Apotex Drug Patent Portfolio
Apotex owns 10 orange book drugs protected by 55 US patents with Evdi having the least patent protection, holding only 1 patent. And Paxil with maximum patent protection, holding 18 patents. Given below is the list of Apotex's drug patents along with their expiration dates.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US12303506 | Trabectedin Composition | 18 Feb, 2043 | Active |
| US10537520 | Stable liquid formulations of melphalan | 29 Jun, 2036 | Active |
| US8952065 | Acetylcysteine composition and uses thereof | 10 Feb, 2035 | Active |
| US8722738 | Acetycysteine compositions and methods of use thereof | 06 Apr, 2032 | Active |
| US11806400 | Injectable ibuprofen formulation | 16 Mar, 2032 | Active |
| US9072661 | Injectable ibuprofen formulation | 16 Mar, 2032 | Active |
| US9072710 | Injectable ibuprofen formulation | 16 Mar, 2032 | Active |
| US9327028 | Acetylcysteine compositions and methods of use thereof | 21 Jul, 2031 | Active |
| US9012508 | Administration of intravenous ibuprofen | 14 Sep, 2030 | Active |
| US8735452 | Treating patients with intravenous ibuprofen | 30 Sep, 2029 | Active |
| US8871810 | Treating critically ill patients with intravenous ibuprofen | 30 Sep, 2029 | Active |
| US9114068 | Treating patients with intravenous ibuprofen | 30 Sep, 2029 | Active |
| US9138404 | Treating critically ill patients with intravenous ibuprofen | 30 Sep, 2029 | Active |
| US9295639 | Treating critically ill patients with intravenous ibuprofen | 30 Sep, 2029 | Active |
| US9649284 | Treating critically ill patients with intravenous ibuprofen | 30 Sep, 2029 | Active |
| US7531623 | Hydrochloride salts of a glycopeptide phosphonate derivative | 01 Jan, 2027 | Active |
| US8148356 | Acetylcysteine composition and uses therefor | 21 May, 2026 | Expired |
| US8399445 | Acetylcysteine composition and uses thereof | 24 Aug, 2025 | Expired |
| US8653061 | Acetylcysteine composition and uses thereof | 24 Aug, 2025 | Expired |
| US7608282 | Transdermal granisetron | 22 Jan, 2025 | Expired |
| US6635618 | Glycopeptide phosphonate derivatives | 11 Sep, 2023 | Expired |
| US6858584 | Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin | 24 Aug, 2022 | Expired |
| US6727286 | Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid | 27 Nov, 2021 | Expired |
| US6872701 | Glycopeptide phosphonate derivatives | 05 Jun, 2021 | Expired |
| US7008923 | Glycopeptide phosphonate derivatives | 06 May, 2021 | Expired |
| US7208471 | Glycopeptide phosphonate derivatives | 01 May, 2021 | Expired |
| US7351691 | Glycopeptide phosphonate derivatives | 01 May, 2021 | Expired |
| US7544364 | Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin | 01 May, 2021 | Expired |
| US7700550 | Glycopeptide phosphonate derivatives | 01 May, 2021 | Expired |
| US8101575 | Glycopeptide phosphonate derivatives | 01 May, 2021 | Expired |
| US8158580 | Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin | 01 May, 2021 | Expired |
| US5723606 | Condensed benzazepine derivative and pharmaceutical composition thereof | 15 Dec, 2019 | Expired |
| US6063927 | Paroxetine derivatives | 23 Oct, 2019 | Expired |
| US6063927 | Paroxetine derivatives | 23 Apr, 2019 | Expired |
| US6172233 | Process for making paroxetine | 15 Jul, 2018 | Expired |
| US6172233 | Process for making paroxetine | 15 Jan, 2018 | Expired |
| US6121291 | Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder | 17 Sep, 2017 | Expired |
| US6121291 | Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder | 17 Mar, 2017 | Expired |
| US6548084 | Controlled release compositions | 19 Jan, 2017 | Expired |
| US7229640 | Paroxetine controlled release compositions | 19 Jan, 2017 | Expired |
| US6548084 | Controlled release compositions | 19 Jul, 2016 | Expired |
| US7229640 | Paroxetine controlled release compositions | 19 Jul, 2016 | Expired |
| US5811436 | Oral liquid compositions containing paroxetine resinate | 22 Mar, 2016 | Expired |
| US5872132 | Form of paroxetine hydrochloride anhydrate | 19 Nov, 2015 | Expired |
| US5900423 | Form of paroxetine hydrochloride anhydrate | 19 Nov, 2015 | Expired |
| US6080759 | Paroxetine hydrochloride form A | 19 Nov, 2015 | Expired |
| US6133289 | Paroxetine hydrochloride form A or C | 19 Nov, 2015 | Expired |
| US5811436 | Oral liquid compositions containing paroxetine resinate | 22 Sep, 2015 | Expired |
| US6113944 | Paroxetine tablets and process to prepare them | 14 Jun, 2015 | Expired |
| US5872132 | Form of paroxetine hydrochloride anhydrate | 19 May, 2015 | Expired |
| US5900423 | Form of paroxetine hydrochloride anhydrate | 19 May, 2015 | Expired |
| US6080759 | Paroxetine hydrochloride form A | 19 May, 2015 | Expired |
| US6133289 | Paroxetine hydrochloride form A or C | 19 May, 2015 | Expired |
| US6113944 | Paroxetine tablets and process to prepare them | 14 Dec, 2014 | Expired |
| US5422123 | Tablets with controlled-rate release of active substances | 06 Dec, 2012 | Expired |
Latest Legal Activities on Apotex's Drug Patents
Given below is the list of recent legal activities going on the following drug patents of Apotex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Nov, 2025 | US8735452 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Oct, 2025 | US8722738 |
| Maintenance Fee Reminder Mailed | 06 Oct, 2025 | US8653061 (Litigated) |
| Expire Patent | 21 Apr, 2025 | US8399445 (Litigated) |
| Maintenance Fee Reminder Mailed | 04 Nov, 2024 | US8399445 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Oct, 2024 | US9649284 |
|
Expire Patent
Critical
| 20 May, 2024 | US8158580 |
|
Expire Patent
Critical
| 26 Feb, 2024 | US8101575 |
|
Maintenance Fee Reminder Mailed
Critical
| 04 Dec, 2023 | US8158580 |
|
Email Notification
Critical
| 07 Nov, 2023 | US11806400 |
| Mail Patent eGrant Notification | 07 Nov, 2023 | US11806400 |
|
Recordation of Patent Grant Mailed
Critical
| 07 Nov, 2023 | US11806400 |
| Patent eGrant Notification | 07 Nov, 2023 | US11806400 |
| Recordation of Patent eGrant | 07 Nov, 2023 | US11806400 |
|
Patent Issue Date Used in PTA Calculation
Critical
| 07 Nov, 2023 | US11806400 |
Apotex's Drug Patent Litigations
Apotex's drugs have been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 25, 2004, against patent number US6063927. The petitioner , challenged the validity of this patent, with FRANCISCUS BERNARDUS GEMM BENNEKER et al as the respondent. Click below to track the latest information on how companies are challenging Apotex's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9295639 | December, 2012 |
Decision
(17 Sep, 2015)
| Leo PAVLIV et al | |
| US6063927 | May, 2004 |
Motion Decision
(25 May, 2004)
| FRANCISCUS BERNARDUS GEMM BENNEKER et al | |
Apotex Drug Patents' Oppositions Filed in EPO
Apotex drug patents have faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 30, 2008, by Boeters & Lieck. This opposition was filed on patent number EP04708393A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP04708393A | Apr, 2008 | Harrison Goddard Foote | Opposition rejected |
| EP04708393A | Apr, 2008 | BOETERS & LIECK | Opposition rejected |
Apotex's Family Patents
Recent FDA approvals and tentative approvals for Apotex
This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.
Innovator drugs
Includes innovator drug submissions that appear in FDA approval and tentative approval disclosures.
| Drug Name | Submission class (FDA) | Submission Category | Submission Date |
|---|---|---|---|
| Ruxolitinib |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | Type 2 - New Active Ingredient | 29 Jul, 2026 |
Generic drugs
Includes generic drug submissions with tentative FDA approvals, not yet marketable due to patent or exclusivity restrictions.
| Drug Name | Submission class (FDA) | Submission Category | Submission Date |
|---|---|---|---|
| Ruxolitinib |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 09 Jun, 2026 |
| Tofacitinib Citrate |
ORIG-2
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 03 Jun, 2026 |
| Semaglutide |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 07 Apr, 2026 |
Apotex Drug List
Given below is the complete list of Apotex's drugs and the patents protecting them.
1. Acetadote
Acetadote is protected by 6 patents, out of which 3 have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US8952065 | Acetylcysteine composition and uses thereof |
10 Feb, 2035
(8 years from now)
| Active |
| US8722738 | Acetycysteine compositions and methods of use thereof |
06 Apr, 2032
(5 years from now)
| Active |
| US9327028 | Acetylcysteine compositions and methods of use thereof |
21 Jul, 2031
(4 years from now)
| Active |
| US8148356 | Acetylcysteine composition and uses therefor |
21 May, 2026
(3 months ago)
| Expired |
| US8399445 | Acetylcysteine composition and uses thereof |
24 Aug, 2025
(1 year, 1 day ago)
| Expired |
| US8653061 | Acetylcysteine composition and uses thereof |
24 Aug, 2025
(1 year, 1 day ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Acetadote's drug page
2. Caldolor
Caldolor is protected by 11 patents, out of which 1 has expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11806400 | Injectable ibuprofen formulation |
16 Mar, 2032
(5 years from now)
| Active |
| US9072661 | Injectable ibuprofen formulation |
16 Mar, 2032
(5 years from now)
| Active |
| US9072710 | Injectable ibuprofen formulation |
16 Mar, 2032
(5 years from now)
| Active |
| US9012508 | Administration of intravenous ibuprofen |
14 Sep, 2030
(4 years from now)
| Active |
| US8735452 | Treating patients with intravenous ibuprofen |
30 Sep, 2029
(3 years from now)
| Active |
| US8871810 | Treating critically ill patients with intravenous ibuprofen |
30 Sep, 2029
(3 years from now)
| Active |
| US9114068 | Treating patients with intravenous ibuprofen |
30 Sep, 2029
(3 years from now)
| Active |
| US9138404 | Treating critically ill patients with intravenous ibuprofen |
30 Sep, 2029
(3 years from now)
| Active |
| US9295639 | Treating critically ill patients with intravenous ibuprofen |
30 Sep, 2029
(3 years from now)
| Active |
| US9649284 | Treating critically ill patients with intravenous ibuprofen |
30 Sep, 2029
(3 years from now)
| Active |
| US6727286 | Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid |
27 Nov, 2021
(4 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Caldolor's drug page
3. Evdi
Evdi is protected by 1 patent, which is still active. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US12303506 | Trabectedin Composition |
18 Feb, 2043
(16 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Evdi's drug page
4. Ivra
Ivra is protected by 1 patent, which is still active. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US10537520 | Stable liquid formulations of melphalan |
29 Jun, 2036
(9 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Ivra's drug page
5. Paxil
Paxil is protected by 18 patents, out of which all have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US6063927
(Pediatric)
| Paroxetine derivatives |
23 Oct, 2019
(6 years ago)
| Expired |
| US6063927 | Paroxetine derivatives |
23 Apr, 2019
(7 years ago)
| Expired |
| US6172233
(Pediatric)
| Process for making paroxetine |
15 Jul, 2018
(8 years ago)
| Expired |
| US6172233 | Process for making paroxetine |
15 Jan, 2018
(8 years ago)
| Expired |
| US6121291
(Pediatric)
| Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder |
17 Sep, 2017
(8 years ago)
| Expired |
| US6121291 | Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder |
17 Mar, 2017
(9 years ago)
| Expired |
| US5811436
(Pediatric)
| Oral liquid compositions containing paroxetine resinate |
22 Mar, 2016
(10 years ago)
| Expired |
| US5872132
(Pediatric)
| Form of paroxetine hydrochloride anhydrate |
19 Nov, 2015
(10 years ago)
| Expired |
| US5900423
(Pediatric)
| Form of paroxetine hydrochloride anhydrate |
19 Nov, 2015
(10 years ago)
| Expired |
| US6080759
(Pediatric)
| Paroxetine hydrochloride form A |
19 Nov, 2015
(10 years ago)
| Expired |
| US6133289
(Pediatric)
| Paroxetine hydrochloride form A or C |
19 Nov, 2015
(10 years ago)
| Expired |
| US5811436 | Oral liquid compositions containing paroxetine resinate |
22 Sep, 2015
(10 years ago)
| Expired |
| US6113944
(Pediatric)
| Paroxetine tablets and process to prepare them |
14 Jun, 2015
(11 years ago)
| Expired |
| US5872132 | Form of paroxetine hydrochloride anhydrate |
19 May, 2015
(11 years ago)
| Expired |
| US5900423 | Form of paroxetine hydrochloride anhydrate |
19 May, 2015
(11 years ago)
| Expired |
| US6080759 | Paroxetine hydrochloride form A |
19 May, 2015
(11 years ago)
| Expired |
| US6133289 | Paroxetine hydrochloride form A or C |
19 May, 2015
(11 years ago)
| Expired |
| US6113944 | Paroxetine tablets and process to prepare them |
14 Dec, 2014
(11 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Paxil's drug page
Explore Our Curated Drug Screens
6. Paxil Cr
Paxil Cr is protected by 13 patents, out of which all have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US6121291
(Pediatric)
| Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder |
17 Sep, 2017
(8 years ago)
| Expired |
| US6121291 | Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder |
17 Mar, 2017
(9 years ago)
| Expired |
| US6548084
(Pediatric)
| Controlled release compositions |
19 Jan, 2017
(9 years ago)
| Expired |
| US7229640
(Pediatric)
| Paroxetine controlled release compositions |
19 Jan, 2017
(9 years ago)
| Expired |
| US6548084 | Controlled release compositions |
19 Jul, 2016
(10 years ago)
| Expired |
| US7229640 | Paroxetine controlled release compositions |
19 Jul, 2016
(10 years ago)
| Expired |
| US5872132
(Pediatric)
| Form of paroxetine hydrochloride anhydrate |
19 Nov, 2015
(10 years ago)
| Expired |
| US5900423
(Pediatric)
| Form of paroxetine hydrochloride anhydrate |
19 Nov, 2015
(10 years ago)
| Expired |
| US6133289
(Pediatric)
| Paroxetine hydrochloride form A or C |
19 Nov, 2015
(10 years ago)
| Expired |
| US5872132 | Form of paroxetine hydrochloride anhydrate |
19 May, 2015
(11 years ago)
| Expired |
| US5900423 | Form of paroxetine hydrochloride anhydrate |
19 May, 2015
(11 years ago)
| Expired |
| US6133289 | Paroxetine hydrochloride form A or C |
19 May, 2015
(11 years ago)
| Expired |
| US5422123
(Pediatric)
| Tablets with controlled-rate release of active substances |
06 Dec, 2012
(13 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Paxil Cr's drug page
7. Sancuso
Sancuso is protected by 1 patent, which has expired already. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US7608282 | Transdermal granisetron |
22 Jan, 2025
(1 year, 7 months ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Sancuso's drug page
8. Vaprisol
Vaprisol is protected by 1 patent, which has expired already. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US5723606 | Condensed benzazepine derivative and pharmaceutical composition thereof |
15 Dec, 2019
(6 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Vaprisol's drug page
9. Vaprisol In 5% Dextrose In Plastic Container
Vaprisol In 5% Dextrose In Plastic Container is protected by 1 patent, which has expired already. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US5723606 | Condensed benzazepine derivative and pharmaceutical composition thereof |
15 Dec, 2019
(6 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Vaprisol In 5% Dextrose In Plastic Container's drug page
10. Vibativ
Vibativ is protected by 11 patents, out of which 10 have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US7531623 | Hydrochloride salts of a glycopeptide phosphonate derivative |
01 Jan, 2027
(4 months from now)
| Active |
| US6635618 | Glycopeptide phosphonate derivatives |
11 Sep, 2023
(2 years ago)
| Expired |
| US6858584 | Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin |
24 Aug, 2022
(4 years ago)
| Expired |
| US6872701 | Glycopeptide phosphonate derivatives |
05 Jun, 2021
(5 years ago)
| Expired |
| US7008923 | Glycopeptide phosphonate derivatives |
06 May, 2021
(5 years ago)
| Expired |
| US7208471 | Glycopeptide phosphonate derivatives |
01 May, 2021
(5 years ago)
| Expired |
| US7351691 | Glycopeptide phosphonate derivatives |
01 May, 2021
(5 years ago)
| Expired |
| US7544364 | Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin |
01 May, 2021
(5 years ago)
| Expired |
| US7700550 | Glycopeptide phosphonate derivatives |
01 May, 2021
(5 years ago)
| Expired |
| US8101575 | Glycopeptide phosphonate derivatives |
01 May, 2021
(5 years ago)
| Expired |
| US8158580 | Pharmaceutical compositions containing a glycopeptide antibiotic and a cyclodextrin |
01 May, 2021
(5 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Vibativ's drug page