PROTOPIC Drug Patent Profile
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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-six 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 10th, 2009.
Summary for PROTOPIC
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 80 |
Clinical Trials: | 108 |
Formulation / Manufacturing: | see details |
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 |
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 |
Pharmacology for PROTOPIC
Drug Class | Calcineurin Inhibitor Immunosuppressant |
Mechanism of Action | Calcineurin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for PROTOPIC
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-002 | Dec 8, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for PROTOPIC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-002 | Dec 8, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-002 | Dec 8, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Leo Pharma As | PROTOPIC | tacrolimus | OINTMENT;TOPICAL | 050777-001 | Dec 8, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for PROTOPIC
See the table below for patents covering PROTOPIC around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 8694 | TOPICAL COMPOSITIONS COMPRISING 11,28-DIOXA-4-AZATRICYCLO(22.3.1.0(4,9))OCTACOS-18-ENE DERIVATIVES | ⤷ Try a Trial |
Austria | 407957 | ⤷ Try a Trial | |
Japan | 2604834 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |