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-four 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:	94
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	134
Patent Applications:	4,149
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
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/004786 Inbrija 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
Israel	153281
Singapore	10201706465X	HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE
Denmark	1381416
Poland	374794
Japan	4897198
Singapore	11201503543P	HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE

Supplementary Protection Certificates for INBRIJA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	11/2023	Austria		PRODUCT NAME: KOMBINATION VON FOSLEVODOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON UND FOSCARBIDOPA ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON; REGISTRATION NO/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	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
1613296	92782	Luxembourg		PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224

Market Dynamics and Financial Trajectory for INBRIJA

Introduction

INBRIJA, a levodopa inhalation powder developed by Acorda Therapeutics, is a significant player in the treatment of Parkinson’s disease, particularly for managing OFF periods. Here, we delve into the market dynamics and financial trajectory of INBRIJA, highlighting key milestones, challenges, and future projections.

Market Position and Growth

INBRIJA currently enjoys a dominant market share within the on-demand treatment class for Parkinson’s disease, holding a 67% market share. This is largely due to its preference among healthcare professionals and patients over other on-demand treatments like apomorphine-based products[4].

U.S. Market

In the U.S., INBRIJA has shown consistent growth. For the quarter ended September 30, 2023, U.S. net revenue from INBRIJA was $8.1 million, a 4% increase compared to the same quarter in 2022. For the full year 2022, INBRIJA U.S. net revenue was $28 million, meeting the company's guidance targets[2].

International Expansion

Acorda Therapeutics has been actively expanding INBRIJA into international markets. The drug was launched in Germany in mid-2022 and in Spain in early 2023. For the third quarter of 2023, ex-U.S. INBRIJA net revenue was $1.4 million, primarily from sales in Spain. Discussions are ongoing for commercialization in additional EU markets and Asia, with expectations of increased ex-U.S. revenue in 2023 and 2024[2][4].

Financial Performance

Revenue Trends

• 2022: INBRIJA global net revenue was $30.9 million, with $28 million from U.S. sales and $2.9 million from ex-U.S. sales. This represented a slight increase from the $29.6 million in U.S. sales in 2021[1].
• 2023: For the third quarter, worldwide INBRIJA net revenue was $9.5 million, a 7% increase. The full-year 2023 guidance for INBRIJA U.S. net revenue has been revised to $34-$38 million, reflecting continued growth but at a slower pace than initially projected[2][5].

Cost Management and Efficiency

Acorda has made significant strides in reducing operating expenses. The renegotiation of manufacturing agreements with Catalent and the arbitration award related to AMPYRA have contributed to lower costs. For 2023, the adjusted operating expense (OPEX) guidance has been revised to $93-$98 million, down from the initial range of $93-$103 million[1][5].

Key Milestones and Initiatives

Launches and Partnerships

• The successful launches in Germany and Spain have been crucial for expanding INBRIJA's global footprint. Partnerships, such as the one with Esteve, have facilitated these launches and are expected to drive future growth[1][3].
• Acorda is also planning to launch Biopas in Latin America in early 2024, which is expected to add to the revenue stream[1].

Marketing and Sales Strategies

• Acorda has implemented several high-potential initiatives to grow the INBRIJA business, including new brand campaigns for physicians and patients, expanding the use of an E-prescribing platform, and introducing a cash-pay option to improve patient access. The sales team has adopted a hyper-targeted call strategy to enhance sales performance[4].

Challenges and Opportunities

Market Competition

Despite its market share, INBRIJA faces competition from other on-demand treatments. However, healthcare professionals' preference for INBRIJA due to its safety and efficacy profile continues to be a strong advantage[4].

Patient Access

Less than 2% of the 380,000 people with Parkinson’s who experience OFF periods are actively on any on-demand treatment. This presents a significant opportunity for INBRIJA to expand its market by increasing awareness and access to the treatment[4].

Financial Guidance and Projections

2023 Financial Guidance

• INBRIJA U.S. net revenue is expected to be $34-$38 million.
• Adjusted OPEX is guided to be $93-$98 million.
• The ending cash balance is expected to be $39-$44 million.
• Despite the revised guidance, INBRIJA is expected to continue its growth trajectory, albeit at a slower pace than initially anticipated[2][5].

Long-Term Outlook

Acorda Therapeutics aims to be cash-flow positive in the future, with INBRIJA playing a central role in achieving this goal. The company's long-term plan includes continued expansion into new markets and maintaining fiscal discipline to ensure sustainable growth[4].

Key Takeaways

• Market Dominance: INBRIJA holds a 67% market share in the on-demand treatment class for Parkinson’s disease.
• Revenue Growth: INBRIJA has shown consistent revenue growth in the U.S. and is expanding into international markets.
• Cost Efficiency: Acorda has successfully reduced operating expenses through renegotiated agreements and cost-saving initiatives.
• Future Projections: INBRIJA is expected to continue growing, with a focus on expanding into new markets and improving patient access.

FAQs

1. What is INBRIJA, and how does it treat Parkinson’s disease? INBRIJA is a levodopa inhalation powder used to treat OFF periods in patients with Parkinson’s disease. It provides on-demand relief by delivering levodopa directly to the lungs.

2. What is the current market share of INBRIJA in the on-demand treatment class? INBRIJA currently holds a 67% market share within the on-demand treatment class for Parkinson’s disease[4].

3. Which international markets has INBRIJA been launched in? INBRIJA has been launched in Germany and Spain, with plans for further expansion into Latin America and other EU and Asian markets[1][3].

4. How has Acorda Therapeutics managed to reduce operating expenses for INBRIJA? Acorda has reduced operating expenses through the renegotiation of manufacturing agreements with Catalent, arbitration awards, and other cost-saving initiatives[1][5].

5. What are the financial guidance and projections for INBRIJA in 2023? For 2023, INBRIJA U.S. net revenue is expected to be $34-$38 million, with adjusted OPEX guided to be $93-$98 million and an ending cash balance of $39-$44 million[2][5].

Sources

1. Acorda Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results - Acorda Therapeutics Investor News[1].
2. Acorda Therapeutics Reports Third Quarter 2023 Financial Results - Acorda Therapeutics Investor News[2].
3. Acorda Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results - Acorda Therapeutics Investor News[3].
4. Acorda Therapeutics Provides Long-Term Business Plan and Financial Guidance - BioSpace[4].
5. Acorda Therapeutics Reports Second Quarter 2023 Financial Results - Acorda Therapeutics Earnings Release[5].

Last updated: 2024-12-17