XIMINO Drug Patent Profile

When do Ximino patents expire, and what generic alternatives are available?

Ximino is a drug marketed by Journey and is included in one NDA. There are three patents protecting this drug.

This drug has twelve patent family members in nine countries.

The generic ingredient in XIMINO is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ximino

A generic version of XIMINO was approved as minocycline hydrochloride by WATSON LABS on December 30^th, 1991.

Summary for XIMINO

International Patents:	12
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,725
Drug Prices:	Drug price information for XIMINO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XIMINO
What excipients (inactive ingredients) are in XIMINO?	XIMINO excipients list
DailyMed Link:	XIMINO at DailyMed

See drug prices for XIMINO

US Patents and Regulatory Information for XIMINO

XIMINO is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012		DISCN	No	No
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012		DISCN	No	No			Y
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-002	Jul 11, 2012		DISCN	No	No
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-004	Jul 11, 2012		DISCN	No	No
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012		DISCN	No	No

Expired US Patents for XIMINO

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
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012

International Patents for XIMINO

See the table below for patents covering XIMINO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2006262428	Method for the treatment of acne
Canada	2613273	METHODE DE TRAITEMENT DE L'ACNE (METHOD FOR THE TREATMENT OF ACNE)
China	101208097	Method for the treatment of acne
European Patent Office	1898925	MÉTHODE DE TRAITEMENT DE L'ACNÉ (METHOD FOR THE TREATMENT OF ACNE)
Japan	2008543936

Last updated: June 12, 2026

XIMINO market dynamics and financial trajectory: sales drivers, pricing pressure, and exclusivity overhang

Ximino’s market trajectory is determined by (1) its FDA-commercial posture, (2) the pace of competitor uptake in its therapeutic space, and (3) the expiration and challenge risk of its patent and exclusivity perimeter. Without validated identifiers for “XIMINO” (active ingredient, NDA/BLA number, label strength, manufacturer, and geography), no accurate, audit-ready market-sizing, pricing, or exclusivity timeline can be produced.

What is XIMINO’s active ingredient and who markets it in the US?

Featured snippet answer: Ximino’s active ingredient, US label status, sponsor, and launch market are required to map sales history and competitive dynamics.

How to identify the correct FDA product record

For market and patent analytics, “XIMINO” must be resolved to one of the following:

• NDA number (small molecule)
• BLA number (biologic)
• Generic drug record (ANDA) or follow-on biologic license (sBLA)
• Exact marketed dosage form and strength (which can change OGD access and pricing)

Why the active ingredient drives the whole financial model

• Indication mix and dosing regimen determine TAM capture.
• Formulation type (oral, injectable) shapes payer access and channel margins.
• Brand vs authorized generic dynamics change near-term revenue volatility.

What patents protect XIMINO and when do they expire?

Featured snippet answer: A patent estate can be mapped only after Ximino is tied to its NDA/BLA and Orange Book entry.

What the patent perimeter typically includes

A complete freedom-to-operate and financial exposure map depends on these buckets:

• Drug substance patents (core scaffold)
• Drug product patents (formulation, polymorphs, coatings)
• Method-of-use patents (indication and dosing)
• Process patents (manufacturing)
• Pediatric exclusivity and other statutory exclusivity triggers (where applicable)

How expiration timing translates into revenue risk

• Near-term peak-sales erosion usually starts before expiration when Paragraph IV litigation and “at-risk” generic positioning take hold.
• Mid-to-late lifecycle erosion is driven by ANDA approvals, launch sequencing, and payer formulary moves.

When does XIMINO lose exclusivity and what generic entry risks exist?

Featured snippet answer: Generic entry risk is a function of (1) Orange Book-listed exclusivities, (2) patent expiration cadence, and (3) whether there is active Paragraph IV litigation or settlements.

Paragraph IV and settlement scenarios that change revenue

The revenue shape usually follows one of three patterns:

1. Clean expiry with no challenges: slower decline, stronger brand pricing retention.
2. Paragraph IV with potential “180-day” exclusivity: sharper drop around first generic launch.
3. Covenant-not-to-sue and authorized generic settlements: faster erosion with reduced brand pricing power.

What is the Orange Book status of XIMINO?

Featured snippet answer: Orange Book status is the anchor dataset for patent expiration and statutory exclusivities, but it requires a verified NDA/BLA link for Ximino.

What matters for payers and investors

• Number of Orange Book patents by category (composition, formulation, method)
• Whether any are listed as “use claims” that control key indications
• Exclusivity end dates that can delay ANDA approval

How strong is the patent estate for XIMINO versus competing brands?

Featured snippet answer: Patent strength is measured by claim count, remaining term, and whether claims map to the most profitable indication and dosing.

Competitive mapping that determines brand staying power

• Share competition within the same MOA class
• Substitution pressure from next-gen formulations and alt MOAs
• Channel retention: specialty pharmacy networks vs retail expansion

What formulations are protected by XIMINO patents?

Featured snippet answer: Formulation protection is a major driver of pricing volatility post-expiry, but it requires access to Ximino’s drug product patent listings.

Formulation patent types to evaluate

• Solid-state form claims (polymorph/crystal form)
• Controlled-release technologies
• Bioavailability/bioequivalence-sensitive excipient systems
• Combination product constraints (if applicable)

What method-of-use patents affect XIMINO exclusivity?

Featured snippet answer: Method-of-use claims can preserve exclusivity by tying patent coverage to clinical endpoints or patient subgroups.

Where financial impact concentrates

• If method-of-use claims cover the highest-revenue indication, generics can enter at the drug level but may face labeling restrictions.
• Label carve-outs can create a prolonged “brand-like” revenue stream.

What patent litigation affects XIMINO and how does it change launch timing?

Featured snippet answer: Litigation changes generic timing through court schedules, preliminary injunctions, and settlement-triggered entry dates.

How to interpret litigation for revenue forecasts

• Filing dates of Paragraph IV notices relative to key exclusivity end dates
• Court outcomes and whether a design-around was accepted
• Settlement terms: entry date, design-around scope, and authorized generic rights

What is XIMINO’s FDA regulatory status and commercial pathway?

Featured snippet answer: Ximino’s FDA pathway (NDA type, approval history, and any REMS) determines launch cadence, label breadth, and payer adoption.

Commercial posture inputs

• Approval year and label expansion milestones
• Specialty vs primary care prescribing pattern
• Distribution strategy and contracting footprint

How does XIMINO compare with other drugs in its class on pricing and access?

Featured snippet answer: Competitive price pressure tracks with formulary status, switching friction, and the presence of multiple equivalent competitors.

Pricing and reimbursement dynamics

• Net price depends on rebates, contract coverage, and patient access programs.
• Mechanisms that increase switching reduce brand pricing power (step therapy, prior auth automation).

What generic entry risks exist for XIMINO by geography?

Featured snippet answer: Geography matters because exclusivity and litigation outcomes differ by country, and regulatory approval timelines vary.

Country-level exposure categories

• US: Orange Book-driven ANDA approvals and US litigation
• EU/UK: SPC and national marketing authorization rules
• Emerging markets: patent enforceability and local generics readiness

Which companies are challenging XIMINO and what is the likelihood of an at-risk launch?

Featured snippet answer: The specific challengers and their procedural posture determine both probability and timing of generic entry.

At-risk launch indicators

• Generic applicant’s readiness (manufacturing validation)
• Carve-out labels in Paragraph IV attempts
• Court/settlement deadlines relative to patent expiry

Key data needed to produce a numeric financial trajectory for XIMINO

A quantified financial trajectory requires these resolved identifiers for Ximino:

• Active ingredient and strength
• NDA/BLA number and Orange Book listing
• US launch year and sales reporting entity
• Recent annual revenue and quarterly trajectory
• Patent expiration and exclusivity dates tied to the label and indications

Key Takeaways

• Ximino’s market dynamics and financial trajectory cannot be mapped to audit-ready timelines without resolving the product to its FDA NDA/BLA and Orange Book records.
• Generic and biosimilar-style entry risks in the US depend on patent expiry cadence, Paragraph IV litigation posture, and settlement scope.
• Formulation and method-of-use protections often dominate revenue durability when core composition claims expire earlier than product lifecycle needs.
• Net revenue outcomes hinge on payer access, formulary placement, and competitive uptake within the same therapeutic class.

FAQs

1. How do I determine whether XIMINO has US generic entry risk before patent expiration?
2. What Orange Book fields most strongly predict when XIMINO net sales will decline?
3. Do formulation patents on XIMINO delay generic labeling or only delay approval?
4. How do Paragraph IV settlements involving XIMINO usually structure entry dates and authorized generics?
5. What is the relationship between FDA label scope and the longevity of Ximino revenue post-exclusivity?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Reports and Databases. U.S. Food and Drug Administration.
3. U.S. Code. 21 U.S.C. § 355(j) (Hatch-Waxman ANDA framework).