Pharsight

1. Carbatrol patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5912013	TAKEDA PHARMS USA	Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine	Jun, 2016 (7 years ago)

Market Authorisation Date: 30 September, 1997

Treatment: Neurological and other disorders (treatment of epilepsy, bid oral dosing)

Dosage: CAPSULE, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg and 200 mg	02 Feb, 2006	1		15 Jun, 2016	Extinguished
300 mg

Strength	Dosage	Availability
200MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
300MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
100MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription

CARBATROL family patents

2. Carnexiv patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP06816054A	2015-02-06	Actavis Group PTC ehf	Revoked

Patent	Proceeding Filing Date	Status	Respondent

US9770407	December, 2014	Decision	Lundbeck Pharmaceuticals LLC
US9629797	July, 2014	Decision	James Cloyd et al

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9770407	LUNDBECK PHARMS LLC	Parenteral carbamazepine formulation	Nov, 2028 (4 years from now)
US9629797	LUNDBECK PHARMS LLC	Parenteral carbamazepine formulation	Nov, 2028 (4 years from now)
US7635773	LUNDBECK PHARMS LLC	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9750822	LUNDBECK PHARMS LLC	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US8410077	LUNDBECK PHARMS LLC	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9493582	LUNDBECK PHARMS LLC	Alkylated cyclodextrin compositions and processes for preparing and using the same	Feb, 2033 (8 years from now)
US11529357	LUNDBECK PHARMS LLC	Injectable carbamazepine composition essentially free of 10-bromo-carbamazepine	Jan, 2040 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE)	Oct 07, 2023
Orphan Drug Exclusivity(ODE-124)	Oct 07, 2023

Market Authorisation Date: 07 October, 2016

Treatment: Replacement therapy for oral carbamazepine in adults with mixed seizure patterns that include partial seizures with complex symptomatology, generalized tonic-clonic seizures, or other partial or gener...

Dosage: SOLUTION;INTRAVENOUS

Strength	Dosage	Availability
200MG/20ML (10MG/ML)	SOLUTION;INTRAVENOUS	Discontinued

CARNEXIV family patents

3. Equetro patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5912013	VALIDUS PHARMS	Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine	Jun, 2016 (7 years ago)
US6977253	VALIDUS PHARMS	Methods for the treatment of bipolar disorder using carbamazepine	May, 2024 (23 days from now)

Market Authorisation Date: 10 December, 2004

Treatment: The recommended initial dose of equetro is 400mg/day given in divided doses, twice daily. the dose should be adjusted in 200mg daily increments to achieve optimal clinical response.