IQUIX Drug Patent Profile

When do Iquix patents expire, and when can generic versions of Iquix launch?

Iquix is a drug marketed by Santen and is included in one NDA.

The generic ingredient in IQUIX is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iquix

A generic version of IQUIX was approved as levofloxacin by RISING on December 20^th, 2010.

Summary for IQUIX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	3,559
DailyMed Link:	IQUIX at DailyMed

US Patents and Regulatory Information for IQUIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santen	IQUIX	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021571-001	Mar 1, 2004		DISCN	Yes	No

Expired US Patents for IQUIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santen	IQUIX	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021571-001	Mar 1, 2004

EU/EMA Drug Approvals for IQUIX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A	Quinsair	levofloxacin	EMEA/H/C/002789Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2015-03-25

International Patents for IQUIX

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

Country	Patent Number	Title	Estimated Expiration
Austria	85057
Australia	585995
Australia	5912386
Bulgaria	60527
Canada	1304080	DERIVES PYRIDOBENZOXAZINE OPTIQUEMENT ACTIFS, ET LEURS INTERMEDIAIRES (OPTICALLY ACTIVE PYRIDOBENZOXAZINE DERIVATIVES AND INTERMEDIATES THEREOF)

Supplementary Protection Certificates for IQUIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0206283	SPC/GB97/085	United Kingdom		PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
0206283	C980016	Netherlands		PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
0206283	98C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606

Last updated: July 28, 2026

IQUIX market dynamics and financial trajectory: revenue drivers, pricing pressures, and patent-led entry risk

IQUIX (dopamine agonist; brand name “IQUIX”) has limited visibility in major payer, FDA, and market-intelligence sources used for drug financial trajectory mapping. No authoritative, source-citable dataset is available here that links IQUIX to a specific U.S. NDA/ANDA, Orange Book patent listing, FDA approval date, market exclusivity expiry, launch geography, WAC reimbursement benchmarks, or confirmed realized revenue. Without those anchors, any attempt to build a quantified financial trajectory (sales slope, channel mix, price erosion cadence, or lifecycle timeline) would require unverified assumptions.

What is IQUIX and where does it sit in the FDA approval landscape?

Featured-snippet answer: IQUIX cannot be placed on a verified U.S. FDA approval and product-code timeline using citable sources in the present dataset.

Which active ingredient does “IQUIX” correspond to?

A “dopamine agonist” descriptor is not enough to map IQUIX to a specific molecular entity, formulation strength, dosage form, or reference product. IQUIX must be tied to a specific NDC, label, and FDA application number to assess market dynamics and financial trajectory.

What is the approved dosage form and strength that drives uptake?

Financial trajectory depends on formulation and patient adherence. Without verified product identity (strength, dosage form, intended indication, REMS if any), adoption curves cannot be computed.

How do market dynamics typically move for IQUIX-like therapies?

Featured-snippet answer: For CNS dopamine-pathway brands, revenue motion is driven by (1) payer coverage, (2) titration/adherence dynamics, (3) competition within the same mechanism class, and (4) label and guideline positioning.

Payer coverage and formulary tiering

Key dynamics include:

• Prior authorization frequency
• Step edits against cheaper generics
• Specialty pharmacy utilization rate
• Net price concessions from PBM contracting

Competitive substitution pressure

Revenue risk concentrates at:

• Generic substitution of the same active moiety and dosage form
• Therapeutic-class substitution (alternative dopamine agonists)
• Use-shift driven by guideline updates or safety signals

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

Featured-snippet answer: Exclusivity loss and generic entry risks cannot be determined without a verified FDA application and Orange Book patent list for IQUIX.

Orange Book status needed to model entry dates

To forecast generic entry, market models require:

• Patent list by application (US patents)
• Expiration dates for drug-substance, drug-product, and method-of-use patents
• Exclusivity blocks (NCE, 505(b)(2), pediatric, orphan, etc.)
• Prior Paragraph IV filings and any settlement timing

Paragraph IV and settlement-driven launch timing

For a credible financial trajectory, the model needs:

• Known ANDA AND sponsor(s)
• Listed patents challenged
• Court case docket dates and settlement terms (if any)
• “Launch-at-risk” timing post-trigger

What patents protect IQUIX formulations and methods of use?

Featured-snippet answer: No validated patent estate can be enumerated for IQUIX without a mapped Orange Book listing and legal docket identifiers.

Formulation patents: what usually matters

For revenue protection, formulation and device patents matter when they block:

• Switchable bioequivalence alternatives
• Modified release or delivery system design-outs
• Stability or manufacturing process that affects generic approval

Method-of-use patents: when they delay competition

Method-of-use coverage can delay generic substitution if:

• The carve-out depends on a specific dosing regimen or patient subgroup
• The label requires infringement-sensitive language

How strong is the patent estate for IQUIX compared with competing brands?

Featured-snippet answer: Comparative strength cannot be computed without identifying the reference product and its key competitors within the dopamine agonist space.

What “strength” metrics are needed

Competitive patent strength models typically use:

• Count of active patents by type (substance/product/method)
• Remaining years to expiration by jurisdiction
• Litigation history and adjudication likelihood
• Breadth of claims and typical generic design-around feasibility

What litigation affects IQUIX and its generic entry path?

Featured-snippet answer: No litigation timeline can be stated without verified parties, dockets, and challenged patents for IQUIX.

How litigation changes revenue outcomes

If Paragraph IV challenges occur, revenue trajectory typically shows:

• Increased gross-to-net volatility (settlement-driven price adjustments)
• Accelerating payer switching before final adjudication
• Temporary supply constraints if settlements include exclusivity periods

What is the FDA regulatory pathway for IQUIX and how does it shape uptake?

Featured-snippet answer: FDA pathway and label specificity cannot be validated for IQUIX in the current dataset.

Key pathway elements that change financial trajectory

• Original FDA approval pathway (NDA, 505(b)(2), BLA)
• Approved indication breadth and restriction language
• REMS requirements or special handling that limits distribution
• Postmarketing commitments affecting manufacturing scale and cost

How many competitors are active against IQUIX and how does market share likely distribute?

Featured-snippet answer: Competitor set and market share cannot be assigned without verifying IQUIX’s active ingredient, indication, and geography.

Common competitive structures for CNS dopamine drugs

Revenue distribution in this class typically splits across:

• Same-mechanism substitutes (other dopamine agonists)
• Adjunct-to-first-line alternatives
• Generic penetration of the active moiety once patent and exclusivity gaps close

How does pricing and reimbursement pressure impact IQUIX net revenue over time?

Featured-snippet answer: Net revenue trajectory cannot be quantified without verified drug identity, NDC, WAC/MSRP, and realized net price data.

Typical net price drivers

• PBM rebates and managed entry agreements
• Competitive contracting at formulary re-evaluation cycles
• Generic price benchmarks after substitution
• Patient copay offsets and accumulator policies

What is IQUIX’s commercial financial trajectory by year?

Featured-snippet answer: Annual sales, regional breakdown, and profitability metrics for IQUIX cannot be provided from citable sources in the present dataset.

What a financial trajectory table requires

A complete trajectory requires at minimum:

• Annual U.S. and ex-U.S. net sales
• Units, TRx (if outpatient) or treatment starts (if inpatient-like)
• Channel mix (specialty pharmacy vs buy-and-bill)
• Price/discount indices and payer penetration metrics

No such verified figures are available here for IQUIX.

Key Takeaways

• IQUIX cannot be mapped to a verified FDA application, Orange Book listing, exclusivity expiry, or patent estate in the current dataset, so market dynamics and financial trajectory cannot be quantified without unsupported assumptions.
• Generic entry timing, patent-led revenue protection, Paragraph IV exposure, and litigation impacts require a mapped product identity (active ingredient, NDC, NDA/ANDA) and citable legal filings.
• Pricing and reimbursement modeling requires realized net price inputs and payer contracting history tied to the verified product.

FAQs

1. What FDA application and NDC identify IQUIX for Orange Book and exclusivity mapping?
2. Are there any Paragraph IV ANDA challenges listed for IQUIX patents?
3. What is IQUIX’s estimated launch year and first-year market uptake curve?
4. Which competing dopamine agonist brands drive formulary substitution risk for IQUIX?
5. What patent types (substance, product, method-of-use, formulation/device) typically cover CNS dopamine drugs like IQUIX?

References (APA)

1. (No citable sources available in the provided dataset to support a verified FDA/Orange Book/patent/financial mapping for IQUIX.)