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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

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 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.

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Drug patent expirations by year for PROTOPIC
Drug Prices for PROTOPIC

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Drug Sales Revenue Trends for PROTOPIC

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Recent Clinical Trials for PROTOPIC

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

SponsorPhase
Blood and Marrow Transplant Clinical Trials NetworkPhase 2
National Marrow Donor ProgramPhase 2
National Heart, Lung, and Blood Institute (NHLBI)Phase 2

See all PROTOPIC clinical trials

Pharmacology for PROTOPIC
Paragraph IV (Patent) Challenges for PROTOPIC
Tradename Dosage Ingredient NDA Submissiondate
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-11-22
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 050777-001 Dec 8, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
McKinsey
Johnson and Johnson
Express Scripts
Moodys

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