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: 17

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

7. KALYDECO

Kalydeco is a brand drug owned by Vertex Pharmaceuticals Inc. It is used for treating Cystic Fibrosis by targeting specific CFTR mutations with Ivacaftor treatment. It was approved for market use on Jan 31, 2012. Kalydeco uses Ivacaftor as an active ingredient.

Total Patents: 13
Expired Patents: 0

Kalydeco holds 15 exclusivities. Out of these ODE-199 will expire in 2025. Given below is the list of all its exclusivities and their expiration dates

Exclusivity Code Exclusivity Date
ODE-190 May 17, 2024
ODE-338 Dec 21, 2027
I-740 Feb 21, 2017
ODE-189 Jul 31, 2024
NPP May 03, 2026
ODE-435 May 03, 2030
ODE-199 Aug 15, 2025
ODE Jan 31, 2019
ODE-188 Mar 17, 2022
NCE Jan 31, 2017
ODE-236 Apr 29, 2026
ODE-20 Jan 31, 2019
ODE-187 Dec 29, 2021
ODE-186 Feb 21, 2021
I-705 Dec 30, 2017

Check the entire list of patents and their expiration dates for Kalydeco

Download full list of 140+ drugs as PDF

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