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. It is available from two suppliers. 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. Forty-three 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

Pharmacology for NDA: 201922

Medical Subject Heading (MeSH) Categories for 201922

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 201922

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922	NDA	Journey Medical Corporation	69489-121	69489-121-03	3 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (69489-121-03)
XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922	NDA	Journey Medical Corporation	69489-121	69489-121-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69489-121-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 45MG BASE
Approval Date:	Jul 11, 2012	TE:		RLD:	No
Patent:	⤷ Try a Trial	Patent Expiration:	Apr 2, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Patent:	⤷ Try a Trial	Patent Expiration:	Apr 2, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 24, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACNE

Expired US Patents for NDA 201922

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

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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 verification 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.