Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Medtronic
AstraZeneca
Harvard Business School
Moodys

Last Updated: November 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050777

See Plans and Pricing

« Back to Dashboard

NDA 050777 describes PROTOPIC, which is a drug marketed by Leo Pharma As and is included in one NDA. It is available from three suppliers. Additional details are available on the PROTOPIC profile page.

The generic ingredient in PROTOPIC is tacrolimus. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.
Summary for 050777
Tradename:PROTOPIC
Applicant:Leo Pharma As
Ingredient:tacrolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050777
Mechanism of ActionCalcineurin Inhibitors
Medical Subject Heading (MeSH) Categories for 050777
Suppliers and Packaging for NDA: 050777
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROTOPIC tacrolimus OINTMENT;TOPICAL 050777 NDA Astellas Pharma US Inc. 0469-5201 0469-5201-02 1 TUBE in 1 CARTON (0469-5201-02) > 2 g in 1 TUBE
PROTOPIC tacrolimus OINTMENT;TOPICAL 050777 NDA Astellas Pharma US Inc. 0469-5201 0469-5201-11 1 TUBE in 1 CARTON (0469-5201-11) > 100 g in 1 TUBE
Paragraph IV (Patent) Challenges for 050777
Tradename Dosage Ingredient NDA Submissiondate
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-11-22
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-09-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.03%
Approval Date:Dec 8, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.1%
Approval Date:Dec 8, 2000TE:ABRLD:Yes

Expired US Patents for NDA 050777

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Johnson and Johnson
Mallinckrodt
Express Scripts
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.