30 Vial,
`Relion N Vial, Relion Novolin 70/30 Vial, and Relion Novolin N Vial.
`[6] Humulin U Vial was discontinued in 2005.
`
`Sanofi Exhibit 2186.002
`Mylan v. Sanofi
`IPR2018-01675
`
`
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