Attachment B-1
`Summary of AED Treatments
`
`Compound
`
`Approval Dates
`Branded
`Generic
`
`Branded Name
`
`Notes
`
`Company
`
`Phenytoin
`
`1/6/1953
`
`9/25/1992
`
`Dilantin
`
`Carbamazepine
`
`3/11/1968
`
`8/14/1986
`
`Tegretol
`
`Tegretol-XR
`
`[A]
`
`[B]
`
`[C]
`
`Pfizer
`
`Novartis
`
`Novartis
`
`Valproates
`
`3/10/1983
`
`2/28/1986
`
`Depakote
`
`[D]
`
`AbbVie
`
`Depakote ER
`
`[E]
`
`AbbVie
`
`Gabapentin
`
`12/30/1993
`
`9/12/2003
`
`Neurontin
`
`[F]
`
`Pfizer
`
`Lamotrigine
`
`12/27/1994
`
`6/21/2006
`
`Lamictal
`
`[G]
`
`GlaxoSmithKline
`
`Lamictal XR
`
`[H]
`
`GlaxoSmithKline
`
`Topamax
`
`[I]
`
`Janssen
`
`Topiramate
`
`12/24/1996
`
`3/27/2009
`
`Trokendi XR
`
`[J]
`
`Supernus
`
`Qudexy XR
`
`[K]
`
`Upsher
`
`Levetiracetam
`
`11/30/1999
`
`11/4/2008
`
`Keppra
`
`[L]
`
`UCB
`
`Keppra XR
`
`[M]
`
`UCB
`
`Approved Indications
`- Control of generalized tonic-clonic (grand mal) and complex partial (psychomotor,
`temporal lobe) seizures
`- Prevention and treatment of seizures occurring during or following neurosurgery
`- Anticonvulsant
`- Treatment of pain associated with true trigeminal neuralgia
`- Anticonvulsant
`- Treatment of pain associated with true trigeminal neuralgia
`- Treatment of manic episodes associated with bipolar disorder
`- Monotherapy and adjunctive therapy in treatment of patients with complex partial
`seizures that occur either in isolation or in association with other types of seizures
`- Prophylaxis of migraine headaches
`- Treatment of acute manic or mixed episodes associated with bipolar disorder
`- prophylaxis of migraine headaches in adults
`- Monotherapy and adjunctive therapy in treatment of adults and children 10 years of age
`or older with complex partial seizures that occur either in isolation or in association with
`other types of seizures
`- Management of postherpetic neuralgia in adults
`- Adjunctive therapy in treatment of partial seizures with and without secondary
`generalization in patients over 12 years of age with epilepsy
`- Adjunctive therapy in treatment of partial seizures in pediatric patients age 3–12 years
`- Adjunctive epilepsy therapy in patients at least 2 years of age for partial seizures,
`primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut
`syndrome
`- Epilepsy monotherapy in patients at least 16 years of age
`- Bipolar disorder in patients at least 18 years of age
`- Adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial onset
`seizures with or without secondary generalization in patients at least 13 years of age
`- Conversion to monotherapy in patients at least 13 years of age with partial seizures who
`are receiving treatment with a single AED
`- Initial monotherapy in patients 10 years of age and older with partial onset or primary
`generalized tonic-clonic seizures
`- Adjunctive therapy for adults and pediatric patients ages 2–16 years with partial onset
`seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and
`older with seizures associated with Lennox-Gastaut syndrome
`- For adults for prophylaxis of migraine headache
`- Partial onset seizure and primary generalized tonic-clonic seizures
`- Lennox-Gastaut Syndrome
`- Partial onset seizures and primary generalized tonic-clonic seizures initial monotherapy
`in patients 10 years of age and older with partial onset or primary generalized tonic-clonic
`seizures
`- Adjunctive therapy in patients 2 years of age and older with partial onset or primary
`generalized tonic-clonic seizures
`- Lennox-Gastaut Syndrome adjunctive therapy in patients 2 years of age and older with
`seizures associated with Lennox-Gastaut syndrome
`- Adjunctive therapy in treatment of partial onset seizures in adults and children 4 years of
`age and older with epilepsy
`- Adjunctive therapy in treatment of myoclonic seizures in adults and adolescents 12 years
`of age and older with juvenile myoclonic epilepsy
`- Adjunctive therapy in treatment of primary generalized tonic-clonic seizures in adults
`and children 6 years of age and older with idiopathic generalized epilepsy
`- Adjunctive therapy in treatment of partial onset seizures in patients at least 16 years of
`age with epilepsy
`
`Attachment B-1
`Page 1 of 2
`
`00001
`
`ARGENTUM Exhibit 1158
`Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`IPR2016-00204
`
`

`

`Compound
`
`Approval Dates
`Branded
`Generic
`
`Branded Name
`
`Notes
`
`Company
`
`Oxcarbazepine
`
`1/14/2000
`
`10/9/2007
`
`Trileptal
`
`Zonisamide
`
`3/27/2000
`
`12/22/2005
`
`Zonegran
`
`[N]
`
`[O]
`
`Novartis
`
`Eisai
`
`Pregabalin
`
`12/30/2004
`
`7/3/2012
`
`Lyrica
`
`[P]
`
`Pfizer
`
`Lacosamide
`
`10/28/2008
`
`Rufinamide
`
`11/14/2008
`
`Vigabatrin
`Ezogabine
`Perampanel
`Eslicarbazepine
`acetate
`
`8/21/2009
`6/10/2011
`10/22/2012
`
`11/8/2013
`
`-
`
`-
`
`-
`-
`-
`
`-
`
`Vimpat
`
`Banzel
`
`Sabril
`Potiga
`Fycompa
`
`Aptiom
`
`[Q]
`
`[R]
`
`[S]
`[T]
`[U]
`
`[V]
`
`UCB
`
`Eisai
`
`Lundbeck
`GlaxoSmithKline
`Eisai
`
`Sunovion
`
`Approved Indications
`- Monotherapy or adjunctive therapy in treatment of partial seizures in adults
`- Monotherapy in treatment of partial seizures in children aged 4 years and above with
`epilepsy
`- Adjunctive therapy in children aged 2 years and above with epilepsy
`- Adjunctive therapy in treatment of partial seizures in adults with epilepsy
`- Management of neuropathic pain associated with diabetic peripheral neuropathy
`- Management of postherpetic neuralgia
`- Adjunctive therapy for adult patients with partial onset seizures
`- Management of fibromyalgia
`- Management of neuropathic pain associated with spinal cord injury
`- Monotherapy or adjunctive therapy in patients with partial onset seizures
`- Injection is indicated as short term replacement when oral administration is not feasible
`- Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4
`years and older and adults
`- Refractory complex partial seizures in adults as adjunctive therapy in patients who have
`responded inadequately to several alternative treatments
`- Adjunctive treatment of partial-onset seizures in patients aged 18 years and older
`- Adjunctive therapy for treatment of partial-onset seizures with or without secondarily
`generalized seizures in patients with epilepsy aged 12 years and older
`- Adjunctive treatment of partial-onset seizures
`
`Notes and sources:
`Ex. 2132: Vellturo Declaration, ¶ 14.
`[A] Ex. 1194: Pfizer Website, Dilantin Label, http://labeling.pfizer.com/showlabeling.aspx?id=544.
`[B] Ex. 1195: FDA Website, Tegretol Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf.
`[C] Ex. 1195: FDA Website, Tegretol Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf.
`[D] Ex. 1196: FDA Website, Depakote Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018723s039lbl.pdf.
`[E] Ex. 1197: FDA Website, Depakote ER Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf.
`[F] Ex. 1198: FDA Website, Neurontin Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf.
`[G] Ex. 1199: FDA Website, Lamictal Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf.
`[H] Ex. 1200: FDA Website, Lamictal XR Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s006lbl.pdf.
`[I] Ex. 1201: FDA Website, Topamax Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020505s038s039,020844s032s034lbl.pdf.
`[J] Ex. 1202: Trokendi XR Website, Trokendi XR Label, http://www.trokendixr.com/hcp/pdfs/trokendi-prescribing-information.pdf.
`[K] Ex. 1203: FDA Website, Qudexy XR Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205122s000lbl.pdf.
`[L] Ex. 1204: FDA Website, Keppra Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021035s078s080,021505s021s024lbl.pdf.
`[M] Ex. 1205: FDA Website, Keppra XR Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022285s001lbl.pdf.
`[N] Ex. 1206: FDA Website, Trileptal Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021014s026,021285s021lbl.pdf.
`[O] Ex. 1207: FDA Website, Zonegran Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf.
`[P] Ex. 1208: Pfizer Website, Lyrica Label, http://labeling.pfizer.com/ShowLabeling.aspx?id=561#section-1.
`[Q] Ex. 1166: Vimpat (lacosamide) Label, 10/28/2008.
`Ex. 1167: Vimpat (lacosamide) Label, 8/29/2014.
`[R] Ex. 1209: FDA Website, Banzel label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021911s005lbl.pdf.
`[S] Ex. 1210: FDA Website, Sabril Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020427s000lbl.pdf.
`[T] Ex. 1211: FDA Website, Potiga Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf.
`[U] Ex. 1212: FDA Website, Fycompa Label, http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202834lbl.pdf.
`[V] Ex. 1213: U.S. National Library of Medicine Website, Aptiom Label, http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d0c9554-eaeb-4694-8089-00133fcadce3.
`
`Attachment B-1
`Page 2 of 2
`
`00002
`
`

`

`Attachment B-2
`Vimpat Net Sales and TRx in the United States
`
`Year
`2009
`2010
`2011
`2012
`2013
`2014
`2015
`2016
`Total
`
`Net Sales
`
`41.5$
`
`126.1$
`
`217.9$
`
`315.9$
`
`407.0$
`
`443.5$
`
`568.3$
`
`321.1$
`
`2,441.3$
`
`TRx
`83,618
`311,984
`502,258
`659,595
`819,692
`972,567
`171,842
`N/A
`3,521,556
`
`Notes and sources:
`Figures are in millions of $U.S.
`Net sales are from Ex. 2174: Vimpat Sales Data, at 2.
`Net sales data are from May 2009 to June 2016.
`TRx figures are from Ex. 2136: AED Market Basket, at 2.
`2015 TRx figures include only January - February.
`
`Attachment B-2
`Page 1 of 1
`
`00003
`
`

`

`Attachment B-3
`Present Value of Vimpat Sales To Date
`
`Description
`Vimpat net sales
`Gross margin
`Gross profit
`Operating margin
`Operating profit
`Present value factor
`Present value
`Cumulative total present value
`
`Notes
`[A]
`[B]
`[C]
`[D]
`[E]
`[F]
`[G]
`[H]
`
`2009
`
`41.5$
`85%
`
`35.3$
`75%
`
`31.1$
`0.970
`
`30.2$
`
`30.2$
`
`2010
`
`126.1$
`85%
`
`107.2$
`75%
`
`94.6$
`0.896
`
`84.7$
`
`115.0$
`
`2011
`
`217.9$
`85%
`
`185.2$
`75%
`163.4$
`
`0.811
`
`132.5$
`
`247.5$
`
`268.5$
`
`2012
`
`315.9$
`85%
`
`75%
`236.9$
`
`0.734
`
`173.8$
`
`421.3$
`
`2013
`407.0$
`
`85%
`
`346.0$
`75%
`305.3$
`
`0.664
`
`202.7$
`
`624.0$
`
`2014
`443.5$
`
`85%
`
`377.0$
`75%
`332.6$
`
`0.601
`
`199.9$
`
`823.9$
`
`2015
`
`568.3$
`85%
`
`483.1$
`75%
`426.2$
`
`0.544
`
`231.8$
`
`1,055.6$
`
`2016
`
`321.1$
`85%
`
`272.9$
`75%
`240.8$
`
`0.505
`
`121.5$
`
`1,177.1$
`
`Notes and sources:
`Figures are in millions of $U.S.
`[A] Attachment B-2.
`Net sales data are from May 2009 to June 2016.
`[B] Gross margin estimated to be 85% of net sales.
`[C] = [A] x [B].
`[D] Operating margin estimated to be 75% of net sales.
`[E] = [A] x [D].
`[F] Present value factors use mid-period convention, discounting to Vimpat launch on 5/26/2009.
`2009 present value factor as of 9/12/2009 midway between Vimpat launch on 5/26/2009 and the end of the year.
`Calculated using discount factor of 10.5%, consistent with academic literature (though a rate could reasonably be even higher).
`2016 Q2 present value factor as of 3/31/2016, midway between 12/31/2015 and 6/30/2016.
`[G] = [E] × [F].
`[H] = Cumulative sum of [G].
`
`Parameters:
`Discount factor for net present value
`Net present value date (Vimpat launch)
`
`10.5%
`5/26/2009
`
`Attachment B-3
`Page 1 of 1
`
`00004
`
`

`

`Attachment C-1
`AED U.S. Prescriptions Associated with Epilepsy Indications from Vellturo Declaration
`
`UCB-Defined AED Products
`Aptiom
`Banzel
`Depakote
`
`Depakote-ER
`
`Dilantin
`Fycompa
`Keppra-IR
`
`Keppra-XR
`
`Lamictal
`
`Lamictal-XR
`Lyrica
`Neurontin
`Potiga
`Sabril
`Tegretol
`
`Tegretol-XR
`
`Topamax
`Trokendi XR
`Trileptal
`Vimpat - taken as 100%
`Zonegran
`Topiramate ER
`Qudexy XR
`Lamotrigine ODT
`Active Pac / Gabapen
`Total branded
`Total generic
`Grand total
`
`Branded / Generic
`Branded
`Branded
`Branded
`Generic
`Branded
`Generic
`Branded
`Generic
`Branded
`Branded
`Generic
`Branded
`Generic
`Branded
`Generic
`Branded
`Generic
`Branded
`Branded
`Generic
`Branded
`Branded
`Branded
`Generic
`Branded
`Generic
`Branded
`Generic
`Branded
`Branded
`Generic
`Branded
`Branded
`Generic
`Branded
`Branded
`Branded
`Branded
`
`Compound
`Eslicarbazepine acetate
`Rufinamide
`Valproates
`Valproates
`Valproates
`Valproates
`Phenytoin
`Phenytoin
`Perampanel
`Levetiracetam
`Levetiracetam
`Levetiracetam
`Levetiracetam
`Lamotrigine
`Lamotrigine
`Lamotrigine
`Lamotrigine
`Pregabalin
`Gabapentin
`Gabapentin
`Ezogabine
`Vigabatrin
`Carbamazepine
`Carbamazepine
`Carbamazepine
`Carbamazepine
`Topiramate
`Topiramate
`Topiramate
`Oxcarbazepine
`Oxcarbazepine
`Lacosamide
`Zonisamide
`Zonisamide
`Topiramate
`Topiramate
`Lamotrigine
`Gabapentin
`
`2007 Apr–Dec
`
`-
`
`-
`
`2,470,031
`
`205,136
`
`1,623,762
`
`-
`
`1,324,361
`
`2,909,752
`
`-
`
`2,749,793
`
`-
`
`-
`
`-
`
`2,373,167
`
`19,927
`
`-
`
`-
`
`246,397
`49,981
`
`
`562,477
`
`-
`
`-
`
`206,490
`
`1,301,915
`
`562,053
`
`372,682
`
`2,354,454
`
`-
`
`-
`
`1,411,228
`
`145,356
`
`-
`
`58,649
`
`369,345
`
`-
`
`-
`
`-
`
`-
`
`15,430,365
`
`5,886,590
`
`21,316,955
`
`2008
`-
`
`
`-
`2,395,637
`
`694,528
`
`2,206,333
`
`1,138
`
`1,537,122
`
`3,737,603
`
`
`-
`4,074,242
`
`267,524
`
`14,067
`
`
`-
`2,479,221
`
`539,815
`
`
`-
`
`-
`391,579
`
`55,485
`
`820,089
`
`
`-
`
`-
`236,952
`
`1,702,783
`
`723,866
`
`480,747
`
`3,237,126
`
`
`-
`
`-
`524,118
`
`918,225
`
`
`-
`64,295
`
`514,869
`
`
`-
`
`-
`
`-
`
`-
`
`17,940,043
`
`9,677,322
`
`27,617,365
`
`2009
`-
`
`
`39,144
`
`448,952
`
`1,725,242
`
`702,096
`
`731,946
`
`1,336,084
`
`3,550,487
`
`-
`
`1,121,857
`
`3,328,124
`
`256,602
`
`-
`
`588,461
`
`1,553,933
`
`20,380
`
`-
`
`366,580
`
`49,250
`
`940,047
`
`-
`
`2,737
`
`206,133
`
`1,676,449
`
`537,347
`
`613,506
`
`1,192,570
`
`1,071,073
`
`-
`
`403,223
`
`992,830
`
`83,618
`
`56,735
`
`550,185
`
`-
`
`-
`
`-
`
`-
`
`7,411,770
`
`16,733,822
`
`24,145,592
`
`2010
`-
`
`
`68,765
`
`269,653
`
`1,831,481
`
`293,430
`
`940,794
`
`1,174,912
`
`3,370,705
`
`-
`
`576,284
`
`4,453,067
`
`359,398
`
`-
`
`381,784
`
`1,728,706
`
`117,584
`
`-
`
`345,640
`
`44,028
`
`1,082,478
`
`-
`
`16,342
`
`178,669
`
`1,667,926
`
`335,087
`
`748,133
`
`249,746
`
`1,636,330
`
`-
`
`257,885
`
`1,096,995
`
`311,984
`
`52,124
`
`571,663
`
`-
`
`-
`
`-
`
`-
`
`5,033,316
`
`19,128,279
`
`24,161,595
`
`2011
`-
`
`
`82,660
`
`223,037
`
`1,844,192
`
`194,348
`
`984,487
`
`1,021,795
`
`3,166,627
`
`-
`
`465,305
`
`5,222,054
`
`331,010
`
`39,886
`
`312,756
`
`1,843,963
`
`170,440
`
`-
`
`341,382
`
`32,259
`
`1,226,612
`
`-
`
`29,440
`
`155,180
`
`1,630,542
`
`283,718
`
`743,947
`
`187,730
`
`1,722,786
`
`-
`
`252,302
`
`1,111,644
`
`502,258
`
`46,267
`
`596,219
`
`-
`
`-
`
`-
`
`-
`
`4,631,887
`
`20,132,957
`
`24,764,843
`
`2012
`-
`
`
`86,421
`
`175,856
`
`1,856,602
`
`129,523
`
`1,005,827
`
`889,813
`
`3,013,269
`
`-
`
`368,463
`
`5,912,051
`
`160,311
`
`198,317
`
`244,612
`
`1,965,404
`
`192,617
`
`-
`
`328,105
`
`24,029
`
`1,422,914
`
`5,387
`
`22,102
`
`121,753
`
`1,684,848
`
`252,487
`
`748,138
`
`147,848
`
`1,841,658
`
`-
`
`267,653
`
`1,112,126
`
`659,595
`
`38,817
`
`624,816
`
`-
`
`-
`
`-
`
`-
`
`4,115,391
`
`21,385,970
`
`25,501,361
`
`2013
`-
`
`94,994
`
`
`154,325
`
`1,943,080
`
`109,024
`
`1,046,793
`
`652,827
`
`2,974,633
`
`-
`
`320,220
`
`6,624,941
`
`128,222
`
`258,302
`
`209,236
`
`2,131,576
`
`115,759
`128,375
`
`
`340,588
`
`19,436
`
`1,619,137
`
`13,106
`
`20,149
`
`99,858
`
`1,680,420
`
`233,880
`
`767,258
`
`125,112
`
`2,041,510
`
`4,707
`
`153,252
`
`1,249,954
`
`819,692
`
`33,858
`
`682,748
`
`-
`
`-
`
`-
`
`-
`
`3,648,244
`
`23,148,726
`
`26,796,970
`
`2014
`15,256
`
`
`101,361
`
`135,254
`
`2,012,149
`
`105,535
`
`1,052,987
`
`552,610
`
`2,804,935
`19,424
`
`
`283,468
`
`7,307,462
`
`111,875
`
`322,889
`
`178,573
`
`2,261,356
`
`87,405
`
`215,518
`
`357,764
`
`15,812
`
`1,871,447
`
`7,529
`
`30,313
`
`91,794
`
`1,649,924
`
`219,630
`
`773,736
`
`102,315
`
`2,204,980
`
`50,579
`
`116,092
`
`1,340,245
`
`972,567
`
`30,094
`
`741,854
`
`1,105
`
`82
`-
`
`
`-
`
`3,586,436
`
`24,559,484
`
`28,145,920
`
`2015 Jan–Feb
`
`6,728
`16,888
`
`19,621
`
`321,835
`
`15,581
`
`167,848
`
`81,329
`
`426,742
`
`5,442
`
`41,408
`
`1,223,661
`
`16,894
`
`57,938
`
`26,189
`
`374,510
`
`12,356
`
`40,534
`
`57,893
`
`2,258
`
`320,143
`
`988
`
`2,942
`
`13,710
`
`255,360
`
`34,040
`
`123,714
`
`13,973
`
`364,584
`
`13,117
`
`16,554
`
`221,425
`
`171,842
`
`4,433
`
`123,920
`
`811
`
`311
`
`
`40
`
`0
`575,348
`
`4,022,216
`
`4,597,564
`
`
`Notes and sources:
`Ex. 2136: AED Market Yearly TRx Volume & Market Share - April 2007 – February 2015, at 2.
`Note in source indicates, "Factors have been applied to all products with AED indication."
`Compounds per Attachment B-1.
`
`Attachment C-1
`Page 1 of 1
`
`00005
`
`

`

`Attachment C-2
`Marketplace Sales Shares of AED U.S. Prescriptions Associated with Epilepsy Indications from Vellturo Declaration
`
`UCB-Defined AED Products
`Aptiom
`Banzel
`Depakote
`
`Depakote-ER
`
`Dilantin
`Fycompa
`Keppra-IR
`
`Keppra-XR
`
`Lamictal
`
`Lamictal-XR
`Lyrica
`Neurontin
`Potiga
`Sabril
`Tegretol
`
`Tegretol-XR
`
`Topamax
`Trokendi XR
`Trileptal
`Vimpat - taken as 100%
`Zonegran
`Topiramate ER
`Qudexy XR
`Lamotrigine ODT
`Active Pac / Gabapen
`Total branded
`Total generic
`Grand total
`
`Branded / Generic
`Branded
`Branded
`Branded
`Generic
`Branded
`Generic
`Branded
`Generic
`Branded
`Branded
`Generic
`Branded
`Generic
`Branded
`Generic
`Branded
`Generic
`Branded
`Branded
`Generic
`Branded
`Branded
`Branded
`Generic
`Branded
`Generic
`Branded
`Generic
`Branded
`Branded
`Generic
`Branded
`Branded
`Generic
`Branded
`Branded
`Branded
`Branded
`
`Compound
`Eslicarbazepine acetate
`Rufinamide
`Valproates
`Valproates
`Valproates
`Valproates
`Phenytoin
`Phenytoin
`Perampanel
`Levetiracetam
`Levetiracetam
`Levetiracetam
`Levetiracetam
`Lamotrigine
`Lamotrigine
`Lamotrigine
`Lamotrigine
`Pregabalin
`Gabapentin
`Gabapentin
`Ezogabine
`Vigabatrin
`Carbamazepine
`Carbamazepine
`Carbamazepine
`Carbamazepine
`Topiramate
`Topiramate
`Topiramate
`Oxcarbazepine
`Oxcarbazepine
`Lacosamide
`Zonisamide
`Zonisamide
`Topiramate
`Topiramate
`Lamotrigine
`Gabapentin
`
`2007 Apr–Dec
`0.0%
`0.0%
`11.6%
`1.0%
`7.6%
`0.0%
`6.2%
`13.6%
`0.0%
`12.9%
`0.0%
`0.0%
`0.0%
`11.1%
`0.1%
`0.0%
`0.0%
`1.2%
`0.2%
`2.6%
`0.0%
`0.0%
`1.0%
`6.1%
`2.6%
`1.7%
`11.0%
`0.0%
`0.0%
`6.6%
`0.7%
`0.0%
`0.3%
`1.7%
`0.0%
`0.0%
`0.0%
`0.0%
`72.4%
`27.6%
`100.0%
`
`2008
`0.0%
`0.0%
`8.7%
`2.5%
`8.0%
`0.0%
`5.6%
`13.5%
`0.0%
`14.8%
`1.0%
`0.1%
`0.0%
`9.0%
`2.0%
`0.0%
`0.0%
`1.4%
`0.2%
`3.0%
`0.0%
`0.0%
`0.9%
`6.2%
`2.6%
`1.7%
`11.7%
`0.0%
`0.0%
`1.9%
`3.3%
`0.0%
`0.2%
`1.9%
`0.0%
`0.0%
`0.0%
`0.0%
`65.0%
`35.0%
`100.0%
`
`2009
`0.0%
`0.2%
`1.9%
`7.1%
`2.9%
`3.0%
`5.5%
`14.7%
`0.0%
`4.6%
`13.8%
`1.1%
`0.0%
`2.4%
`6.4%
`0.1%
`0.0%
`1.5%
`0.2%
`3.9%
`0.0%
`0.0%
`0.9%
`6.9%
`2.2%
`2.5%
`4.9%
`4.4%
`0.0%
`1.7%
`4.1%
`0.3%
`0.2%
`2.3%
`0.0%
`0.0%
`0.0%
`0.0%
`30.7%
`69.3%
`100.0%
`
`2010
`0.0%
`0.3%
`1.1%
`7.6%
`1.2%
`3.9%
`4.9%
`14.0%
`0.0%
`2.4%
`18.4%
`1.5%
`0.0%
`1.6%
`7.2%
`0.5%
`0.0%
`1.4%
`0.2%
`4.5%
`0.0%
`0.1%
`0.7%
`6.9%
`1.4%
`3.1%
`1.0%
`6.8%
`0.0%
`1.1%
`4.5%
`1.3%
`0.2%
`2.4%
`0.0%
`0.0%
`0.0%
`0.0%
`20.8%
`79.2%
`100.0%
`
`2011
`0.0%
`0.3%
`0.9%
`7.4%
`0.8%
`4.0%
`4.1%
`12.8%
`0.0%
`1.9%
`21.1%
`1.3%
`0.2%
`1.3%
`7.4%
`0.7%
`0.0%
`1.4%
`0.1%
`5.0%
`0.0%
`0.1%
`0.6%
`6.6%
`1.1%
`3.0%
`0.8%
`7.0%
`0.0%
`1.0%
`4.5%
`2.0%
`0.2%
`2.4%
`0.0%
`0.0%
`0.0%
`0.0%
`18.7%
`81.3%
`100.0%
`
`2012
`0.0%
`0.3%
`0.7%
`7.3%
`0.5%
`3.9%
`3.5%
`11.8%
`0.0%
`1.4%
`23.2%
`0.6%
`0.8%
`1.0%
`7.7%
`0.8%
`0.0%
`1.3%
`0.1%
`5.6%
`0.0%
`0.1%
`0.5%
`6.6%
`1.0%
`2.9%
`0.6%
`7.2%
`0.0%
`1.0%
`4.4%
`2.6%
`0.2%
`2.5%
`0.0%
`0.0%
`0.0%
`0.0%
`16.1%
`83.9%
`100.0%
`
`2013
`0.0%
`0.4%
`0.6%
`7.3%
`0.4%
`3.9%
`2.4%
`11.1%
`0.0%
`1.2%
`24.7%
`0.5%
`1.0%
`0.8%
`8.0%
`0.4%
`0.5%
`1.3%
`0.1%
`6.0%
`0.0%
`0.1%
`0.4%
`6.3%
`0.9%
`2.9%
`0.5%
`7.6%
`0.0%
`0.6%
`4.7%
`3.1%
`0.1%
`2.5%
`0.0%
`0.0%
`0.0%
`0.0%
`13.6%
`86.4%
`100.0%
`
`2014
`0.1%
`0.4%
`0.5%
`7.1%
`0.4%
`3.7%
`2.0%
`10.0%
`0.1%
`1.0%
`26.0%
`0.4%
`1.1%
`0.6%
`8.0%
`0.3%
`0.8%
`1.3%
`0.1%
`6.6%
`0.0%
`0.1%
`0.3%
`5.9%
`0.8%
`2.7%
`0.4%
`7.8%
`0.2%
`0.4%
`4.8%
`3.5%
`0.1%
`2.6%
`0.0%
`0.0%
`0.0%
`0.0%
`12.7%
`87.3%
`100.0%
`
`2015 Jan–Feb
`0.1%
`0.4%
`0.4%
`7.0%
`0.3%
`3.7%
`1.8%
`9.3%
`0.1%
`0.9%
`26.6%
`0.4%
`1.3%
`0.6%
`8.1%
`0.3%
`0.9%
`1.3%
`0.0%
`7.0%
`0.0%
`0.1%
`0.3%
`5.6%
`0.7%
`2.7%
`0.3%
`7.9%
`0.3%
`0.4%
`4.8%
`3.7%
`0.1%
`2.7%
`0.0%
`0.0%
`0.0%
`0.0%
`12.5%
`87.5%
`100.0%
`
`Notes and sources:
`Ex. 2136: AED Market Yearly TRx Volume & Market Share - April 2007 – February 2015, at 2.
`Note in source indicates, "Factors have been applied to all products with AED indication."
`Compounds per Attachment B-1.
`
`Attachment C-2
`Page 1 of 1
`
`00006
`
`

`

`Attachment C-3
`Vimpat Share of Epilepsy Prescriptions
`
`Segment
`
`Vimpat prescriptions divided by all epilepsy prescriptions
`Vimpat epilepsy share of use
`Vimpat share of epilepsy prescriptions
`
`Notes
`
`[A]
`[B]
`[C]
`
`2009
`
`0.3%
`54.0%
`0.2%
`
`2010
`
`1.3%
`54.0%
`0.7%
`
`2011
`
`2.0%
`54.0%
`1.1%
`
`2012
`
`2.6%
`54.0%
`1.4%
`
`2013
`
`3.1%
`54.0%
`1.7%
`
`2014
`
`3.5%
`54.0%
`1.9%
`
`2015 Jan–Feb
`
`3.7%
`54.0%
`2.0%
`
`Notes and sources:
`[A] Attachment C-2.
`[B] = 100% - 46% = 54% on-label use.
`46% of anticonvulsant drug use is estimated to be off-label. See:
`Ex. 1172: Radley, David C., Stan N. Finkelstein, Randall S. Stafford (2006), "Off-label Prescribing Among Office-Based Physicians," Archives of Internal Medicine," 166(9): 1021-1026, at 1024.
`[C] = [A] × [B].
`
`Attachment C-3
`Page 1 of 1
`
`00007
`
`

`

`Attachment C-4
`AED U.S. Prescriptions Associated with Epilepsy Indications and All
`
`Epilepsy Use
`Prescriptions for
`2012–2015 Feb
`[A]
`23,336,423
`11,396,159
`10,251,839
`8,750,549
`8,184,021
`6,912,692
`5,295,175
`4,477,301
`2,280,540
`2,623,696
`1,084,350
`299,664
`75,506
`27,009
`24,866
`21,984
`85,041,775
`
`Share
`[B]
`27.4%
`13.4%
`12.1%
`10.3%
`9.6%
`8.1%
`6.2%
`5.3%
`2.7%
`3.1%
`1.3%
`0.35%
`0.09%
`0.03%
`0.03%
`0.03%
`100.0%
`
`Compound
`
`Levetiracetam
`Phenytoin
`Valproates
`Carbamazepine
`Lamotrigine
`Topiramate
`Gabapentin
`Oxcarbazepine
`Zonisamide
`Lacosamide
`Pregabalin
`Rufinamide
`Vigabatrin
`Ezogabine
`Perampanel
`Eslicarbazepine acetate
`Total
`
`Notes and sources:
`[A] Attachment C-1.
`[B] Shares based on [A].
`
`Attachment C-4
`Page 1 of 1
`
`00008
`
`

`

`Attachment C-5
`Chart of AED U.S. Prescriptions Associated with Epilepsy Indications, by Compound for 2012–February 2015
`
`Compound
`
`Attachment C-5
`Page 1 of 1
`
`25,000,000
`
`20,000,000
`
`15,000,000
`
`TRx
`
`10,000,000
`
`5,000,000
`
`0
`
`Notes and sources:
`Attachment C-4.
`
`00009
`
`

`

`Attachment C-6
`Chart of AED U.S. Prescriptions Associated with All Uses, by Compound for 2012–February 2015
`
`Notes and sources:
`Ex. 1170: McDuff Trial Testimony, at 1073:7-18; Ex. 1171: McDuff Trial Demonstratives (DDX-415).
`
`Attachment C-6
`Page 1 of 1
`
`00010
`
`

`

`Attachment D-1
`AED Marketing Spend by Category, 2009-2014
`
`AED
`
`Lyrica
`Vimpat
`Depakote ER
`Gralise
`Lamictal XR
`Lamictal
`Lamictal ODT
`Trokendi XR
`Keppra XR
`Banzel
`Aptiom
`Fycompa
`Sabril
`Topamax
`Depakote
`Potiga
`Neurontin
`Keppra
`Qudexy XR
`Tegretol XR
`Trileptal
`Zonegran
`Dilantin
`Total
`
`Total Marketing Spend
`Journal Direct-to-
`Consumer Meetings
`
`21.34$
`996.86
`$
`50.35
`$
`0.67
`$
`10.86
`$
`
`4.04$
`
`-$
`-
`$
`1.48
`$
`
`1.16$
`0.60
`$
`3.53
`$
`
`1.25$
`-
`$
`1.49
`$
`
`1.10$
`-
`$
`0.72
`$
`
`0.79$
`-
`$
`0.68
`$
`
`0.30$
`0.10
`$
`0.48
`$
`
`0.09$
`-
`$
`0.52
`$
`
`0.80$
`0.06
`$
`1.15
`$
`
`1.87$
`0.45
`$
`1.23
`$
`
`1.49$
`0.28
`$
`0.79
`$
`
`0.01$
`-
`$
`1.72
`$
`
`0.05$
`-
`$
`0.27
`$
`
`-$
`-
`$
`0.08
`$
`
`-$
`-
`$
`0.17
`$
`
`-$
`-
`$
`0.68
`$
`
`-$
`0.02
`$
`-
`$
`
`-$
`-
`$
`-
`$
`
`-$
`-
`$
`0.52
`$
`
`-$
`-
`$
`-
`$
`
`-$
`-
`$
`0.29
`$
`
`0.06$
`0.01
`$
`-
`$
`
`34.35$
`999.05
`$
`77.01
`$
`
`Contacts
`
`315.11$
`
`51.15$
`
`39.88$
`
`33.31$
`
`19.76$
`
`16.86$
`
`15.79$
`
`12.79$
`
`10.47$
`
`7.90$
`
`5.96$
`
`4.87$
`
`5.42$
`
`4.85$
`
`4.26$
`
`3.80$
`
`2.33$
`
`2.95$
`
`1.74$
`
`0.33$
`
`0.58$
`
`0.24$
`
`0.26$
`
`560.61$
`
`Total
`1,383.66$
`
`66.72
`$
`41.36
`$
`38.60
`$
`22.50
`$
`18.68
`$
`17.26
`$
`13.67
`$
`11.08
`$
`9.91
`$
`9.51
`$
`7.43
`$
`7.15
`$
`5.17
`$
`4.34
`$
`3.97
`$
`3.01
`$
`2.97
`$
`1.74
`$
`0.85
`$
`0.58
`$
`0.53
`$
`0.33
`$
`
`1,671.02$
`
`Contacts
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`13
`12
`14
`15
`16
`18
`17
`19
`21
`20
`23
`22
`n/a
`
`Rank
`Journal Direct-to-
`Consumer Meetings
`1
`1
`1
`2
`2
`2
`15
`10
`6
`6
`3
`3
`5
`10
`5
`7
`10
`10
`9
`10
`11
`10
`6
`15
`11
`10
`13
`8
`7
`8
`3
`4
`7
`4
`5
`9
`14
`10
`4
`13
`10
`17
`15
`10
`19
`15
`10
`18
`15
`10
`11
`15
`8
`20
`15
`10
`20
`15
`10
`13
`15
`10
`20
`15
`10
`16
`12
`9
`20
`n/a
`n/a
`n/a
`
`Total
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`n/a
`
`Notes and sources:
`Figures are in millions of $U.S.
`Data are from Ex. 2177: AED Marketing Spend Data 2009 - 2014, at 3-6.
`
`Attachment D-1
`Page 1 of 1
`
`00011
`
`

`

`Attachment D-2
`Page 1 of 1
`
`Attachment D-2
`Chart of AED Marketing Spend by Category, 2009-2014
`
` $100
`
` $90
`
` $80
`
` $70
`
` $60
`
` $50
`
` $40
`
` $30
`
` $20
`
` $10
`
` $-
`
`Total Marketing Spend
`
`Notes and sources:
`Figures are in millions of $U.S.
`Attachment D-1.
`Lyrica is outside the chart range.
`
`AED
`
`00012
`
`