PDF Register Of Innovative Drugs Products for Human Use - Active ...

Register Of Innovative Drugs

Products for Human Use - Active Data Protection Period

Medicinal Ingredient(s)* abemaciclib

Submission Number

Innovative Drug

215268

Verzenio

Manufacturer Eli Lilly Canada Inc.

Drug(s) Containing the Medicinal Ingredient / Variations N/A

Notice of Compliance

Date yyyy-mm-dd 2019-04-08

6 Year "No File" Date

2025-04-08

Pediatric Extension

Data Protection

Yes / No

Ends

N/A

2027-04-08

abiraterone acetate

138343

Zytiga

Janssen Inc.

N/A

2011-07-27 2017-07-27

N/A

2019-07-27

aclidinium bromide

157598

Tudorza Genuair

AstraZeneca Canada Inc.

Duaklir Genuair

2013-07-29 2019-07-29

N/A

2021-07-29

afatinib dimaleate aflibercept albiglutide alectinib hydrochloride alirocumab alogliptin benzoate

anthrax antigen filtrate

anthrax immune globulin (human)

158730 149321 165145 189442 183116 158335

Giotrif Eylea Eperzan Alecensaro Praluent Nesina

212387

Biothrax

200446

Anthrasil

Boehringer Ingelheim (Canada) Ltd.

N/A

Bayer Inc.

N/A

GlaxoSmithKline Inc.

N/A

Hoffmann-La Roche Limited

N/A

Sanofi-aventis Canada Inc.

N/A

Takeda Canada Inc.

Kazano Oseni

Emergent Biodefense Operations

N/A

Lansing LLC

Emergent BioSolutions Canada Inc.

N/A

2013-11-01 2019-11-01

N/A

2013-11-08 2019-11-08

N/A

2015-07-15 2021-07-15

N/A

2016-09-29 2022-09-29

N/A

2016-04-11 2022-04-11

N/A

2013-11-27 2019-11-27

N/A

2018-12-13 2024-12-13

N/A

2017-11-06 2023-11-06

Yes

2021-11-01 2021-11-08 2023-07-15 2024-09-29 2024-04-11 2021-11-27

2026-12-13

2026-05-06

antihemophilic factor (recombinant BDD), Fc fusion protein

antihemophilic factor (recombinant), pegylated

antihemophilic factor (recombinant, Bdomain deleted) (also known as simoctocog alfa)

antihemophilic factor (recombinant, Bdomain deleted, pegylated) (also known as damoctocog alfa pegol)

163447 189709 169551 210935

Eloctate Adynovate Nuwiq Jivi

Bioverativ Canada Inc.

Baxalta Canada Corporation

Octapharma Pharmazeutika Produktionsges.m.b.H Bayer Inc.

N/A

2014-08-22 2020-08-22

Yes

2023-02-22

N/A

2016-11-17 2022-11-17

Yes

2025-05-17

N/A

2014-10-23 2020-10-23

Yes

2023-04-23

N/A

2018-10-18 2024-10-18

Yes

2027-04-18

Page 1 of 30

2019-05-02

Register Of Innovative Drugs

Products for Human Use - Active Data Protection Period

Medicinal Ingredient(s)*

antihemophilic factor VIII (recombinant), singlechain (also known as lonoctocog alfa) apalutamide

Submission Number

Innovative Drug

190891

Afstyla

Manufacturer CSL Behring Canada Inc.

211942

Erleada

Janssen Inc.

Drug(s) Containing the Medicinal Ingredient / Variations N/A

Notice of Compliance

Date yyyy-mm-dd 2016-12-12

6 Year "No File" Date

2022-12-12

Pediatric Extension

Data Protection

Yes / No

Ends

Yes

2025-06-12

N/A

2018-07-03 2024-07-03

N/A

2026-07-03

apixaban apremilast asenapine maleate asfotase alfa asunaprevir atezolizumab avelumab axicabtagene ciloleucel

141873 169862 127427 179340 172617 196843 204052 218389

Eliquis Otezla Saphris Strensiq Sunvepra Tecentriq Bavencio Yescarta

Bristol-Myers Squibb Canada

N/A

Celgene Inc.

N/A

Merck Canada Inc.

N/A

Alexion Pharma International S?rl

N/A

Bristol-Myers Squibb Canada

N/A

Hoffmann-La Roche Limited

N/A

EMD Serono, a Division of EMD Inc.,

N/A

Canada

Gilead Sciences Canada Inc

N/A

2011-12-16 2017-12-16

Yes

2014-11-12 2020-11-12

N/A

2011-10-07 2017-10-07

Yes

2015-08-14 2021-08-14

Yes

2016-03-09 2022-03-09

N/A

2017-04-12 2023-04-12

N/A

2017-12-18 2023-12-18

N/A

2019-02-13 2025-02-13

N/A

2020-06-16 2022-11-12 2020-04-07 2024-02-14 2024-03-09 2025-04-12 2025-12-18 2027-02-13

axitinib azelastine hydrochloride azilsartan medoxomil potassium

144404 169604 145305

Inlyta Dymista Edarbi

Pfizer Canada Inc. Meda Pharmaceuticals Ltd. Valeant Canada LP

N/A N/A Edarbyclor

2012-07-12 2018-07-12

Yes

2014-10-23 2020-10-23

Yes

2012-03-08 2018-03-08

N/A

2021-01-12 2023-04-23 2020-03-08

baricitinib

193687

Olumiant

Eli Lilly Canada Inc.

N/A

2018-08-17 2024-08-17

N/A

2026-08-17

bazedoxifene acetate belimumab bendamustine hydrochloride

160681 137699 149814

Duavive Benlysta Treanda

Pfizer Canada Inc. GlaxoSmithKline Inc. Teva Canada Limited

N/A

2014-10-23 2020-10-23

N/A

2022-10-23

N/A

2011-07-06 2017-07-06

N/A

2019-07-06

N/A

2012-08-24 2018-08-24

Yes

2021-02-24

Page 2 of 30

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Register Of Innovative Drugs

Products for Human Use - Active Data Protection Period

Medicinal Ingredient(s)* benralizumab

Submission Number

Innovative Drug

204008

Fasenra

Manufacturer AstraZeneca Canada Inc.

Drug(s) Containing the Medicinal Ingredient / Variations N/A

Notice of Compliance

Date yyyy-mm-dd 2018-02-22

6 Year "No File" Date

2024-02-22

Pediatric Extension

Data Protection

Yes / No

Ends

Yes

2026-08-22

bepotastine besilate

179294

Bepreve

Bausch and Lomb Incorporated

N/A

2016-07-27 2022-07-27

Yes

2025-01-27

bictegravir

203718

Biktarvy

Gilead Sciences Canada, Inc.

N/A

2018-07-10 2024-07-10

N/A

2026-07-10

bilastine

blinatumomab boceprevir bosutinib botulism antitoxin heptavalent C/ D/F/ G ? (equine) brentuximab vedotin brexpiprazole brigatinib brivaracetam brodalumab bromfenac sodium sesquihydrate

burosumab

cabazitaxel

184231 181723 141556 152211 190645

Blexten Blincyto Victrelis Bosulif Bat

154851 192684 210369 183355 195317 171657 216239 137421

Adcetris Rexulti Alunbrig Brivlera Siliq Prolensa Crysvita Jevtana

Aralez Pharmaceutials Canada Inc.

N/A

Amgen Canada Incorporated Merck Canada Inc. Pfizer Canada Inc. Emergent BioSolutions Inc.

N/A Victrelis Triple

N/A N/A

Seattle Genetics Inc.

N/A

Otsuka Pharmaceutical Co. Ltd.

N/A

Takeda Canada Incorporated

N/A

UCB Canada Incorporated

N/A

Valeant Canada LP/Valeant Canada

N/A

S.E.C.

Bausch & Lomb Incorporated

N/A

Kyowa Kirin Limited

N/A

Sanofi-aventis Canada Inc.

N/A

2016-04-21 2022-04-21

Yes

2015-12-22 2021-12-22

Yes

2011-07-29 2017-07-29

N/A

2014-03-07 2020-03-07

N/A

2016-12-08 2022-12-08

Yes

2013-02-01 2019-02-01

N/A

2017-02-16 2023-02-16

N/A

2018-07-26 2024-07-26

N/A

2016-03-09 2022-03-09

Yes

2018-03-06 2024-03-06

N/A

2015-03-26 2021-03-26

N/A

2018-12-05 2024-12-05

Yes

2011-06-16 2017-06-16

Yes

2024-10-21 2024-06-22 2019-07-29 2022-03-07 2025-06-08

2021-02-01 2025-02-16 2026-07-26 2024-09-09 2026-03-06 2023-03-26 2027-06-05 2019-12-16

Page 3 of 30

2019-05-02

Register Of Innovative Drugs

Products for Human Use - Active Data Protection Period

Medicinal Ingredient(s)*

cabozantinib (supplied as cabozantinib (S)-malate)

Submission Number

Innovative Drug

206230

Cabometyx

Manufacturer Ipsen Biopharmaceuticals Canada Inc.

Drug(s) Containing the Medicinal Ingredient / Variations N/A

calcifediol

205392

Rayaldee

Vifor Fresenius Medical Care Renal

N/A

Pharma Ltd

canagliflozin

157505

Invokana

Janssen Inc.

Invokamet Invokamet XR

Notice of Compliance

Date yyyy-mm-dd 2018-09-14

2018-07-10

2014-05-23

6 Year "No File" Date 2024-09-14

2024-07-10

2020-05-23

Pediatric Extension

Data Protection

Yes / No

Ends

N/A

2026-09-14

N/A

2026-07-10

N/A

2022-05-23

carfilzomib

184479

Kyprolis

Amgen Canada Inc.

N/A

2016-01-15 2022-01-15

N/A

2024-01-15

carglumic acid

171358

Carbaglu

Orphan Europe Sarl

N/A

2015-04-10 2021-04-10

Yes

2023-10-10

catridecacog catumaxomab ceftolozane

152228 142629 178006

Tretten Removab Zerbaxa

Novo Nordisk Canada Inc. Fresenius Biotech GmbH Merck Canada Inc.

N/A

2012-07-19 2018-07-19

Yes

2021-01-19

N/A

2012-05-11 2018-05-11

N/A

2020-05-11

N/A

2015-09-30 2021-09-30

N/A

2023-09-30

cemiplimab

218718

Libtayo

Sanofi-Aventis Canada Inc.

N/A

2019-04-10 2025-04-10

N/A

2027-04-10

cenegermin

218145

Oxervate

Domp? farmaceutici S.p.A.

N/A

2019-02-08 2025-02-08

N/A

2027-02-08

ceritinib

cerliponase alfa

coagulation factor IX (recombinant), albumin fusion protein

coagulation factor IX (recombinant), pegylated (nonacog beta pegol)

coagulation factor IX, Fc fusion protein cobimetinib

175702 216539 180793

Zykadia Brineura Idelvion

201114

Rebinyn

163614 182788

Alprolix Cotellic

Novartis Pharmaceuticals Canada Inc.

N/A

Biomarin International Limited

N/A

CSL Behring Canada Inc.

N/A

Novo Nordisk Canada Inc.

N/A

Bioverativ Canada Inc.

N/A

Hoffmann-La Roche Limited

N/A

2015-03-27 2021-03-27

N/A

2018-12-19 2024-12-19

Yes

2016-01-26 2022-01-26

Yes

2017-11-29 2023-11-29

Yes

2014-03-20 2020-03-20

Yes

2016-02-22 2022-02-22

N/A

2023-03-27 2027-06-19 2024-07-26 2026-05-29 2022-09-20 2024-02-22

Page 4 of 30

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Register Of Innovative Drugs

Products for Human Use - Active Data Protection Period

Medicinal Ingredient(s)* colesevelam hydrochloride

Submission Number

Innovative Drug

133463

Lodalis

Manufacturer

Valeant Canada LP / Valeant Canada S.E.C.

Drug(s) Containing the Medicinal Ingredient / Variations N/A

collagenase clostridium histolyticum

147788

Xiaflex

Endo Ventures Ltd.

N/A

Notice of Compliance

Date yyyy-mm-dd 2011-09-22

2012-07-05

6 Year "No File" Date 2017-09-22

2018-07-05

Pediatric Extension

Data Protection

Yes / No

Ends

N/A

2019-09-22

N/A

2020-07-05

crisaborole crizotinib cysteamine bitartrate dabrafenib mesylate daclatasvir daclizumab beta dacomitinib dalbavancin (supplied as dalbavancin hydrochloride) dapagliflozin propanediol

daratumumab deferiprone defibrotide sodium dienogest difluprednate dimethyl fumarate

206906 145155 191347 157590 172616 190458 214572 212390

160877

187648 162924 200808 132174 154517 154776

Eucrisa Xalkori Procysbi Tafinlar Daklinza Zinbryta Vizimpro Xydalba

Forxiga

Darzalex Ferriprox Defitelio Visanne Durezol Tecfidera

Pfizer Canada Inc.

N/A

Pfizer Canada Inc.

N/A

Horizon Pharma Ireland Ltd.

N/A

Novartis Pharmaceuticals Canada Inc.

N/A

Bristol-Myers Squibb Canada

N/A

Biogen Canada Inc.

N/A

Pfizer Canada Inc.

N/A

Cipher Pharmaceuticals Inc.

N/A

AstraZeneca Canada Inc. Janssen Inc. ApoPharma Inc.

Xigduo Qtern

N/A

N/A

Jazz Pharmaceuticals Ireland Limited

N/A

Bayer Inc.

Natazia

Novartis Pharmaceuticals Canada Inc.

N/A

Biogen Idec Canada Inc.

N/A

2018-06-07 2024-06-07

Yes

2012-04-25 2018-04-25

Yes

2017-06-13 2023-06-13

Yes

2013-07-16 2019-07-16

N/A

2015-08-13 2021-08-13

N/A

2016-12-08 2022-12-08

N/A

2019-02-26 2025-02-26

N/A

2018-09-04 2024-09-04

N/A

2014-12-12 2020-12-12

N/A

2016-06-29 2022-06-29

N/A

2015-02-13 2021-02-13

Yes

2017-07-10 2023-07-10

Yes

2011-10-12 2017-10-12

Yes

2013-11-04 2019-11-04

Yes

2013-04-03 2019-04-03

Yes

2026-12-07 2020-10-25 2025-12-13 2021-07-16 2023-08-13 2024-12-08 2027-02-26 2026-09-04

2022-12-12

2024-06-29 2023-08-13 2026-01-10 2020-04-12 2022-05-04 2021-10-03

Page 5 of 30

2019-05-02

Register Of Innovative Drugs

Products for Human Use - Active Data Protection Period

Medicinal Ingredient(s)* dinutuximab dolutegravir sodium

Submission Number

Innovative Drug

212066

Unituxin

161084

Tivicay

Manufacturer United Therapeutics Corporation ViiV Healthcare ULC

doravirine

211293

Pifeltro

Merck Canada Inc.

Drug(s) Containing the Medicinal Ingredient / Variations N/A

Notice of Compliance

Date yyyy-mm-dd 2018-11-28

6 Year "No File" Date

2024-11-28

Pediatric Extension

Data Protection

Yes / No

Ends

Yes

2027-05-28

Triumeq Juluca

2013-10-31 2019-10-31

Yes

2022-05-01

Delstrigo

2018-10-12 2024-10-12

N/A

2026-10-12

dulaglutide dupilumab durvalumab edaravone edoxaban efinaconazole elagolix eliglustat tartrate elosulfase alfa elotuzumab eltrombopag olamine eluxadoline

168671 201285 202953 214391 187363 159416 209513 183050 170340 188144 123984 190162

Trulicity Dupixent Imfinzi Radicava Lixiana Jublia Orilissa Cerdelga Vimizim Empliciti Revolade Viberzi

Eli Lilly Canada Inc.

N/A

Sanofi-Aventis Canada Inc.

N/A

AstraZeneca Canada Inc.

N/A

Mitsubishi Tanabe Pharma

N/A

Corporation

Servier Canada Inc.

N/A

Valeant Canada LP / Valeant Canada

N/A

S.E.C.

AbbVie Corporation

N/A

Genzyme Canada, A division of Sanofi-

N/A

aventis Canada Inc.

Biomarin International Limited

N/A

Bristol-Myers Squibb Canada

N/A

Novartis Pharmaceuticals Canada Inc.

N/A

Allergan Pharma Co.

N/A

2015-11-10 2021-11-10

N/A

2017-11-30 2023-11-30

N/A

2017-11-03 2023-11-03

N/A

2018-10-03 2024-10-03

N/A

2016-11-04 2022-11-04

N/A

2013-10-02 2019-10-02

N/A

2018-10-05 2024-10-05

N/A

2017-04-21 2023-04-21

N/A

2014-07-02 2020-07-02

Yes

2016-06-21 2022-06-21

N/A

2011-01-12 2017-01-12

Yes

2017-01-26 2023-01-26

N/A

2023-11-10 2025-11-30 2025-11-03 2026-10-03 2024-11-04 2021-10-02 2026-10-05 2025-04-21 2023-01-02 2024-06-21 2019-07-12 2025-01-26

Page 6 of 30

2019-05-02

Register Of Innovative Drugs

Products for Human Use - Active Data Protection Period

Medicinal Ingredient(s)* elvitegravir, cobicistat

Submission Number

Innovative Drug

152198

Stribild

Manufacturer Gilead Sciences Canada Inc.

emicizumab

212635

Hemlibra

Hoffmann-La Roche Limited

Drug(s) Containing the Medicinal Ingredient / Variations

Tybost Vitekta Prezcobix Evotaz Genvoya Symtuza

N/A

Notice of Compliance

Date yyyy-mm-dd 2012-11-26

2018-08-02

6 Year "No File" Date 2018-11-26

2024-08-02

Pediatric Extension

Data Protection

Yes / No

Ends

N/A

2020-11-26

Yes

2027-02-02

empagliflozin

162552

Jardiance

Boehringer Ingelheim (Canada) Ltd. Synjardy Glyxambi

2015-07-23 2021-07-23

N/A

2023-07-23

enasidenib mesylate

217033

Idhifa

Celgene Inc.

N/A

2019-02-06 2025-02-06

N/A

2027-02-06

enzalutamide erenumab eribulin mesylate ertugliflozin

eslicarbazepine acetate evolocumab ezogabine fampridine ferumoxytol

159678 208607 141946 204724

Xtandi Aimovig Halaven Steglatro

165665 178234 134659 132859 133250

Aptiom Repatha Potiga Fampyra Feraheme

Astellas Pharma Canada Inc.

N/A

Novartis Pharmaceuticals Canada Inc.

N/A

Eisai Limited

N/A

Merck Canada Inc.

Steglujan Segluromet

Sunovion Pharmaceuticals Canada

N/A

Inc.

Amgen Canada Inc.

N/A

GlaxoSmithKline Inc.

N/A

Biogen Idec Canada Inc.

N/A

AMAG Pharmaceuticals Inc.

N/A

2013-05-29 2019-05-29

N/A

2018-08-01 2024-08-01

N/A

2011-12-14 2017-12-14

N/A

2018-05-09 2024-05-09

N/A

2014-07-08 2020-07-08

Yes

2015-09-10 2021-09-10

Yes

2012-10-18 2018-10-18

N/A

2012-02-10 2018-02-10

N/A

2011-12-08 2017-12-08

N/A

2021-05-29 2026-08-01 2019-12-14 2026-05-09

2023-01-08 2024-03-10 2020-10-18 2020-02-10 2019-12-08

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2019-05-02

Register Of Innovative Drugs

Products for Human Use - Active Data Protection Period

Medicinal Ingredient(s)* fesoterodine fumarate

Submission Number

Innovative Drug

142326

Toviaz

Manufacturer Pfizer Canada Inc.

Drug(s) Containing the Medicinal Ingredient / Variations N/A

Notice of Compliance

Date yyyy-mm-dd 2012-02-09

6 Year "No File" Date

2018-02-09

Pediatric Extension

Data Protection

Yes / No

Ends

Yes

2020-08-09

fidaxomicin

151086

Dificid

Merck Canada Inc.

N/A

2012-06-07 2018-06-07

N/A

2020-06-07

finafloxacin

172450

Xtoro

MerLion Pharmaceuticals GmbH

N/A

2016-03-11 2022-03-11

Yes

2024-09-11

flibanserin

189352

Addyi

Sprout Pharmaceuticals Inc.

N/A

2018-02-27 2024-02-27

N/A

2026-02-27

florbetaben (18F) follitropin delta

193105

Neuraceq

188743

Rekovelle

Isologic Innovative Radiopharmaceuticals Ltd.

Ferring Inc.

N/A

2017-02-22 2023-02-22

N/A

2025-02-22

N/A

2018-03-22 2024-03-22

N/A

2026-03-22

gadoterate meglumine galsulfase glecaprevir, pibrentasvir glycerol phenylbutyrate grazoprevir, elbasvir guanfacine hydrochloride guselkumab haemagglutinin strain A (H5N1)

hemin

ibrutinib

186333 159020 202233 174219 185866 150741 200590 115398

212276

174029

Dotarem Naglazyme Maviret Ravicti Zepatier Intuniv XR Tremfya Arepanrix H5N1

Panhematin

Imbruvica

Guerbet

N/A

BioMarin Pharmaceutical Inc.

N/A

AbbVie Corporation

N/A

Horizon Pharma Ireland Ltd.

N/A

Merck Canada Inc.

N/A

Shire Pharma Canada ULC.

N/A

Janssen Inc.

N/A

ID Biomedical Corporation of Quebec

N/A

Recordati Rare Diseases Canada Inc.

N/A

Janssen Inc.

N/A

2016-11-26 2022-11-26

Yes

2013-09-16 2019-09-16

Yes

2017-08-16 2023-08-16

N/A

2016-03-18 2022-03-18

Yes

2016-01-19 2022-01-19

N/A

2013-07-05 2019-07-05

Yes

2017-11-10 2023-11-10

N/A

2013-02-13 2019-02-13

Yes

2018-07-13 2024-07-13

N/A

2014-11-17 2020-11-17

N/A

2025-05-26 2022-03-16 2025-08-16 2024-09-18 2024-01-19 2022-01-05 2025-11-10 2021-08-13

2026-07-13

2022-11-17

Page 8 of 30

2019-05-02

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