Assertio Speclty Drug Patent Portfolio
Assertio Speclty owns 4 orange book drugs protected by 39 US patents Given below is the list of Assertio Speclty's drug patents along with their expiration dates.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11541002 | Oral film compositions and dosage forms having precise active dissolution profiles | 31 Jan, 2040 | Active |
| US12290597 | Oral Film Compositions And Dosage Forms Having Precise Active Dissolution Profiles | 05 Sep, 2039 | Active |
| US12403090 | Oral Film Compositions And Dosage Forms Having Precise Active Dissolution Profiles | 05 Sep, 2039 | Active |
| US8814834 | Injector safety device | 27 May, 2031 | Active |
| US11497753 | Hazardous agent injection system | 19 Mar, 2030 | Active |
| US12357642 | Hazardous Agent Injection System | 19 Mar, 2030 | Active |
| US8480631 | Hazardous agent injection system | 19 Mar, 2030 | Active |
| US8579865 | Hazardous agent injection system | 19 Mar, 2030 | Active |
| US8945063 | Hazardous agent injection system | 19 Mar, 2030 | Active |
| US9421333 | Hazardous agent injection system | 19 Mar, 2030 | Active |
| US10709844 | Injector safety device | 10 Mar, 2029 | Active |
| US11684723 | Injector safety device | 10 Mar, 2029 | Active |
| US9867949 | Injector safety device | 10 Mar, 2029 | Active |
| US7662858 | Method of treating post-surgical acute pain | 24 Feb, 2029 | Active |
| US7884095 | Method of treating post-surgical acute pain | 24 Feb, 2029 | Active |
| US7939518 | Method of treating post-surgical acute pain | 24 Feb, 2029 | Active |
| US8110606 | Method of treating post-surgical acute pain | 24 Feb, 2029 | Active |
| US8623920 | Method of treating post-surgical acute pain | 24 Feb, 2029 | Active |
| US9561200 | Method of treating post-surgical acute pain | 24 Feb, 2029 | Active |
| US8021335 | Prefilled syringe jet injector | 04 Oct, 2026 | Active |
| US7759394 | Diclofenac formulations and methods of use | 16 Jun, 2026 | Active |
| US8097651 | Diclofenac formulations and methods of use | 16 Jun, 2026 | Active |
| US8927604 | Diclofenac formulations and methods of use | 16 Jun, 2026 | Active |
| US9827197 | Diclofenac formulations and methods of use | 16 Jun, 2026 | Active |
| US11446441 | Prefilled syringe injector | 24 Jan, 2026 | Expired |
| US8562564 | Prefilled syringe jet injector | 24 Jan, 2026 | Expired |
| US9533102 | Prefilled syringe jet injector | 24 Jan, 2026 | Expired |
| US9629959 | Prefilled syringe jet injector | 24 Jan, 2026 | Expired |
| US8603514 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions | 03 Apr, 2024 | Expired |
| US8765167 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions | 20 Feb, 2024 | Expired |
| US6746429 | Needle assisted jet injector | 12 Apr, 2020 | Expired |
| US7744582 | Needle assisted jet injector | 10 Aug, 2019 | Expired |
| US7776015 | Needle assisted jet injector | 10 Aug, 2019 | Expired |
| USRE44846 | Needle assisted jet injector | 10 Aug, 2019 | Expired |
| USRE44847 | Needle assisted jet injector | 10 Aug, 2019 | Expired |
| US6365180 | Oral liquid compositions | 15 Jul, 2019 | Expired |
| US6287594 | Oral liquid compositions | 15 Jan, 2019 | Expired |
| US6974595 | Pharmaceutical compositions based on Diclofenae | 15 May, 2017 | Expired |
| US7482377 | Pharmaceutical compositions and methods of treatment based on diclofenac | 15 May, 2017 | Expired |
Latest Legal Activities on Assertio Speclty's Drug Patents
Given below is the list of recent legal activities going on the following drug patents of Assertio Speclty.
| Activity | Date | Patent Number |
|---|---|---|
| ||
| Recordation of Patent Grant Mailed | 09 Sep, 2025 | US12403090 |
| Recordation of Patent eGrant | 02 Sep, 2025 | US12403090 |
| Patent eGrant Notification | 02 Sep, 2025 | US12403090 |
| Patent Issue Date Used in PTA Calculation | 02 Sep, 2025 | US12403090 |
| Mail Patent eGrant Notification | 02 Sep, 2025 | US12403090 |
| Issue Notification Mailed | 20 Aug, 2025 | US12403090 |
| Maintenance Fee Reminder Mailed | 28 Jul, 2025 | US8603514 (Litigated) |
| Application Is Considered Ready for Issue | 25 Jul, 2025 | US12403090 |
| Dispatch to FDC | 25 Jul, 2025 | US12403090 |
| Mail Response to 312 Amendment (PTO-271) | 23 Jul, 2025 | US12403090 |
| Response to Amendment under Rule 312 | 22 Jul, 2025 | US12403090 |
| Recordation of Patent Grant Mailed | 22 Jul, 2025 | US12357642 |
| Email Notification | 16 Jul, 2025 | US12357642 |
| Patent eGrant Notification | 15 Jul, 2025 | US12357642 |
| Mail Patent eGrant Notification | 15 Jul, 2025 | US12357642 |
Assertio Speclty's Drug Patent Litigations
Assertio Speclty's drugs have been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 28, 2014, against patent number US8765167. The petitioner BioDelivery Sciences International, Inc., challenged the validity of this patent, with MonoSol Rx, LLC. et al. as the respondent. Click below to track the latest information on how companies are challenging Assertio Speclty's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
| ||||
| US8603514 | June, 2017 |
Institution Denied
(20 Oct, 2017)
| MonoSol Rx, LLC et al. | Par Pharmaceutical, Inc. et al. |
| US8603514 | June, 2017 |
Institution Denied
(20 Oct, 2017)
| MonoSol Rx, LLC et al. | Dr. Reddy’s Laboratories, Inc. et al. |
| US8603514 | November, 2016 |
Terminated-Settled
(06 Oct, 2017)
| MonoSol Rx, LLC et al. | Mylan Technologies, Inc. et al. |
| US8603514 | May, 2016 |
Institution Denied
(05 Dec, 2016)
| MonoSol Rx, LLC et al. | Dr. Reddy's Laboratories, Inc. et al. |
| US8603514 | December, 2015 |
Institution Denied
(23 May, 2016)
| MONOSOL RX LLC et al. | Teva Pharmaceuticals USA Inc |
| US8765167 | October, 2014 |
Final Written Decision
(24 Mar, 2016)
| MonoSol Rx, LLC. et al. | BioDelivery Sciences International, Inc. |
| US8765167 | October, 2014 |
Terminated-Settled
(24 Mar, 2016)
| MonoSol Rx, LLC. et al. | BioDelivery Sciences International, Inc. |
| US8765167 | October, 2014 |
Institution Denied
(20 May, 2015)
| MonoSol Rx, LLC. et al. | BioDelivery Sciences International, Inc. |
Assertio Speclty Drug Patents' Oppositions Filed in EPO
Assertio Speclty drug patents have faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 11, 2012, by Lts Lohmann Therapie-Systeme Ag. This opposition was filed on patent number EP02801042A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| |||
| EP19150366A | Sep, 2022 | Bandpay & Greuter | Granted and Under Opposition |
| EP06719329A | Oct, 2019 | Bandpay & Greuter | Patent maintained as amended |
| EP09719763A | Jun, 2016 | Ypsomed AG | Revoked |
| EP11157819A | Jun, 2014 | Ahrens, Gabriele | Patent maintained as amended |
| EP02782151A | Jun, 2013 | Acino Pharma AG | Revoked |
| EP02782151A | Jun, 2013 | Germann, Sandra | Revoked |
| EP02801042A | Sep, 2012 | Ahrens, Gabriele | Patent maintained as amended |
| EP02801042A | Sep, 2012 | LTS LOHMANN Therapie-Systeme AG | Patent maintained as amended |
Assertio Speclty's Family Patents
Assertio Speclty Drug List
Given below is the complete list of Assertio Speclty's drugs and the patents protecting them.
1. Cambia
Cambia is protected by 6 patents, out of which 2 have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US7759394 | Diclofenac formulations and methods of use |
16 Jun, 2026
(2 months from now)
| Active |
| US8097651 | Diclofenac formulations and methods of use |
16 Jun, 2026
(2 months from now)
| Active |
| US8927604 | Diclofenac formulations and methods of use |
16 Jun, 2026
(2 months from now)
| Active |
| US9827197 | Diclofenac formulations and methods of use |
16 Jun, 2026
(2 months from now)
| Active |
| US6974595 | Pharmaceutical compositions based on Diclofenae |
15 May, 2017
(8 years ago)
| Expired |
| US7482377 | Pharmaceutical compositions and methods of treatment based on diclofenac |
15 May, 2017
(8 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 Cambia's drug page
2. Otrexup
Otrexup is protected by 20 patents, out of which 9 have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US8814834 | Injector safety device |
27 May, 2031
(5 years from now)
| Active |
| US11497753 | Hazardous agent injection system |
19 Mar, 2030
(3 years from now)
| Active |
| US12357642 | Hazardous Agent Injection System |
19 Mar, 2030
(3 years from now)
| Active |
| US8480631 | Hazardous agent injection system |
19 Mar, 2030
(3 years from now)
| Active |
| US8579865 | Hazardous agent injection system |
19 Mar, 2030
(3 years from now)
| Active |
| US8945063 | Hazardous agent injection system |
19 Mar, 2030
(3 years from now)
| Active |
| US9421333 | Hazardous agent injection system |
19 Mar, 2030
(3 years from now)
| Active |
| US10709844 | Injector safety device |
10 Mar, 2029
(2 years from now)
| Active |
| US11684723 | Injector safety device |
10 Mar, 2029
(2 years from now)
| Active |
| US9867949 | Injector safety device |
10 Mar, 2029
(2 years from now)
| Active |
| US8021335 | Prefilled syringe jet injector |
04 Oct, 2026
(6 months from now)
| Active |
| US11446441 | Prefilled syringe injector |
24 Jan, 2026
(a month ago)
| Expired |
| US8562564 | Prefilled syringe jet injector |
24 Jan, 2026
(a month ago)
| Expired |
| US9533102 | Prefilled syringe jet injector |
24 Jan, 2026
(a month ago)
| Expired |
| US9629959 | Prefilled syringe jet injector |
24 Jan, 2026
(a month ago)
| Expired |
| US6746429 | Needle assisted jet injector |
12 Apr, 2020
(5 years ago)
| Expired |
| US7744582 | Needle assisted jet injector |
10 Aug, 2019
(6 years ago)
| Expired |
| US7776015 | Needle assisted jet injector |
10 Aug, 2019
(6 years ago)
| Expired |
| USRE44846 | Needle assisted jet injector |
10 Aug, 2019
(6 years ago)
| Expired |
| USRE44847 | Needle assisted jet injector |
10 Aug, 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 Otrexup's drug page
3. Sympazan
Sympazan is protected by 5 patents, out of which 2 have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11541002 | Oral film compositions and dosage forms having precise active dissolution profiles |
31 Jan, 2040
(13 years from now)
| Active |
| US12290597 | Oral Film Compositions And Dosage Forms Having Precise Active Dissolution Profiles |
05 Sep, 2039
(13 years from now)
| Active |
| US12403090 | Oral Film Compositions And Dosage Forms Having Precise Active Dissolution Profiles |
05 Sep, 2039
(13 years from now)
| Active |
| US8603514 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
03 Apr, 2024
(1 year, 11 months ago)
| Expired |
| US8765167 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
20 Feb, 2024
(2 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 Sympazan's drug page
4. Zipsor
Zipsor is protected by 8 patents, out of which 2 have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US7662858 | Method of treating post-surgical acute pain |
24 Feb, 2029
(2 years from now)
| Active |
| US7884095 | Method of treating post-surgical acute pain |
24 Feb, 2029
(2 years from now)
| Active |
| US7939518 | Method of treating post-surgical acute pain |
24 Feb, 2029
(2 years from now)
| Active |
| US8110606 | Method of treating post-surgical acute pain |
24 Feb, 2029
(2 years from now)
| Active |
| US8623920 | Method of treating post-surgical acute pain |
24 Feb, 2029
(2 years from now)
| Active |
| US9561200 | Method of treating post-surgical acute pain |
24 Feb, 2029
(2 years from now)
| Active |
| US6365180 | Oral liquid compositions |
15 Jul, 2019
(6 years ago)
| Expired |
| US6287594 | Oral liquid compositions |
15 Jan, 2019
(7 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 Zipsor's drug page