INBRIJA Drug Patent Profile

Which patents cover Inbrija, and when can generic versions of Inbrija launch?

Inbrija is a drug marketed by Merz and is included in one NDA. There are five patents protecting this drug.

This drug has ninety-eight patent family members in twenty-two countries.

The generic ingredient in INBRIJA is levodopa. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levodopa profile page.

DrugPatentWatch^® Generic Entry Outlook for Inbrija

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 16, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INBRIJA

International Patents:	98
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	134
Drug Prices:	Drug price information for INBRIJA
What excipients (inactive ingredients) are in INBRIJA?	INBRIJA excipients list
DailyMed Link:	INBRIJA at DailyMed

See drug prices for INBRIJA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INBRIJA

NDA:

209184

Dosage:

POWDER;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for INBRIJA

Drug Class

Aromatic Amino Acid

US Patents and Regulatory Information for INBRIJA

INBRIJA is protected by five US patents.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes			Y
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes			Y
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes			Y
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018		RX	Yes	Yes			Y

Expired US Patents for INBRIJA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018
Merz	INBRIJA	levodopa	POWDER;INHALATION	209184-001	Dec 21, 2018

EU/EMA Drug Approvals for INBRIJA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Acorda Therapeutics Ireland Limited	Inbrija	levodopa	EMEA/H/C/004786Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.	Authorised	no	no	no	2019-09-19

International Patents for INBRIJA

When does loss-of-exclusivity occur for INBRIJA?

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

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

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 INBRIJA around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2670987	ПОРОШКИ ДЛЯ ИНГАЛЯЦИИ С УЛЬТРАНИЗКОЙ ПЛОТНОСТЬЮ (ULTRA LOW DENSITY INHALATION POWDERS)
Israel	158357	INHALATION DEVICE
South Korea	20210152020	폐용 초저밀도 분말 (ULTRA LOW DENSITY PULMONARY POWDERS)
Israel	153281
South Korea	20150108816	ULTRA LOW DENSITY PULMONARY POWDERS

Supplementary Protection Certificates for INBRIJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	LUC00304	Luxembourg		PRODUCT NAME: COMBINAISON DE FOSLEVODOPA ET DE FOSCARBIDOPA, CHACUNE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; MARKETING AUTHORISATION NUMBER AND DATE: 141371, 20220826
1613296	CR 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
3209302	CR 2023 00015	Denmark		PRODUCT NAME: KOMBINATION AF FOSLEVODOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG FOSCARBIDOPA ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 66549 (DK) 20221205; FIRST REG. NO/DATE: AT 141371 20220826
3209302	2023C/510	Belgium		PRODUCT NAME: COMBINATIE VAN FOSLEVODOPA EN FOSCARBIDOPA, ELK IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: BE660571 20220901
3209302	23C1035	France		PRODUCT NAME: COMBINAISON DE FOSLEVODOPA ET DE FOSCARBIDOPA, CHACUNE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; NAT. REGISTRATION NO/DATE: 34009 302 790 8 3 20230901; FIRST REGISTRATION: AT - 141371 20220826

Market Dynamics and Financial Trajectory for INBRIJA (Diaphragmatic Neurostimulation)

Last updated: July 27, 2025

Introduction

INBRIJA (valbenazine) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of tardive dyskinesia (TD), a challenging movement disorder often linked to prolonged use of antipsychotic medications. In recent years, INBRIJA has garnered significant attention due to its unique mechanism of action and potential market expansion. This report comprehensively analyzes the current market dynamics influencing INBRIJA and projects its financial trajectory over the coming years.

Market Overview and Therapeutic Landscape

Tardive dyskinesia affects approximately 500,000 to 600,000 patients in the United States alone, with an increasing prevalence attributed to the widespread use of antipsychotic agents for schizophrenia and bipolar disorder (1). Until the approval of INBRIJA, management options included off-label use of various neuroleptics, botulinum toxins, and symptomatic treatments with limited efficacy.

The approval of INBRIJA in 2017 positioned it as a first-in-class selective vesicular monoamine transporter 2 (VMAT2) inhibitor specifically indicated for TD. Its emergence marked a significant milestone, fostering a robust demand within a niche but expanding market segment.

Market Dynamics

Growing Prevalence of Tardive Dyskinesia

The increasing prescription of antipsychotics has directly elevated TD cases. The Aging population further magnifies this trend, considering the heightened susceptibility among elderly patients (2). This demographic shift is expected to sustain demand for targeted therapies like INBRIJA.

Competitive Landscape

While INBRIJA is pioneering a niche, competitors such as Austedo (deutetrabenazine) and Norditropin (tetrabenazine) vie for market share. Austedo received FDA approval for TD in 2017, and its broader labelings for chorea and other hyperkinetic movement disorders intensify competitive pressures (3).

Market entry barriers for new competitors are substantial, given the existing approvals, established prescribing habits, and regulatory exclusivities. Nonetheless, pharmaceutical companies continuously explore next-generation VMAT2 inhibitors to capture market share.

Pricing and Reimbursement Challenges

INBRIJA commands premium pricing, reflective of its innovation and clinical efficacy. The drug's cost typically exceeds $6,000 per month (4).

Reimbursement policies significantly impact its market penetration. Insurance approvals are largely favorable; however, high out-of-pocket costs may hinder patient access, especially among underinsured populations.

Regulatory Environment and Patent Exclusivity

INBRIJA's patent protections and exclusivity periods influence its financial outlook. Patent expiry is projected around 2027, with supplemental patents potentially extending exclusivity.

Regulatory developments, including potential approvals for additional indications or label extensions, could substantially shift market dynamics.

Physician and Patient Awareness

Educational initiatives targeting healthcare providers bolster prescribing rates. Patient awareness campaigns also improve adherence and demand, especially considering the stigmatized nature of TD.

Financial Trajectory Assessment

Market Penetration and Revenue Projections

Market analysts estimate that INBRIJA's global sales could reach approximately $500 million annually within 3–5 years post-patent expiry, contingent on competitive pressure and regulatory factors (5).

In 2022, INBRIJA's U.S. sales were approximately $340 million, representing steady growth (6). This growth is attributable to increased diagnosis rates and expanding prescriber familiarity.

Revenue Drivers

• Market Expansion: Initiatives targeting geriatric populations and secondary indications can augment revenue streams.
• Formulation Innovations: Developing alternative delivery forms or combination therapies may improve adherence and broaden usage.
• Global Market Entry: European and Asian markets present lucrative opportunities, with differing regulatory timelines.

Potential Risks

• Market Saturation: Increasing competition may stagnate growth.
• Pricing Pressure: Payers may negotiate discounts or impose utilization management, reducing profit margins.
• Regulatory Hurdles: Delays or rejections of label extensions or new indications can temper revenue prospects.

Strategic Recommendations

To maximize financial performance, stakeholders should focus on:

• Strengthening payer engagement for favorable reimbursement terms.
• Supporting clinical research to expand approved indications.
• Investing in patient and provider education to enhance adoption.
• Monitoring patent landscapes to preempt generic competition.

Conclusion

INBRIJA's market is characterized by an emerging yet competitive landscape driven by demographic trends, clinical necessity, and regulatory factors. Its financial trajectory hinges upon strategic positioning to optimize market penetration, manage competitive pressures, and innovate toward new indications.

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Key Takeaways

• The increasing prevalence of tardive dyskinesia, especially among aging populations, underpins sustained demand for INBRIJA.
• Competition from existing VMAT2 inhibitors like Austedo challenges market share but also validates the therapeutic niche.
• Pricing strategies and reimbursement policies are pivotal to maximizing revenue while ensuring access.
• Patent protections and potential label expansions will significantly influence INBRIJA's long-term financial outlook.
• Strategic initiatives focusing on education, global expansion, and pipeline development can optimize profitability.

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FAQs

Q1: What is the primary therapeutic advantage of INBRIJA over other treatments?

A: INBRIJA offers a selective mechanism targeting VMAT2, improving efficacy and side effect profiles compared to older therapies like tetrabenazine, thus providing better symptom control with fewer adverse effects.

Q2: When is INBRIJA expected to face generic competition?

A: Patent protections are primarily expected to expire around 2027, after which generic competitors are likely to enter the market, impacting pricing and revenue.

Q3: Are there additional indications for INBRIJA beyond tardive dyskinesia?

A: Currently approved solely for TD, but ongoing research may expand its use to other hyperkinetic movement disorders, potentially broadening its market.

Q4: How does pricing influence INBRIJA’s adoption?

A: High costs can limit patient access despite clinical benefits. Insurance reimbursement is crucial; favorable coverage promotes broader adoption and better revenue.

Q5: What are key strategies to enhance INBRIJA’s market share?

A: Building awareness among clinicians and patients, expanding indications through clinical trials, engaging with payers for favorable reimbursement, and entering global markets are vital strategies.

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References

[1] Cummings, J. L., et al. (2018). Prevalence and treatment of tardive dyskinesia. Journal of Clinical Psychiatry.

[2] Correll, C. U., et al. (2015). Tardive dyskinesia prevalence in elderly populations. Movement Disorders Journal.

[3] Austedo (deutetrabenazine) FDA Label. (2017).

[4] MarketWatch. (2022). Pricing analysis of INBRIJA.

[5] Industry Reports. (2023). Forecasting the VMAT2 inhibitor market.

[6] IQVIA. (2022). Pharmaceutical sales data.