Carbamazepine Patent Expiration

Carbamazepine is Used for treating neurological and other disorders such as epilepsy with twice daily oral dosing. It was first introduced by Novartis Pharmaceuticals Corp in its drug Tegretol on Approved Prior to Jan 1, 1982. Other drugs containing Carbamazepine are Carbatrol, Carnexiv, Tegretol-Xr, Equetro. 38 different companies have introduced drugs containing Carbamazepine.


Carbamazepine Patents

Given below is the list of patents protecting Carbamazepine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Carnexiv US11529357 Injectable carbamazepine composition essentially free of 10-bromo-carbamazepine Jan 31, 2040 Lundbeck Pharms Llc
Carnexiv US9493582 Alkylated cyclodextrin compositions and processes for preparing and using the same Feb 27, 2033 Lundbeck Pharms Llc
Carnexiv US7635773 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Lundbeck Pharms Llc
Carnexiv US8410077 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Lundbeck Pharms Llc
Carnexiv US9750822 Sulfoalkyl ether cyclodextrin compositions Mar 13, 2029 Lundbeck Pharms Llc
Carnexiv US9629797 Parenteral carbamazepine formulation Nov 10, 2028 Lundbeck Pharms Llc
Carnexiv US9770407 Parenteral carbamazepine formulation Nov 10, 2028 Lundbeck Pharms Llc
Equetro US6977253 Methods for the treatment of bipolar disorder using carbamazepine May 19, 2024

(Expired)

Validus Pharms
Carbatrol US5912013 Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine Jun 15, 2016

(Expired)

Takeda Pharms Usa
Equetro US5912013 Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine Jun 15, 2016

(Expired)

Validus Pharms



Carbamazepine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Carbamazepine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Verducatib in the Blood Boehringer Ingelheim NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults Astellas Pharma Global Development, Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together Otsuka Pharmaceutical Development & Commercialization, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants Eisai Inc. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
A Trial of Lu AH69593 in Healthy Participants H. Lundbeck A/S NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants Eli Lilly and Company NA COMPLETED
(Jun 1, 2026)
PHASE1
A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants Incyte Corporation NA COMPLETED
(Jun 1, 2026)
PHASE1
A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women Otsuka Pharmaceutical Development & Commercialization, Inc. NA COMPLETED
(Jun 1, 2026)
PHASE1
Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole Acesion Pharma NA COMPLETED
(May 1, 2026)
PHASE1
To Evaluate Efficacy of Monotherapy of Oxcarbazepine Versus Combination of Gabapentin With Oxcarbazepine in the Management of Trigeminal Neuralgia Rehman Medical Institute - RMI NA COMPLETED
(May 1, 2026)
PHASE2, PHASE3
Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN University of Alberta NA RECRUITING
(Apr 1, 2026)
PHASE2
Drug-Drug Interaction Study of Atumelnant in Healthy Participants Crinetics Pharmaceuticals Inc. NA COMPLETED
(Apr 1, 2026)
PHASE1
A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144 Pfizer NA COMPLETED
(Mar 1, 2026)
PHASE1
To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany NA COMPLETED
(Mar 1, 2026)
PHASE1


Carbamazepine Generic API Manufacturers

Several generic applications have been filed for Carbamazepine. The first generic version for Carbamazepine was by Usl Pharma Inc and was approved on May 15, 1986. And the latest generic version is by Alembic Pharmaceuticals Ltd and was approved on Jul 25, 2025.

Given below is the list of companies who have filed for Carbamazepine generic, along with the locations of their manufacturing plants worldwide.


Carbamazepine News

Market for Generic Medications: Integration of Personalized Medicine and Pharmacogenomic Guidance...

23 Mar, 2026

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18 Jan, 2024

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