TACROLIMUS - Generic Drug Details

What are the generic sources for tacrolimus and what is the scope of patent protection?

Tacrolimus is the generic ingredient in five branded drugs marketed by Astellas, Chengdu, Accord Hlthcare, Alkem Labs Ltd, Belcher, Biocon Pharma, Concord Biotech Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hangzhou Zhongmei, Heritage Pharma Avet, Mylan, Panacea, Sandoz, Strides Pharma, Hospira, Leo Pharma As, Encube, Fougera Pharms Inc, and Veloxis Pharms Inc, and is included in twenty-five NDAs. There are twenty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tacrolimus has sixty-six patent family members in twenty-four countries.

There are twenty drug master file entries for tacrolimus. Thirty-five suppliers are listed for this compound.

Summary for TACROLIMUS

International Patents:	66
US Patents:	22
Tradenames:	5
Applicants:	20
NDAs:	25
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	1,308
Patent Applications:	7,060
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for TACROLIMUS
Drug Sales Revenues:	Drug sales revenues for TACROLIMUS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TACROLIMUS
What excipients (inactive ingredients) are in TACROLIMUS?	TACROLIMUS excipients list
DailyMed Link:	TACROLIMUS at DailyMed

See drug prices for TACROLIMUS

See drug sales revenues for TACROLIMUS

Recent Clinical Trials for TACROLIMUS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jiangsu Renocell Biotech Company	Phase 2
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Phase 2
Zhishui Chen	Phase 4

See all TACROLIMUS clinical trials

Pharmacology for TACROLIMUS

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for TACROLIMUS

Calcineurin Inhibitors

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for TACROLIMUS

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

L04AD	Calcineurin inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for TACROLIMUS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENVARSUS XR	Extended-release Tablets	tacrolimus	0.75 mg, 1 mg and 4 mg	206406	1	2022-03-31
ASTAGRAF XL	Extended-release Capsules	tacrolimus	0.5 mg, 1 mg, and 5 mg	204096	1	2013-09-24
PROTOPIC	Ointment	tacrolimus	0.03%	050777	1	2010-11-22
PROTOPIC	Ointment	tacrolimus	0.10%	050777	1	2010-09-09

US Patents and Regulatory Information for TACROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No			Y
Astellas	PROGRAF	tacrolimus	FOR SUSPENSION;ORAL	210115-002	May 24, 2018		RX	Yes	Yes
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	AB	RX	Yes	No
Glenmark Pharms Ltd	TACROLIMUS	tacrolimus	CAPSULE;ORAL	206662-003	Nov 10, 2020	AB	RX	No	No
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes
Glenmark Pharms Ltd	TACROLIMUS	tacrolimus	CAPSULE;ORAL	206662-002	Nov 10, 2020	AB	RX	No	No
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No

Expired US Patents for TACROLIMUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000

EU/EMA Drug Approvals for TACROLIMUS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Modigraf	tacrolimus	EMEA/H/C/000954 Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.	Authorised	no	no	no	2009-05-15
Astellas Pharma Europe BV	Advagraf	tacrolimus	EMEA/H/C/000712 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	no	no	no	2007-04-23
Chiesi Farmaceutici S.p.A.	Envarsus	tacrolimus	EMEA/H/C/002655 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	no	no	no	2014-07-18
LEO Pharma A/S	Protopic	tacrolimus	EMEA/H/C/000374 Flare treatmentAdults and adolescents (16 years of age and above)Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.Children (two years of age and above)Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatmentMaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).	Authorised	no	no	no	2002-02-27
Teva B.V.	Tacforius	tacrolimus	EMEA/H/C/004435 Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.	Authorised	yes	no	no	2017-12-08
Astellas Pharma GmbH	Protopy	tacrolimus	EMEA/H/C/000375 Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).	Withdrawn	no	no	no	2002-02-28

International Patents for TACROLIMUS

Country	Patent Number	Title	Estimated Expiration
Canada	2537044	DISPERSIONS SOLIDES COMPRENANT DU TACROLIMUS (SOLID DISPERSIONS COMPRISING TACROLIMUS)
Canada	2688381	FORME PHARMACEUTIQUE ORALE A ADMINISTRER UNE FOIS PAR JOUR COMPORTANT DU TACROLIMUS (ONCE DAILY ORAL DOSAGE FORM COMPRISING TACROLIMUS)
World Intellectual Property Organization (WIPO)	2008145143
Norway	334986
Taiwan	I510238
Denmark	1663217
Japan	2011251972	PHARMACEUTICAL COMPOSITION COMPRISING TACROLIMUS