Pharsight

1. Astagraf Xl 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).
US6440458	ASTELLAS	Sustained release preparations	Mar, 2019 (5 years ago)
US6576259	ASTELLAS	Sustained release formulations containing tacrolimus	Mar, 2019 (5 years ago)
US8551522	ASTELLAS	Sustained-release formulation	Mar, 2019 (5 years ago)
US6884433	ASTELLAS	Sustained release formulation containing tacrolimus	Mar, 2019 (5 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
ODE(ODE)	May 24, 2025
New Dosage Form(NDF)	Jul 19, 2016

Market Authorisation Date: 19 July, 2013

Treatment: Method of once a day administration

Dosage: CAPSULE, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.5 mg, 1 mg, and 5 mg	24 Sep, 2013	1		25 Mar, 2019	Extinguished

Strength	Dosage	Availability
EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
EQ 5MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
EQ 1MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription

ASTAGRAF XL family patents

2. Envarsus Xr 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).
US7994214	VELOXIS PHARMS INC	Solid dispersions comprising tacrolimus	Aug, 2024 (4 months from now)
US8486993	VELOXIS PHARMS INC	Solid dispersions comprising tacrolimus	Aug, 2024 (4 months from now)
US8586084	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US8889186	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US8623411	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US8889185	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US9161907	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US8617599	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US8623410	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US11077096	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US10548880	VELOXIS PHARMS INC	Solid dispersions comprising tacrolimus	Aug, 2024 (4 months from now)
US9763920	VELOXIS PHARMS INC	Solid dispersions comprising tacrolimus	Aug, 2024 (4 months from now)
US9757362	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US8591946	VELOXIS PHARMS INC	Modified release compositions comprising tacrolimus	Aug, 2024 (4 months from now)
US10166190	VELOXIS PHARMS INC	Stabilized tacrolimus composition	May, 2028 (4 years from now)
US11110081	VELOXIS PHARMS INC	Tacrolimus for improved treatment of transplant patients	May, 2028 (4 years from now)
US10864199	VELOXIS PHARMS INC	Tacrolimus for improved treatment of transplant patients	May, 2028 (4 years from now)
US11419823	VELOXIS PHARMS INC	Stabilized tacrolimus composition	May, 2028 (4 years from now)
US9549918	VELOXIS PHARMS INC	Stabilized tacrolimus composition	May, 2028 (4 years from now)
US11123331	VELOXIS PHARMS INC	Tacrolimus for improved treatment of transplant patients	May, 2028 (4 years from now)
US8644239	VELOXIS PHARMS INC	Method and apparatus for allocating and processing sequences in communication system	Aug, 2028 (4 years from now)
US8664239	VELOXIS PHARMS INC	Tacrolimus for improved treatment of transplant patients	Aug, 2028 (4 years from now)
US8685998	VELOXIS PHARMS INC	Tacrolimus for improved treatment of transplant patients	Aug, 2028 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE)	Jul 10, 2022
Orphan Drug Exclusivity(ODE-94)	Jul 10, 2022

Market Authorisation Date: 10 July, 2015

Treatment: Prophylaxis of organ rejection; Prophylaxis of organ rejection in de novo transplant patient; Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.75 mg, 1 mg and 4 mg	31 Mar, 2022	1		30 May, 2028

Strength	Dosage	Availability
EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 0.75MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription

ENVARSUS XR family patents

3. Protopic 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).
US5665727	LEO PHARMA AS	Use of 11,28-dioxa-4-azatricyclo[22.3.1.04,9 ]octacos-18-ene derivatives and pharmaceutical compositions containing them	Sep, 2014 (9 years ago)

Market Authorisation Date: 08 December, 2000

Treatment: For the treatment of dermatitis

Dosage: OINTMENT;TOPICAL

Pharsight

Drugs that contain Tacrolimus

1. Astagraf Xl patents expiration

ASTAGRAF XL family patents

2. Envarsus Xr patents expiration

ENVARSUS XR family patents

3. Protopic patents expiration

PROTOPIC family patents

Related content

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.0003	22 Nov, 2010	1	09 Sep, 2014	09 Sep, 2014	Extinguished
0.001	09 Sep, 2010	1	09 Sep, 2014	09 Sep, 2014	Extinguished

Strength	Dosage	Availability
0.03%	OINTMENT;TOPICAL	Prescription
0.1%	OINTMENT;TOPICAL	Prescription