Drugs With Orange Book Exclusivities Expiring In 2026

In 2026, more than 160 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 2026, marking an important moment for both manufacturers and consumers.

1. JENTADUETO

Jentadueto is a brand drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for treating type 2 diabetes mellitus. It was approved for market use on Jan 30, 2012. Jentadueto uses Linagliptin; Metformin Hydrochloride as an active ingredient.

Total Patents: 26
Expired Patents: 9

Jentadueto holds 7 exclusivities. Out of these M-295, PED will expire in 2026. Given below is the list of all its exclusivities and their expiration dates

Exclusivity Code Exclusivity Date
M-252 Mar 30, 2023
M-146 Jul 30, 2017
M-295 Jun 20, 2026
M-258 Jul 03, 2022
PED Dec 20, 2026
NCE May 02, 2016
NC Jan 30, 2015

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

2. ORENITRAM

Orenitram is a brand drug owned by United Therapeutics Corp. It is Used for treating pulmonary arterial hypertension (WHO Group 1) with oral osmotic pharmaceutical dosage forms of treprostinil. It was approved for market use on Dec 20, 2013. Orenitram uses Treprostinil Diolamine as an active ingredient.

Total Patents: 16
Expired Patents: 7

Orenitram holds 6 exclusivities. Out of these ODE-272 will expire in 2026. Given below is the list of all its exclusivities and their expiration dates

Exclusivity Code Exclusivity Date
D-157 Jan 28, 2019
D-156 Jan 28, 2019
ODE-308 Dec 20, 2020
I-820 Oct 18, 2022
ODE-272 Oct 18, 2026
NDF Dec 20, 2016

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

3. BRUKINSA

Brukinsa is a brand drug owned by Beone Medicines Usa Inc. It is used for treating adult patients with various types of lymphomas and leukemias who have not responded to prior therapies. It was approved for market use on Nov 14, 2019. Brukinsa uses Zanubrutinib as an active ingredient.

Total Patents: 13
Expired Patents: 0

Brukinsa holds 11 exclusivities. Out of these I-817, ODE-276 will expire in 2026. Given below is the list of all its exclusivities and their expiration dates

Exclusivity Code Exclusivity Date
ODE-371 Aug 31, 2028
I-817 Jan 19, 2026
ODE* Mar 07, 2031
ODE-467 Mar 07, 2031
I-936 Mar 07, 2027
ODE-274 Jan 19, 2030
I-871 Aug 31, 2024
I-874 Sep 14, 2024
ODE-370 Sep 14, 2028
NCE Nov 14, 2024
ODE-276 Nov 14, 2026

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

4. ZEPBOUND (AUTOINJECTOR)

Zepbound (autoinjector) is a brand drug owned by Eli Lilly And Co. It is Used for long-term weight management in adults who are overweight or obese with at least one weight-related comorbid condition. It was approved for market use on Nov 8, 2023. Zepbound (autoinjector) uses Tirzepatide as an active ingredient.

Total Patents: 8
Expired Patents: 0

Zepbound (autoinjector) holds 4 exclusivities. Out of these NP will expire in 2026. Given below is the list of all its exclusivities and their expiration dates

Exclusivity Code Exclusivity Date
NP Nov 08, 2026
NCE May 13, 2027
M-82 Oct 18, 2027
I-958 Dec 20, 2027

Check the entire list of patents and their expiration dates for Zepbound (autoinjector)

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: 26
Expired Patents: 0

Jardiance holds 11 exclusivities. Out of these PED, NPP, I-922 will expire in 2026. 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
PED Dec 20, 2026
I-739 Dec 02, 2019
I-869 Aug 18, 2024
NPP Jun 20, 2026
M-161 Jun 26, 2018
I-922 Sep 21, 2026
M-82 Feb 24, 2025
M-159 Jun 26, 2018
M-174 Mar 18, 2019

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

6. EXPAREL

Exparel is a brand drug owned by Pacira Pharmaceuticals Inc. It is Used for providing local or regional analgesia in various surgical procedures and postoperative pain management. It was approved for market use on Oct 28, 2011. Exparel uses Bupivacaine as an active ingredient.

Total Patents: 26
Expired Patents: 5

Exparel holds 4 exclusivities. Out of these I-929 will expire in 2026. Given below is the list of all its exclusivities and their expiration dates

Exclusivity Code Exclusivity Date
I-771 Apr 06, 2021
I-929 Nov 09, 2026
NPP Mar 22, 2024
NP Oct 28, 2014

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

7. BOSULIF

Bosulif is a brand drug owned by Pf Prism Cv. It is used for treating BCR-ABL positive leukemia resistant to imatinib, including patients with specific BCR-ABL mutations and various phases of CML. It was approved for market use on Sep 4, 2012. Bosulif uses Bosutinib Monohydrate as an active ingredient.

Total Patents: 11
Expired Patents: 5

Bosulif holds 9 exclusivities. Out of these NP, I-923 will expire in 2026. Given below is the list of all its exclusivities and their expiration dates

Exclusivity Code Exclusivity Date
ODE-30 Sep 04, 2019
ODE-444 Sep 26, 2030
NP Sep 26, 2026
ODE-163 Dec 19, 2024
PED Mar 26, 2027
I-923 Sep 26, 2026
I-759 Dec 19, 2020
ODE Sep 04, 2019
NCE Sep 04, 2017

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

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