Certificates of Supplementary Protection (CSP) and Applications

The Office of Patented Medicines and Liaison (OPML) should be contacted in advance of a CSP application filing deadline in order to obtain a CSP Customer Number or to confirm an existing CSP Customer Number, if it is not known. It may take up to five business days to provide CSP Customer Number information.

Register of Certificates of Supplementary Protection and Applications

Certificates of Supplementary Protection and Applications - Human Use
Certificate of Supplementary Protection (CSP) and/or Application Number Medicinal Ingredient(s) New Drug Submission (NDS) Number Patent Number Patent Expiry Date
yyyy-mm-dd
Application Status CSP Term Begins
yyyy-mm-dd
CSP Term Ends
yyyy-mm-dd
900039 abemaciclib 215268 2747055 2029-12-15 Issued 2029-12-16 2031-12-15
900096 abrocitinib 245854 2900703 2034-02-11 Issued 2034-02-12 2036-02-11
900045 acalabrutinib 214504 2841886 2032-07-11 Issued 2032-07-12 2034-07-11
900056 alpelisib 226941 2734819 2029-09-08 Issued 2029-09-09 2031-09-08
900114 amivantamab 254440 2893505 2033-11-21 Issued 2033-11-22 2035-11-21
900089 anifrolumab 246187 2713981 2029-02-06 Withdrawn N/A N/A
900035 antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 2586379 2025-11-14 Issued 2025-11-15 2027-11-14
900027 apalutamide 211942 2875767 2033-06-04 Issued 2033-06-05 2033-07-04
900100 asciminib hydrochloride 255700 2868958 2033-05-09 Issued 2033-05-10 2035-05-09
900113 atogepant 253186 2817100 2031-11-10 Issued 2031-11-11 2033-11-10
900095 avacopan 248255 2747522 2029-12-21 Issued 2029-12-22 2031-12-21
900127 avatrombopag maleate 251688 2660283 2027-08-08 Issued 2027-08-09 2029-08-08
900088 avelumab 204052 2856895 2032-11-21 Issued 2032-11-22 2032-12-19
900026 baricitinib 193687 2718271 2029-03-10 Issued 2029-03-11 2031-03-10
900102 belumosudil mesylate 245791 2926478 2033-10-07 Issued 2033-10-08 2035-10-07
900103 belzutifan 254495 2919397 2034-09-05 Issued 2034-09-06 2036-09-05
900012 benralizumab 204008 2685222 2028-05-14 Issued 2028-05-15 2030-05-14
900093 bimekizumab 238499 2823812 2032-01-11 Issued 2032-01-12 2034-01-11
900028 bictegravir sodium / emtricitabine / tenofovir alafenamide hemifumarate 203718 2416757 2021-07-20 Refused N/A N/A
900020 brigatinib 210369 2723961 2029-05-21 Issued 2029-05-22 2031-05-21
900015 brodalumab 195317 2663537 2027-10-01 Issued 2027-10-02 2029-10-01
900060 brolucizumab 226224 2727839 2029-06-25 Issued 2029-06-26 2031-06-25
900057 cabotegravir (cabotegravir sodium) 227315 2606282 2026-04-28 Issued 2026-04-29 2028-04-28
900097 cabotegravir / rilpivirine 227315 3060290 2031-01-24 Issued 2031-01-25 2033-01-24
900126 capivasertib 274859 2701057 2028-10-09 Pending
900063 cedazuridine / decitabine 234610 2702274 2028-10-16 Issued 2028-10-17 2030-10-16
900022 cenegermin 218145 2346257 2019-10-11 Refused N/A N/A
900118 ciltacabtagene autoleucel 262122 3019453 2037-08-10 Issued 2037-08-11 2038-02-10
900011 coagulation factor IX (recombinant), pegylated 201114 2462930 2022-10-09 Refused N/A N/A
900052 coagulation factor IX (recombinant), pegylated 201114 2665480 2027-10-04 Refused N/A N/A
900115 concizumab 267120 2745317 2029-12-18 Issued 2029-12-19 2031-12-18
900084 COVID-19 vaccine (ChAdOx1-S [recombinant]) 252495 2837274 2032-05-25 Refused N/A N/A
900019 crisaborole 206906 2597982 2026-02-16 Issued 2026-02-17 2028-02-16
900041 dacomitinib 214572 2565812 2025-04-25 Issued 2025-04-26 2027-04-25
900119 daridorexant hydrochloride 255507 2873341 2033-06-03 Issued 2033-06-04 2035-06-03
900058 darolutamide 226146 2777896 2030-10-27 Issued 2030-10-28 2032-10-27
900017 darunavir ethanolate / cobicistat / emtricitabine / tenofovir alafenamide hemifumarate 199705 2678907 2028-02-22 Issued 2028-02-23 2030-02-22
900110 deucravacitinib 259397 2890981 2033-11-07 Issued 2033-11-08 2035-11-07
900106 difelikefalin (difelikefalin acetate) 254548 2667155 2027-11-12 Issued 2027-11-13 2029-11-12
900051 dolutegravir (dolutegravir sodium) / lamivudine 220275 3003988 2031-01-24 Issued 2031-01-25 2033-01-24
900021 dolutegravir (dolutegravir sodium) / rilpivirine (rilpivirine hydrochloride) 206402 2606282 2026-04-28 Refused N/A N/A
900034 doravirine 211293 2794377 2031-03-28 Issued 2031-03-29 2033-03-28
900004 dupilumab 201285 2737044 2029-10-27 Issued 2029-10-28 2031-10-27
900010 durvalumab 202953 2778714 2030-11-24 Issued 2030-11-25 2032-11-04
900128 elranatamab 273519 2925329 2036-03-30 Pending    
900024 emicizumab 212635 2817964 2031-11-17 Issued 2031-11-18 2033-08-03
900053 entrectinib 227517 2693901 2028-07-08 Issued 2028-07-09 2030-07-08
900074 eptinezumab 233288 2836649 2032-05-21 Issued 2032-05-22 2034-05-21
900070 erdafitinib 224529 2796204 2031-04-28 Issued 2031-04-29 2033-04-28
900025 erenumab 208607 2746858 2029-12-18 Issued 2029-12-19 2031-12-18
900018 ertugliflozin 204724 2733795 2029-08-17 Issued 2029-08-18 2031-08-17
900076 estetrol monohydrate / drospirenone 236197 2448278 2022-05-23 Issued 2022-05-24 2024-05-23
900099 faricimab 253904 2874554 2033-07-11 Issued 2033-07-12 2035-07-11
900129 finerenone 258231 3146285 2035-07-29 Pending    
900033 fluticasone furoate, umeclidinium (as bromide), vilanterol (as trifenatate) 204880 2781487 2030-11-29 Issued 2030-11-30 2032-11-29
900044 galcanezumab 219521 2802102 2031-06-07 Issued 2031-06-08 2033-06-07
900055 gilteritinib fumarate 227918 2760061 2030-05-06 Issued 2030-05-07 2032-05-06
900062 glasdegib 225793 2690953 2028-06-16 Issued 2028-06-17 2030-06-16
900001 glecaprevir / pibrentasvir 202233 2807847 2031-10-12 Refused N/A N/A
900014 glycopyrronium (as bromide) / formoterol fumarate dihydrate 201306 2763936 2030-05-28 Refused N/A N/A
900003 guselkumab 200590 2635692 2026-12-28 Issued 2026-12-29 2028-12-28
900085 inclisiran sodium 243470 2892160 2033-12-05 Issued 2033-12-06 2035-12-05
900090 infigratinib phosphate 246904 2781431 2030-12-06 Refused N/A N/A
900032 inotersen (inotersen sodium) 214274 2797792 2031-04-29 Issued 2031-04-30 2033-04-29
900023 insulin glargine / lixisenatide 207006 2740685 2029-10-09 Issued 2029-10-10 2031-10-09
900029 lanadelumab 213920 2786019 2031-01-06 Issued 2031-01-07 2033-01-06
900043 larotrectinib (larotrectinib sulfate) 219998 2741313 2029-10-21 Issued 2029-10-22 2031-10-21
900066 lefamulin (supplied as lefamulin acetate) 233292 2678795 2028-03-19 Issued 2028-03-20 2030-03-19
900069 lemborexant 231286 2811895 2031-09-20 Issued 2031-09-21 2033-09-20
900109 lenacapavir (lenacapavir sodium) 262999 3021227 2037-08-17 Issued 2037-08-18 2037-11-03
900007 letermovir 204165 2524069 2024-04-17 Issued 2024-04-18 2026-04-17
900009 lifitegrast 199810 2609053 2026-05-17 Issued 2026-05-18 2028-05-17
900040 lorlatinib 215733 2863892 2033-02-20 Issued 2033-02-21 2034-02-23
900087 lurbinectedin 247485 2455768 2022-08-06 Issued 2022-08-07 2024-08-06
900071 luspatercept 236441 2733911 2029-08-13 Issued 2029-08-14 2031-08-13
900104 lutetium (177lu) vipivotide tetraxetan 260951 2924360 2034-10-17 Issued 2034-10-18 2036-10-17
900086 macitentan / tadalafil 245848 2659770 2027-08-28 Issued 2027-08-29 2029-08-28
900111 mavacamten 258772 2915967 2034-06-19 Issued 2034-06-20 2036-06-19
900120 mirikizumab 266471 2901462 2034-03-04 Issued 2034-03-05 2036-03-04
900002 neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily A / neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily B 195550 2463476 2022-10-11 Issued 2022-10-12 2024-10-11
900122 nivolumab / relatlimab 256629 2877746 2033-07-02 Issued 2033-07-03 2035-07-02
900008 olaratumab 203478 2680945 2026-06-19 Issued 2026-06-20 2028-06-19
900072 ozanimod (ozanimod hydrochloride) 232761 2723904 2029-05-14 Issued 2029-05-15 2031-05-14
900073 ozanimod (ozanimod hydrochloride) 232761 2780772 2030-11-15 Withdrawn N/A N/A
900091 palovarotene 252065 2809374 2031-08-31 Issued 2031-09-01 2033-08-31
900094 pemigatinib 242569 2876689 2033-06-12 Issued 2033-06-13 2035-06-12
900080 pertuzumab, trastuzumab 237402 2788253 2032-08-29 Refused N/A N/A
900098 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F)* *conjugated to diphtheria CRM197 protein 253111 2881420 2033-08-12 Withdrawn N/A N/A
900092 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F)* *conjugated to CRM197 protein 247042 2788680 2031-02-03 Issued 2031-02-04 2033-02-03
900121 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F)* *conjugated to diphtheria CRM197 protein 253111 3170344 2035-01-15 Issued 2035-01-16 2037-01-15
900067 polatuzumab vedotin 232303 2693255 2028-07-15 Issued 2028-07-16 2030-07-15
900079 ponesimod 239537 2968180 2035-12-10 Issued 2035-12-11 2036-04-29
900050 prasterone 198822 2696127 2028-08-08 Withdrawn N/A N/A
900068 remdesivir 240551 2804840 2031-07-22 Issued 2031-07-23 2033-07-22
900016 ribociclib (ribociclib succinate) 203884 2734802 2029-08-20 Issued 2029-08-21 2031-08-20
900065 ripretinib 234688 2875970 2032-06-07 Issued 2032-06-08 2034-06-07
900042 risankizumab 215753 2816950 2031-11-02 Issued 2031-11-03 2033-11-02
900078 risdiplam 242373 2948561 2035-05-11 Issued 2035-05-12 2036-04-15
900124 ritlecitinib (ritlecitinib tosylate) 268723 2932425 2034-11-20 Pending no data no data
900031 rivaroxaban 211611 2451258 2022-06-07 Refused N/A N/A
900046 romosozumab 197713 2607197 2026-04-28 Issued 2026-04-29 2028-04-28
900125 RSV subgroup A stabilized prefusion F protein / RSV subgroup B stabilized prefusion F protein 272785 2952131 2036-12-19 Pending N/A N/A
900061 satralizumab 233642 2699834 2029-09-25 Issued 2029-09-26 2031-09-25
900005 semaglutide 202059 2601784 2026-03-20 Issued 2026-03-21 2028-03-20
900054 siponimod 223225 2747437 2029-12-16 Withdrawn N/A N/A
900059 siponimod 223225 2747992 2029-12-21 Issued 2029-12-22 2031-12-21
900117 somatrogon 246729 2928269 2034-10-21 Issued 2034-10-22 2036-10-21
900112 spesolimab 267362 2852994 2032-11-14 Issued 2032-11-15 2034-11-14
900038 suvorexant 160233 2670892 2027-11-30 Refused N/A N/A
900107 tafasitamab 247025 2841738 2032-08-14 Issued 2032-08-15 2034-08-14
900048 talazoparib (talazoparib tosylate) 220584 2732797 2029-07-27 Issued 2029-07-28 2031-07-27
900101 tebentafusp 258717 2766505 2030-07-01 Issued 2030-07-02 2032-07-01
900082 tepotinib hydrochloride 242300 2693600 2028-04-29 Issued 2028-04-30 2030-04-29
900036 tezacaftor / Ivacaftor 211292 2742821 2028-11-12 Issued 2028-11-13 2030-11-12
900105 tezepelumab 256188 2698382 2028-09-09 Issued 2028-09-10 2030-09-09
900108 tirzepatide 259103 2973352 2036-01-05 Issued 2036-01-06 2037-11-25
900030 tisagenlecleucel 213547 2820681 2031-12-09 Issued 2031-12-10 2033-12-09
900081 trastuzumab deruxtecan 242104 2928794 2035-01-28 Issued 2035-01-29 2036-04-16
900064 tucatinib 235295 2632194 2026-11-15 Issued 2026-11-16 2028-11-15
900049 upadacitinib 223734 2781891 2030-12-01 Issued 2030-12-02 2032-12-01
900006 varicella-zoster virus glycoprotein E (gE) 200244 2600905 2026-03-01 Refused N/A N/A
900116 vericiguat 240862 2800697 2031-05-24 Issued 2031-05-25 2033-05-24
900075 zanubrutinib 242748 2902686 2034-04-22 Issued 2034-04-23 2036-03-02
Certificates of Supplementary Protection and Applications - Veterinary Use
Certificate of Supplementary Protection (CSP) and/or
Application Number
Medicinal Ingredient(s) New Drug Submission (NDS) Number Patent Number Patent Expiry Date
yyyy-mm-dd
Application Status CSP Term Begins
yyyy-mm-dd
CSP Term Ends
yyyy-mm-dd
900083 ciclesonide 200882 2888428 2033-12-18 Issued 2033-12-19 2035-05-01
900077 esafoxolaner / eprinomectin / praziquantel 234676 2848317 2032-09-12 Refused N/A N/A
900013 lotilaner 193712 2747354 2029-12-17 Issued 2029-12-18 2031-12-17
900047 sarolaner / moxidectin / pyrantel (as pyrantel pamoate) 210868 2882200 2033-09-04 Issued 2033-09-05 2034-09-27
900037 sarolaner / selamectin 190913 2828397 2032-02-23 Issued 2032-02-24 2033-11-07
900123 velagliflozin L-proline monohydrate 265785 2930034 2034-12-15 Pending    

Background

The Register of Certificates of Supplementary Protection (CSP) and Applications is maintained pursuant to the Certificate of Supplementary Protection Regulations and the Patent Act. The register includes information from CSPs and CSP applications. Under the subsection 115(1) of the Patent Act, the issuance of a CSP grants the certificate's holder and their legal representatives the same legal rights, privileges and liberties that are granted by the patent set out in the certificate, but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients.

The format of the register is an electronic table. The register lists, in alphabetical order, the medicinal ingredient(s) in the CSPs and CSP applications.

Information regarding the patent set out in the CSP or CSP application is available at the Canadian Intellectual Property Office.

For comments or questions, or to obtain a copy of a CSP or CSP application details, please contact the Office of Patented Medicines and Liaison by email at opml-bmbl@hc-sc.gc.ca or by telephone at 613-941-7281.

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