Drugs With Orange Book Exclusivities Expiring In 2025
In 2025, more than 140 drugs will reach the end of their Orange Book exclusivities. These exclusivities have protected these medications from generic competition, but as they expire, it opens the door for generics to enter the market. This could lead to more affordable options for patients and significant shifts in the pharmaceutical industry. On this page, we list the drugs whose exclusivities are set to expire in 2025, marking an important moment for both manufacturers and consumers.
1. ARMONAIR RESPICLICK
Armonair Respiclick is a brand drug owned by Teva Pharmaceutical Industries Ltd. It was approved for market use on Jul 9, 2021. Armonair Respiclick uses Fluticasone Propionate as an active ingredient.
Total Patents:
35
Expired Patents:
9
Armonair Respiclick holds 4 exclusivities. Out of these PED will expire in 2025. Given below is the list of all its exclusivities and their expiration dates
| Exclusivity Code | Exclusivity Date |
|---|---|
| PED | Jan 09, 2025 |
| NP | Jan 27, 2020 |
| NPP | Jul 09, 2024 |
| NS | Jul 09, 2024 |
Check the entire list of patents and their expiration dates for Armonair Respiclick
2. PROCYSBI
Procysbi is a brand drug owned by Horizon Therapeutics Usa Inc. It is Used for treating nephropathic cystinosis. It was approved for market use on Apr 30, 2013. Procysbi uses Cysteamine Bitartrate as an active ingredient.
Total Patents:
25
Expired Patents:
0
Procysbi holds 9 exclusivities. Out of these PED will expire in 2025. Given below is the list of all its exclusivities and their expiration dates
| Exclusivity Code | Exclusivity Date |
|---|---|
| ODE* | Dec 22, 2024 |
| PED | Jun 22, 2025 |
| NDF | Apr 30, 2016 |
| ODE | Aug 14, 2022 |
| NPP | Aug 14, 2018 |
| M-216 | Dec 22, 2020 |
| ODE-162 | Dec 22, 2024 |
| ODE-97 | Aug 14, 2022 |
| ODE-45 | Apr 30, 2020 |
Check the entire list of patents and their expiration dates for Procysbi
3. COPIKTRA
Copiktra is a brand drug owned by Secura Bio Inc. It is Used for treating chronic lymphocytic leukemia, small lymphocytic leukemia, and follicular lymphoma. It was approved for market use on Sep 24, 2018. Copiktra uses Duvelisib as an active ingredient.
Total Patents:
5
Expired Patents:
0
Copiktra holds 3 exclusivities. Out of these ODE-209, ODE-208 will expire in 2025. Given below is the list of all its exclusivities and their expiration dates
| Exclusivity Code | Exclusivity Date |
|---|---|
| NCE | Sep 24, 2023 |
| ODE-209 | Sep 24, 2025 |
| ODE-208 | Sep 24, 2025 |
Check the entire list of patents and their expiration dates for Copiktra
4. BYDUREON PEN
Bydureon Pen is a brand drug owned by Astrazeneca Ab. It is used for improving glycemic control in patients with Type 2 diabetes, reducing food intake, delaying gastric motility, reducing body weight, and stimulating insulin release. It was approved for market use on Feb 28, 2014. Bydureon Pen uses Exenatide Synthetic as an active ingredient.
Total Patents:
60
Expired Patents:
19
Bydureon Pen holds 4 exclusivities. Out of these PED will expire in 2025. Given below is the list of all its exclusivities and their expiration dates
| Exclusivity Code | Exclusivity Date |
|---|---|
| PED | Jan 22, 2025 |
| M-224 | Apr 02, 2021 |
| M-240 | Feb 15, 2022 |
| NPP | Jul 22, 2024 |
Check the entire list of patents and their expiration dates for Bydureon Pen
5. JARDIANCE
Jardiance is a brand drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is Used for reducing cardiovascular risk and treating type 2 diabetes, heart failure, and chronic kidney disease with empagliflozin. It was approved for market use on Aug 1, 2014. Jardiance uses Empagliflozin as an active ingredient.
Total Patents:
18
Expired Patents:
0
Jardiance holds 11 exclusivities. Out of these M-82 will expire in 2025. Given below is the list of all its exclusivities and their expiration dates
| Exclusivity Code | Exclusivity Date |
|---|---|
| M-160 | Jun 26, 2018 |
| NCE | Aug 01, 2019 |
| NPP | Jun 20, 2026 |
| M-161 | Jun 26, 2018 |
| I-922 | Sep 21, 2026 |
| M-159 | Jun 26, 2018 |
| M-174 | Mar 18, 2019 |
| M-82 | Feb 24, 2025 |
| PED | Dec 20, 2026 |
| I-869 | Aug 18, 2024 |
| I-739 | Dec 02, 2019 |
Check the entire list of patents and their expiration dates for Jardiance
6. FINTEPLA
Fintepla is a brand drug owned by Ucb Inc. It is used for reducing or ameliorating seizures in patients with Dravet or Lennox-Gastaut syndrome through various combination therapies and cardiac monitoring to mitigate cardiovascular risk. It was approved for market use on Jun 25, 2020. Fintepla uses Fenfluramine Hydrochloride as an active ingredient.
Total Patents:
28
Expired Patents:
0
Fintepla holds 5 exclusivities. Out of these I-887 will expire in 2025. Given below is the list of all its exclusivities and their expiration dates
| Exclusivity Code | Exclusivity Date |
|---|---|
| PED | Sep 25, 2029 |
| ODE-312 | Jun 25, 2027 |
| NP | Jun 25, 2023 |
| ODE-393 | Mar 25, 2029 |
| I-887 | Mar 25, 2025 |
Check the entire list of patents and their expiration dates for Fintepla