VERKAZIA Drug Patent Profile

Which patents cover Verkazia, and what generic alternatives are available?

Verkazia is a drug marketed by Harrow Eye and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and fifteen patent family members in twenty-three countries.

The generic ingredient in VERKAZIA is cyclosporine. There are eighteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Verkazia

A generic version of VERKAZIA was approved as cyclosporine by HIKMA on October 29^th, 1999.

Summary for VERKAZIA

International Patents:	115
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	89
Patent Applications:	7,031
Drug Prices:	Drug price information for VERKAZIA
What excipients (inactive ingredients) are in VERKAZIA?	VERKAZIA excipients list
DailyMed Link:	VERKAZIA at DailyMed

See drug prices for VERKAZIA

Pharmacology for VERKAZIA

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for VERKAZIA

VERKAZIA is protected by seven US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes	11,612,658
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes	8,524,779		Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes	9,220,694		Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes	8,298,568		Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes	9,132,071		Y

Expired US Patents for VERKAZIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021	9,220,694
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021	11,612,658
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021	8,524,779
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021	9,956,289
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021	7,973,081

International Patents for VERKAZIA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2007278141
Canada	2659322
China	101534791
Cyprus	1114457
Cyprus	1118148
Cyprus	1118436

Supplementary Protection Certificates for VERKAZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049079	PA2017003	Lithuania		PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
2049079	LUC00006	Luxembourg		PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323
2049079	PA2017003,C2049079	Lithuania		PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
1809237	C300741	Netherlands		PRODUCT NAME: CICLOSPORINE (EYE DROP; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237	CA 2015 00030	Denmark		PRODUCT NAME: CYCLOSPORINOEJENDRABEEMULSION; REG. NO/DATE: EU/1/15/990/001-002 20150319
1809237	122015000043	Germany		PRODUCT NAME: OPHTHALMISCHE EMULSION ENTHALTEND CYCLOSPORIN; REGISTRATION NO/DATE: EU/1/15/990 20150319

Last updated: June 15, 2026

VERKAZIA (vericiguat) Market Dynamics and Financial Trajectory: Sales Drivers, Pricing, Competition, and Patent-Runway Impact

Executive summary: VERKAZIA (vericiguat) has a commercialization profile shaped by (1) cardiovascular risk-segmentation and payer coverage for high-risk heart failure populations, (2) competitive pressure from guideline-directed medical therapy (GDMT) and class peers, and (3) exclusivity and patent runway that determines when generic or biosimilar-like disruption (if applicable) can occur. The exact sales trajectory, payer mix, and revenue inflection points depend on VERKAZIA’s FDA label scope, launch timing by geography, and the status of Orange Book-protected patents and any ANDA/Paragraph IV challenges. No drug sales or patent status facts are provided in the prompt, so a complete, accurate market-and-financial trajectory cannot be produced.

What are the market dynamics driving VERKAZIA (vericiguat) sales today?

Featured snippet answer: Market dynamics for VERKAZIA typically depend on how tightly its FDA label maps to high-risk heart failure criteria, formulary adoption speed among commercial payers, and real-world adherence and dosing persistence in target patients.

Which patient segments do payers cover first

• High-risk cardiovascular populations tend to receive the earliest formulary placement when the label narrows to patients with recent decompensation or elevated risk markers.
• Coverage outcomes depend on:
  • line of therapy (add-on to GDMT versus earlier use),
  • eligibility criteria alignment with payer clinical programs,
  • step-edit requirements (prior authorization, quantity limits).

Formulary status and utilization management

• Commercial payers commonly use tiering plus step edits for non-first-line heart failure drugs.
• Hospital or integrated delivery networks may influence early adoption if discharge pathways include VERKAZIA for eligible patients.

Channel and contracting structure

• Revenue dynamics usually reflect:
  • PBM-managed formularies and rebate intensity,
  • specialty pharmacy versus retail distribution (if applicable),
  • outcomes-based contracting when payers demand evidence against comparators.

How does VERKAZIA compare with competing heart failure therapies on uptake and payer friction?

Featured snippet answer: Uptake for VERKAZIA is usually highest where prescribers see clear incremental benefit versus existing GDMT and where payer policy does not impose multi-step utilization controls.

Competitive set: which drug classes create substitution risk

• Typical substitution pressure comes from:
  • ARNI/ACEI/ARB backbone therapies,
  • beta-blockers,
  • SGLT2 inhibitors,
  • MRAs,
  • other heart failure add-ons with overlapping patient criteria.

Where VERKAZIA can win on clinical positioning

• If the label emphasizes high-risk or post-events use, VERKAZIA can gain adoption in post-hospitalization and early follow-up.
• If the label emphasizes broader chronic use, competition shifts toward long-term persistence and formulary placement.

What matters most for switching behavior

• Dosing convenience, titration schedule, and monitoring burden drive persistence.
• Safety signals that trigger step therapy or increased denials can depress net sales even with stable gross demand.

When does VERKAZIA lose exclusivity and create generic entry risk?

Featured snippet answer: Generic entry risk is determined by the Orange Book listed patents for VERKAZIA, their expiration dates, pediatric exclusivities, and any granted patent term extensions or stayed launches due to litigation.

Exclusivity timeline components that determine launch timing

• Patent expiration (composition, method-of-use, formulation, and device-delivery if any).
• Patent term adjustment (PTA) and patent term extension (PTE).
• Exclusivity protections:
  • non-patent exclusivity (if applicable),
  • pediatric exclusivity,
  • any granted regulatory exclusivities.

Paragraph IV triggers

• The earliest generic opportunity typically follows:
  • first ANDA with Paragraph IV certification,
  • resolution of infringement actions,
  • settlement terms that can delay or accelerate entry.

What patents protect VERKAZIA and how strong is the patent estate?

Featured snippet answer: Patent estate strength is driven by the count of Orange Book-listed patents per NDA and the diversity of claim types, such as composition-of-matter versus method-of-use versus formulation.

How to evaluate strength for litigation and blocking

• Claim breadth: composition versus narrow process claims.
• Claim geography: exclusivity varies by jurisdiction.
• Litigation posture: whether asserted patents are upheld or narrowed.

How strong estates usually translate into revenue protection

• Multi-patent coverage delays ANDA filing incentives and reduces likelihood of early generic wins.
• Method-of-use and formulation patents can block “label carve-outs” or force design-around.

What is the Orange Book status of VERKAZIA (vericiguat)?

Featured snippet answer: Orange Book status is determined by the NDA’s listed active ingredients, dosage forms, and each patent’s expiration date and listed claim scope.

Orange Book data fields to track

• Application number (NDA/BLA reference)
• Active ingredient and dosage form
• Patent numbers, expiration dates, and patent types (drug substance, drug product, method of use)
• Regulatory exclusivity periods

Which companies are challenging VERKAZIA with ANDAs or Paragraph IV certifications?

Featured snippet answer: Paragraph IV challenges, if filed, identify the generic sponsor(s) most likely to pressure net pricing once any launch is permitted.

What to extract from FDA notices

• ANDA filer identity
• Patent numbers challenged
• Certification paragraph (I, II, III, IV)
• Current litigation or stay status, if applicable

What patent litigation affects VERKAZIA and how do settlements change launch timing?

Featured snippet answer: Litigation outcome and settlement structure determine whether generics can launch at the earliest lawful date or must wait through a mutually agreed delayed entry period.

Settlement terms that move revenue

• “Pay-for-delay” style delays (where applicable under legal framework).
• “No-ATB” or other restrictions on launching “at-risk.”
• License terms that may include contingent payments or royalties that extend sponsor revenue.

Court or ITC involvement

• Injunction risk and product launch stays can materially change net sales expectations in the year of first generic entry.

What regulatory pathway issues could affect VERKAZIA utilization and financial performance?

Featured snippet answer: Utilization can shift when FDA label updates expand or narrow eligible populations, or when safety communications affect prescribing and payer coverage.

Label scope and risk of off-label suppression

• If label scope limits eligibility to narrow high-risk phenotypes, sales depend on the real-world ability to correctly identify target patients.
• Safety alerts can reduce adoption even within label.

Post-marketing requirements

• Additional data requests can slow expanded adoption or require formulary re-evaluation.

What generic entry risks exist for VERKAZIA and what design-around barriers apply?

Featured snippet answer: Generic entry risk depends on whether the challenged patents are composition, method-of-use, or formulation, and whether the generic sponsor can meet bioequivalence while avoiding protected claim coverage.

Design-around pathways

• Reformulation to avoid formulation patent claims (if applicable).
• Label design to avoid method-of-use infringement (if allowed and enforceable).
• Manufacturing process changes when process patents exist.

How bioavailability or device differences affect launch

• If product equivalence depends on specific excipients, dissolution specs, or manufacturing conditions, design-around barriers increase.

How does VERKAZIA’s revenue trajectory typically break down: gross sales to net sales?

Featured snippet answer: Net sales trajectory is driven by gross-to-net deductions, payer rebates, chargebacks, and wholesaler inventory movements.

Net revenue dynamics to watch

• Volume versus pricing: generic threats primarily compress pricing; demand growth depends on segment penetration.
• Rebate and payer mix: higher managed-care penetration usually lifts rebate intensity.
• Inventory normalization: quarter-to-quarter swings often reflect stock adjustments rather than demand changes.

What does a launch-and-growth model imply for VERKAZIA financially?

Featured snippet answer: Financial trajectory usually follows a late-stage curve: adoption accelerates during early formulary placements, then moderates as competitors consolidate and utilization management tightens.

Key inflection points that drive yearly sales

• First formulary inclusion in major PBMs
• Uptake in post-acute and outpatient settings
• Safety communications and label updates
• Patent/litigation milestones affecting generic threat

Key Takeaways

• VERKAZIA’s market dynamics are primarily determined by label-to-eligibility alignment, payer formulary speed, and persistence.
• Competitive pressure in heart failure is structural and depends on who owns the highest-share guideline segments.
• The timeline for generic entry hinges on Orange Book patent coverage, litigation outcomes, and any settlement-imposed launch delays.
• Net sales movement is usually the outcome of volume growth tempered by rebates, pricing pressure, and utilization management.

FAQs

1. How fast do PBMs add VERKAZIA after launch, and what rebate levels typically accompany tier changes?
2. Which VERKAZIA patient criteria drive highest adherence and persistence in real-world data?
3. What Orange Book patent types most often block early generic launch for heart failure drugs like VERKAZIA?
4. How do Paragraph IV settlements typically shape “at-risk” launch windows for competitors?
5. What safety or label updates most commonly alter payer coverage and prescribing behavior for VERKAZIA?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drug Trials Snapshots and labeling for approved drug products. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases-drug-trials-snapshots