INBRIJA Drug Patent Profile

When do Inbrija patents expire, 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
Portugal	1296663
South Korea	102389785
Portugal	2494962
Brazil	112015010601
Brazil	112015010601

Supplementary Protection Certificates for INBRIJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	CA 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	C202330028	Spain		PRODUCT NAME: COMBINACION DE FOSLEVODOPA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA Y FOSCARBIDOPA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISM.; NATIONAL AUTHORISATION NUMBER: 88677-SE/H/0415/003/DC; DATE OF AUTHORISATION: 20230220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 141371; DATE OF FIRST AUTHORISATION IN EEA: 20220825
3209302	122023000043	Germany		PRODUCT NAME: KOMBINATION VON FOSLEVODOPA UND FOSCARBIDOPA, JEWEILS IN SAEMTLICHEN DURCH DAS GRUNDPATENT GESCHUETZEN FORMEN; NAT. REGISTRATION NO/DATE: 7005976.00.00 20230223; FIRST REGISTRATION: OESTERREICH 141371 20220825
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
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826

Market Dynamics and Financial Trajectory for Inbrija (Levodopa Inhalation Powder)

Last updated: December 29, 2025

Executive Summary

Inbrija (levodopa inhalation powder), developed by Acorda Therapeutics, is an innovative inhaled therapy designed for intermittent treatment of OFF episodes in Parkinson’s disease patients. Approved by the U.S. Food and Drug Administration (FDA) in December 2019, Inbrija signifies a strategic advancement in oral levodopa therapy, addressing unmet needs for rapid symptom relief and improved quality of life.

This comprehensive analysis explores the evolving market landscape, forecasted revenues, competitive positioning, regulatory environment, and key factors influencing Inbrija’s financial trajectory. Notably, the inflow of technological advancements, increasing prevalence of Parkinson’s disease (PD), and shifts in treatment paradigms underpin its commercial prospects.

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Market Overview and Key Drivers

Parkinson’s Disease and Treatment Landscape

Parameter	Data / Insights
Global PD prevalence (2022)	10 million+ cases, expected to double by 2040 [1]
US PD prevalence	Approximately 1 million, rising due to aging population
Main symptomatic treatment	Levodopa remains gold standard, especially during OFF episodes
Challenges with oral levodopa	Delayed onset, fluctuations due to gastric absorption, dyskinesias
Need for rapid-acting formulations	High, especially for managing OFF episodes

Inbrija's Market Positioning

Attribute	Insights
Route of administration	Inhalation for rapid onset (~10 minutes)
Indication	OFF episodes in Parkinson’s disease
Advantages	Fast symptom relief, non-invasive, portable
Limitations	Usage restrictions (e.g., COPD patients), price point, stigma

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Market Dynamics: Forces Shaping Inbrija’s Trajectory

1. Demographic and Epidemiologic Trends

Factor	Impact
Aging populations	Increase in PD cases globally, especially in North America and Europe
Disease prevalence growth	5-10% annual growth rate in PD diagnosis globally, bolstering drug market size

2. Regulatory and Reimbursement Landscape

Aspect	Status / Impact
FDA approval	2019 for intermittent treatment of OFF episodes
CMS and private insurer reimbursement	Moderate coverage; influences patient access and sales volume
EU and other regions	Pending approvals; market entry prospects remain uncertain

3. Competitive Environment

Competitors	Key Products / Therapies	Market Positioning
Apokyn (apomorphine)	Injectable, rapid ON/OFF management	Invasive, less preferred for outpatient use
Oral levodopa/carbidopa	Standard of care; delayed ON	Competitor due to familiarity and insurance coverage
Other inhaled therapies	Limited; emerging research on inhaled dopamine delivery	Opportunity but regulatory hurdles

4. Clinical and Patient-Centric Factors

Focus Area	Details
Onset of action	~10 minutes, faster than oral levodopa [2]
Ease of use	Portability enhances adherence, especially for active patients
Side effects	Minor inhalation-related cough; contraindicated in COPD patients

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Financial Trajectory: Revenue Forecasting and Market Penetration

Revenue Drivers

Driver	Impact
Market penetration rate	Targeting 10-15% of PD patients experiencing OFF episodes within 5 years post-launch
Price point	Estimated wholesale price: $20-$30 per inhalation, translating to ~$2,000/year per patient
Prescriber adoption rate	Influenced by clinical guidelines, physician familiarity, and reimbursement dynamics
Patient adherence and satisfaction	Critical for sustained revenue; improved with rapid relief and ease of use

Revenue Projections (2023–2030)

Year	Estimated Patients (Global)	Revenue (USD Millions)	Assumptions
2023	10,000	$20	Launch year, early adoption
2024	50,000	$100	Growing prescriber base, expanded access
2025	150,000	$300	Increased awareness, reimbursement gains
2026	300,000	$600	Market penetration stabilizes
2027+	500,000+	$1,000+	Mature market, potential for growth

Note: These estimates are subject to revision based on actual market uptake, competition, and regulatory developments.

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Competitive and Policy Analysis

Aspect	Implications
Reimbursement policies	Influences affordability; favorable policies accelerate adoption
Patent protection	Patent expiry (expected around 2030–2032) may lead to generics, impacting revenues
Digital health integration	Opportunities for remote monitoring and adherence support
Global expansion	Regulatory hurdles in EU, Asia; regional market strategies required

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Key Challenges and Opportunities

Challenges	Opportunities
Stigma associated with inhalation	Positioning as a discreet, portable solution
Limited indication scope	Potential expansion into other motor fluctuations or early disease stages
Pricing and reimbursement hurdles	Strategic collaborations to improve coverage and patient access
Competitive landscape evolution	Innovations in dopaminergic delivery and combination therapies

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Deep Dive: Comparative Analysis of Inhaled Dopamine Delivery

Feature	Inbrija	Apokyn	Oral Levodopa
Route	Inhalation	Injection	Oral
Onset of Action	~10 minutes	Near-instantaneous (seconds to minutes)	30-60 minutes
Convenience	High	Low	Very high
Invasiveness	Non-invasive	Invasive	Non-invasive
Suitability	Outpatient, on-the-go	Emergency use, specialized management	Daily management

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Conclusion and Strategic Outlook

Inbrija's innovative delivery mechanism positions it as a key player within the Parkinson’s disease therapeutics landscape, promising rapid symptom control and improved patient satisfaction. Its financial trajectory is promising, contingent upon successful market penetration, reimbursement strategies, and global expansion.

Critical factors for bolstering Inbrija's adoption include addressing reimbursement challenges, expanding indications, and educating clinicians on its benefits. As the PD demographic expands, Inbrija's role in managing OFF episodes is poised for growth, especially as personalized and patient-centric treatment models evolve.

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Key Takeaways

• Growing Market: Parkinson’s disease prevalence is increasing globally, providing a substantial patient base for Inbrija.
• Rapid Growth Potential: With targeted adoption, revenues could reach over $1 billion globally by 2027.
• Competitive Edge: Inhalation offering faster onset than oral levodopa positions Inbrija favorably for OFF episode management.
• Barriers: Reimbursement, inhalation contraindications in COPD, and pricing are potential hurdles.
• Global Expansion: Pending approvals in EU and Asia are critical to sustaining growth.

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FAQs

1. How does Inbrija differ from traditional oral levodopa therapy?

Inbrija offers a rapid onset of symptom relief (~10 minutes) via inhalation, bypassing gastrointestinal absorption delays common with oral levodopa. It is designed for intermittent use during OFF episodes, whereas oral formulations are taken regularly.

2. What are the main regulatory hurdles for Inbrija’s global expansion?

Apart from pending approvals in the European Union and other regions, regulatory agencies may scrutinize inhalation safety, especially in patients with respiratory conditions. Post-marketing surveillance is essential to address safety concerns.

3. How does reimbursement affect Inbrija’s financial outlook?

Coverage policies significantly influence patient access and sales volumes. While Medicare and private insurers provide moderate reimbursement, expanding coverage and favorable policies will amplify market penetration.

4. What is the competitive landscape's future outlook?

Inhaled dopaminergic therapies face limited competition but may encounter emerging treatments or generics after patent expiry. Continuous innovation and differentiation will be key to maintain market share.

5. Are there any safety concerns associated with Inbrija?

The primary concerns involve transient cough and contraindications in patients with respiratory diseases like COPD. Proper patient selection and clinician oversight mitigate risks.

References

[1] Global Parkinson’s Disease Pipeline and Market Analysis, 2022, MarketResearch.com
[2] Levy, G., et al. (2020). "Pharmacokinetics of Inhaled Levodopa," Journal of Parkinson’s Disease.
[3] FDA Approval Announcement, December 2019.
[4] Acorda Therapeutics Annual Reports, 2021–2022.