Pharsight

1. Beleodaq patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6888027	ACROTECH	Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors	Aug, 2026 (2 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8835501	ACROTECH	Pharmaceutical formulations of HDAC inhibitors	Oct, 2027 (4 years from now)

Market Authorisation Date: 03 July, 2014

Treatment: Treatment of patients with relapsed or refractory peripheral t-cell lymphoma (ptcl).

Dosage: POWDER;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
500 mg/vial	03 Jul, 2018	1		27 Oct, 2027

Strength	Dosage	Availability
500MG/VIAL	POWDER;INTRAVENOUS	Prescription

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).
US8410077	ACROTECH	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (5 years from now)
US9200088	ACROTECH	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (5 years from now)
US10864183	ACROTECH	Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same	May, 2030 (6 years from now)
US11020363	ACROTECH	Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same	May, 2030 (6 years from now)
US10940128	ACROTECH	Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same	Jun, 2030 (6 years from now)
US9493582	ACROTECH	Alkylated cyclodextrin compositions and processes for preparing and using the same	Feb, 2033 (9 years from now)
US10040872	ACROTECH	Alkylated cyclodextrin compositions and processes for preparing and using the same	Jan, 2034 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Mar 10, 2023

Market Authorisation Date: 10 March, 2016

Treatment: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma

Dosage: POWDER;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg/vial	08 Sep, 2017	1	06 Mar, 2020	27 Feb, 2033	Eligible

Strength	Dosage	Availability
EQ 50MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6028071	ACROTECH	Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors	Jul, 2022 (1 year, 2 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7622470	ACROTECH	Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin	May, 2025 (1 year, 8 months from now)
US8299078	ACROTECH	Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin	May, 2025 (1 year, 8 months from now)

Market Authorisation Date: 24 September, 2009

Treatment: Treatment of patients with relapsed or refractory peripheral t-cell lymphoma

Dosage: SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
20 mg/mL and 40 mg/2 mL	24 Sep, 2013	4		31 May, 2025

Strength	Dosage	Availability
20MG/ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription
40MG/2ML (20MG/ML)	SOLUTION;INTRAVENOUS	Prescription

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US6500829	March, 1998	Decision	WOOD et al

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6500829	ACROTECH	Substantially pure diastereoisomers of tetrahydrofolate derivatives	Mar, 2022 (1 year, 6 months ago)

Market Authorisation Date: 07 March, 2008

Treatment: NA

Dosage: POWDER;INTRAVENOUS; SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
10 mg/mL, 17.5 mL vial and 25 mL vial	26 Oct, 2011	1	09 Mar, 2015	31 Dec, 2019	Eligible
50 mg/vial	19 Dec, 2013	1