KYNMOBI Drug Patent Profile

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

Kynmobi is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are twelve patents protecting this drug.

This drug has two hundred and fifty-eight patent family members in twenty-seven countries.

The generic ingredient in KYNMOBI is apomorphine hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the apomorphine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kynmobi

A generic version of KYNMOBI was approved as apomorphine hydrochloride by TP ANDA HOLDINGS on February 23^rd, 2022.

Summary for KYNMOBI

International Patents:	258
US Patents:	12
Applicants:	1
NDAs:	1
Clinical Trials:	1
Patent Applications:	860
Drug Prices:	Drug price information for KYNMOBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYNMOBI
What excipients (inactive ingredients) are in KYNMOBI?	KYNMOBI excipients list
DailyMed Link:	KYNMOBI at DailyMed

See drug prices for KYNMOBI

Recent Clinical Trials for KYNMOBI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
William Ondo, MD	Phase 4
Sunovion	Phase 4

See all KYNMOBI clinical trials

US Patents and Regulatory Information for KYNMOBI

KYNMOBI is protected by twelve US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No	9,326,981
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020		DISCN	Yes	No	9,283,219		Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	11,419,769		Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	9,044,475		Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No	8,846,074		Y
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	9,326,981
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	10,420,763		Y

Expired US Patents for KYNMOBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020	11,077,068
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020	9,855,221
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-002	May 21, 2020	8,765,167
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020	8,663,687
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020	9,855,221
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	8,663,687
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020	9,855,221

International Patents for KYNMOBI

When does loss-of-exclusivity occur for KYNMOBI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KYNMOBI around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010259971
Australia	2017200329
Australia	2019200308
Australia	2021201259
Brazil	112012000204
Canada	2765291
China	102480958

Last updated: April 23, 2026

KYNMOBI (lenadogene nolparvovec): Market dynamics and financial trajectory

KYNMOBI is an AAV-based gene therapy (lenadogene nolparvovec) for an ultra-niche neurologic indication. Its market dynamics are dominated by site-of-care economics, patient-eligibility funnel constraints, payer coverage decisions tied to clinical outcome thresholds, and capacity constraints in centers equipped for gene-transfer workflows. Financial trajectory in the near-to-mid term will track (1) the rate of confirmed treated patients, (2) retention of payer coverage across years, and (3) supply and reimbursement scalability after initial launch-year normalization.

What is the commercial setup behind KYNMOBI’s market dynamics?

KYNMOBI is marketed in the US as a gene therapy under a one-time administration model, pricing typically structured around an upfront total cost of therapy. That pricing structure changes both buyer behavior and reimbursement governance versus recurring-dose products:

• Reimbursement is more policy-driven than product-mix-driven. Payers often evaluate gene therapy under separate medical policy constructs (coverage criteria, evidence requirements, and budget impact gates) rather than on standard drug benefit rails.
• Adoption depends on center readiness. AAV gene therapy workflows require specialized treatment centers for patient screening, pre-treatment evaluation, dosing preparation, and post-treatment monitoring.
• Patient volumes are constrained by eligibility. The addressable market in gene therapy is typically smaller than in chronic pharmacotherapy because eligibility is tied to disease stage, prior treatment history, and required baseline characteristics.

Commercial implication: The “market size” is less about annual disease incidence and more about the fraction of patients who clear eligibility criteria and successfully navigate coverage approval.

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How do patient flow and eligibility constrain near-term demand?

Gene therapy demand is governed by a funnel that compresses the pipeline between diagnosis and treatment. For KYNMOBI, the funnel has four bottlenecks:

1. Diagnosis and referral timing
   • Neurologic gene therapy uptake is shaped by referral patterns to treated centers and time-to-assessment after diagnosis.
2. Eligibility screening
   • Coverage and label-aligned eligibility reduce the fraction of diagnosed patients that can be offered therapy.
3. Payer authorization friction
   • Even with coverage, prior authorization steps and evidence documentation requirements delay initiation and reduce realized demand.
4. Capacity and scheduling
   • Once a center is operational, throughput still depends on staffing, scheduling windows, and monitoring protocols.

Net effect on revenue: Early revenue typically rises with treated-patient counts, not with marketing reach. The product’s financial trajectory therefore depends on scaling treated volume per center and expansion of the eligible treatment network.

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What payer dynamics will shape revenue realization?

For high-cost one-time gene therapies, payer behavior tends to show three recurring patterns:

• Coverage with utilization controls
  • Payers may impose limits based on disease severity bands, prior therapy status, and/or baseline biomarkers.
• Evidence and outcomes documentation
  • Claims adjudication and ongoing review often require outcomes documentation tied to pre-defined endpoints.
• Budget impact management
  • Commercial and Medicaid plans use year-by-year budgeting and utilization projections that can slow adoption when membership mix changes.

Business consequence: Any shift in payer willingness to approve marginal cases will alter the realized demand curve faster than incremental clinical differentiation in marketing messaging.

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Where do market-structure and competition matter most?

KYNMOBI’s competition is less about same-day therapeutic substitution and more about therapy sequencing:

• Competing modalities
  • Alternative gene therapies and disease-modifying options can displace demand through earlier lines of therapy.
• Institutional formularies
  • Treatment centers and health systems often standardize workflows and referral pathways, which can lock in preferential uptake for selected therapies.
• Reimbursement strategy
  • Payers may negotiate across high-cost therapies; formulary access can shift when contract terms change.

Net effect: Market share movements may be abrupt and contract-led, rather than gradual and sales-force driven.

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How does launch-year scaling typically translate into a financial trajectory for one-time gene therapies?

For one-time high-cost therapies, revenue typically follows a staged ramp:

• Phase 1: launch ramp
  • Treated volumes grow as centers finalize operational readiness and payers approve initial cases.
• Phase 2: normalization
  • Revenue stabilizes as approvals, center throughput, and patient funnel efficiency reach maturity.
• Phase 3: plateau or decline
  • Revenue can plateau as the addressable treated pool tightens, or decline if payer policy narrows eligibility.

This pattern is consistent with gene therapy commercialization where the unit economics per patient are high but the throughput is limited.

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What are the financial signposts that matter for KYNMOBI?

Investors and operators typically track five metrics that predict revenue trajectory more reliably than top-line growth alone:

1. Treated patient count
   • Primary driver of gross product revenue for one-time therapies.
2. Net price per treated patient
   • Driven by rebates, patient assistance, chargebacks, and payer-specific negotiated terms.
3. Payer coverage breadth
   • Number of plans with “workable” coverage policies and approval turnaround times.
4. Center network expansion
   • Growth in the number of capable treatment sites and their throughput.
5. Time-to-approval and time-to-treatment
   • Drives realized revenue timing (cash flow schedule and recognition patterns).

Implication for financial trajectory: Even with stable pricing, net revenue can vary materially based on approval cadence and rebates.

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What does historical gene-therapy market behavior imply for KYNMOBI’s near-to-mid term?

Given the structural constraints above, the base case for one-time gene therapy in the commercialization window typically looks like:

• Revenue ramp tied to execution and approvals
  • Growth depends on turning diagnosis into treatment at scale.
• Higher volatility in quarterly outcomes
  • One or two delayed approvals can shift quarter revenue materially.
• Greater sensitivity to payer policy updates
  • Changes in medical policy or coverage criteria can accelerate or slow demand rapidly.

KYNMOBI’s financial trajectory therefore should be read through treated-patient trends, coverage breadth, and timing metrics rather than through broader market growth narratives.

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How do supply and administration economics affect unit economics?

Gene therapies have a different cost stack than chronic drugs:

• Manufacturing and quality control
  • AAV vector manufacturing and QC drive cost-of-goods for each batch and can constrain supply if yields or batch release schedules tighten.
• Clinical administration costs
  • Treatment center costs include pre-treatment evaluation, dosing procedure, and long-tail monitoring.
• Specialized drug handling
  • Cold-chain logistics and handling requirements can add marginal overhead at centers.

Revenue impact channel: Supply limits or administration scheduling can delay treatment, shifting revenue recognition timing and cash conversion.

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What cash-flow and working-capital mechanics should be expected?

High-cost therapies can show working-capital sensitivity because:

• Large invoices occur near dosing
  • Collections depend on payer processing schedules and contract terms.
• Rebates and patient assistance programs move cash-out
  • Net revenue timing is affected by reconciliation cycles.
• Chargebacks and dispute resolution can be lumpy
  • Gene therapy claims complexity can add administrative variance.

Financial trajectory implication: Operating cash flow can lag revenue, especially during the ramp when claims volumes and contract disputes are still settling into operational routines.

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Market outlook scenarios for KYNMOBI (demand-driven)

Scenario A: Coverage broadens and center throughput scales

• Treated-patient count rises across quarters.
• Net price remains stable or improves if contracts are renegotiated.
• Revenue growth sustains through the expansion phase.

Scenario B: Payer coverage narrows to stricter eligibility

• Approvals slow and marginal eligible cases drop out.
• Treated-patient growth decelerates, leading to revenue plateau.
• Net price can decline via higher rebates if payers re-negotiate.

Scenario C: Supply constraints delay dosing

• Treated-patient count is capped by manufacturing release and logistics.
• Revenue timing becomes volatile, with lumped quarters.
• Unit economics can worsen if supply costs rise with batch disruption.

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Key Takeaways

• KYNMOBI’s market dynamics are driven primarily by eligibility funnel, payer authorization governance, and treatment-center throughput rather than by classic mass-market demand drivers.
• Financial trajectory should be evaluated through treated-patient counts, net price realization, payer coverage breadth, and time-to-approval because one-time gene therapies create revenue volatility tied to execution.
• Revenue ramp is likely staged: launch execution lifts treated volume, normalization stabilizes results, and plateau risk rises when payer policies or eligibility boundaries tighten.

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FAQs

1) What determines KYNMOBI’s realized demand more than marketing?

Treated-patient eligibility and payer authorization speed determine how quickly diagnosed patients become dosed patients.

2) Why is quarterly revenue for gene therapies typically volatile?

Revenue tracks dosing events and claim approvals; a small number of delayed approvals can shift quarterly totals.

3) What metrics best predict KYNMOBI’s financial performance?

Treated patient counts, net price per treated patient, coverage breadth across plans, center throughput, and time-to-treatment.

4) How do payer policies influence revenue trajectory?

Coverage criteria can narrow eligibility and reduce marginal approvals, slowing treated-patient growth and causing revenue to plateau.

5) What operational factors can cap growth even with payer coverage?

Manufacturing release timing, center scheduling capacity, and monitoring workflow constraints can limit how many patients can be treated.

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References

[1] FDA. Drug Approval Package (searchable product dossier pages for KYNMOBI/lenadogene nolparvovec). U.S. Food and Drug Administration.

DrugChatter Q&A for KYNMOBI

What are the side effects of Kynmobi?