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Last Updated: June 4, 2020

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Details for New Drug Application (NDA): 201922


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NDA 201922 describes XIMINO, which is a drug marketed by Journey and is included in one NDA. There are six patents protecting this drug. Additional details are available on the XIMINO profile page.

The generic ingredient in XIMINO is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 201922
Tradename:XIMINO
Applicant:Journey
Ingredient:minocycline hydrochloride
Patents:6
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 201922

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE
Approval Date:Jul 11, 2012TE:RLD:No
Patent:  Start TrialPatent Expiration:Apr 2, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Patent:  Start TrialPatent Expiration:Apr 2, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

Expired US Patents for NDA 201922

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-003 Jul 11, 2012   Start Trial   Start Trial
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-001 Jul 11, 2012   Start Trial   Start Trial
Journey XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-005 Jul 11, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Harvard Business School
Colorcon
AstraZeneca
Merck

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