PROTOPIC Drug Patent Profile

Which patents cover Protopic, and when can generic versions of Protopic launch?

Protopic is a drug marketed by Leo Pharma As and is included in one NDA.

The generic ingredient in PROTOPIC is tacrolimus. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Protopic

A generic version of PROTOPIC was approved as tacrolimus by SANDOZ on August 10^th, 2009.

Summary for PROTOPIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	110
Drug Prices:	Drug price information for PROTOPIC
Drug Sales Revenues:	Drug sales revenues for PROTOPIC
What excipients (inactive ingredients) are in PROTOPIC?	PROTOPIC excipients list
DailyMed Link:	PROTOPIC at DailyMed

See drug prices for PROTOPIC

See drug sales revenues for PROTOPIC

Recent Clinical Trials for PROTOPIC

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 1
Children's Oncology Group	Phase 3
Johns Hopkins University	Phase 3

See all PROTOPIC clinical trials

Pharmacology for PROTOPIC

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Paragraph IV (Patent) Challenges for PROTOPIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 PROTOPIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-001	Dec 8, 2000	AB	RX	Yes	Yes
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000	AB	RX	Yes	Yes

Expired US Patents for PROTOPIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-001	Dec 8, 2000
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-001	Dec 8, 2000

EU/EMA Drug Approvals for PROTOPIC

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 PROTOPIC

See the table below for patents covering PROTOPIC around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	677448
Sweden	519137	Ny användning av azatricykloderivat och farmaceutiska kompositioner innehållande desamma
Spain	2099112
Hong Kong	1000006
United Kingdom	8826066
Hungary	211470
Japan	H01157913	NOVEL USE OF AZATRICYCLOCTACOSENE DERIVATIVE