Nintedanib esylate - Generic Drug Details

What are the generic drug sources for nintedanib esylate and what is the scope of patent protection?

Nintedanib esylate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nintedanib esylate has one hundred and ninety-seven patent family members in fifty-three countries.

There are eight drug master file entries for nintedanib esylate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for nintedanib esylate

International Patents:	197
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	148
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nintedanib esylate
DailyMed Link:	nintedanib esylate at DailyMed

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

Dosage:

CAPSULE;ORAL

^*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.

Generic filers with tentative approvals for NINTEDANIB ESYLATE

Applicant	Application No.	Strength	Dosage Form
		EQ 150MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nintedanib esylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for nintedanib esylate

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for NINTEDANIB ESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OFEV	Capsules	nintedanib esylate	100 mg and 150 mg	205832	4	2018-10-15

US Patents and Regulatory Information for nintedanib esylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes					Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes					Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes					Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No

Expired US Patents for nintedanib esylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014

International Patents for nintedanib esylate

Country	Patent Number	Title	Estimated Expiration
Australia	1023301
Chile	2010001362	Forma de dosificacion farmaceutica para la liberacion inmediata de la sustancia activa 3-z-[1-(4-(n-((4-metil-piperazin-1-il)-metilcarbonil)-n-metil-amino)-anilino)-1-fenil-metileno]-6-metoxicarbonil-2-indolinona-monoetanosulfonato; y su uso para el tratamiento y/o prevencion de enfermedades oncologicas e inmunologicas, entre otras.
Japan	2003511441
Japan	2011522812
Hong Kong	1052505
Egypt	25931	In6-position substituted indolines the preparationthereof and their use as pharmaceutical compositi ons

Supplementary Protection Certificates for nintedanib esylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1224170	PA2015015,C1224170	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170	2015/017	Ireland		PRODUCT NAME: VARGATEF-NINTEDANIB, THE TAUTOMERS AND THE PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1830843	PA2015025	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115
1830843	CA 2015 00036	Denmark		PRODUCT NAME: NINTEDANIB ELLER EN TAUTOMER, BLANDINGERNE DERAF ELLER ET SALT DERAF, SAERLIGT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/979/001-004 20150115
1224170	17/2015	Austria		PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
1830843	122015000052	Germany		PRODUCT NAME: NINTEDANIB ODER EIN TAUTOMER, DIE MISCHUNGEN HIERVON, ODER EIN SALZ HIERVON, INSBESONDERE NINTEDANIB-ESILAT; REGISTRATION NO/DATE: EU/1/14/979/001-004 20150115

Market Dynamics and Financial Trajectory for Nintedanib Esylate

Introduction to Nintedanib Esylate

Nintedanib esylate, marketed under the brand name Ofev, is a potent tyrosine kinase inhibitor used primarily in the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Projections

The nintedanib esylate market has been experiencing significant growth. As of 2023, the market size was valued at USD 50 billion and is projected to reach USD 92.55 billion by 2031, growing at a compound annual growth rate (CAGR) of 8% from 2024 to 2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the nintedanib esylate market:

Rising Incidence of Fibrotic Disorders

The increasing prevalence of idiopathic pulmonary fibrosis (IPF) and other chronic lung diseases, particularly among the aging population, is a major driver. Early and frequent diagnoses, facilitated by growing awareness and improvements in diagnostic methods, have led to higher demand for effective treatments like nintedanib esylate[1][4].

Efficacy and Expanded Indications

Nintedanib esylate's effectiveness in slowing the progression of fibrosis and enhancing patients' quality of life has made it a leading therapeutic option. Its approval for extended indications, such as systemic sclerosis-associated interstitial lung disease (SSc-ILD) and chronic fibrosing interstitial lung diseases, further expands its market potential[1][3][4].

Technological and Scientific Advancements

Continuous research and development efforts to broaden the drug's indications and improve its therapeutic profile contribute to market growth. Technological advancements in medicine enable the creation of more targeted and potent treatments[1].

Government Support and Funding

Encouraging government programs and funding for the study and treatment of rare diseases also drive market expansion. These initiatives help in increasing access to the drug and supporting further research[1].

Market Segmentation

The nintedanib esylate market is segmented based on several criteria:

Type

• Tablets
• Capsules
• Oral Solution
• Injection[1]

Application

• Idiopathic Pulmonary Fibrosis
• Systemic Sclerosis-associated Interstitial Lung Disease
• Chronic Fibrosing Interstitial Lung Diseases[1]

Geographical Regions

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa[1]

Financial Performance

Revenue and Growth Rate

The market is expected to register a CAGR of approximately 9.11% from 2025 to 2032, with the market size projected to grow from USD 2.94 billion in 2024 to USD 5.9 billion by 2032[4].

Historical Sales Data

In 2018, Ofev (nintedanib esylate) generated 1.1 billion euros in sales for IPF, representing a 29% growth. In the first half of 2019, sales grew by 22% to 677 million euros[3].

Market Opportunities

Expanded Applications

Research into broader applications of nintedanib esylate beyond IPF, such as SSc-ILD and other fibrotic diseases, presents significant market opportunities. As clinical evidence supports its effectiveness in these conditions, pharmaceutical companies can capitalize on this expanded usage to drive growth and meet unmet medical needs[4].

Challenges and Resistances

High Cost and Accessibility

One of the notable resistances in the market is the high cost of nintedanib esylate, which can limit accessibility, particularly in emerging markets or among patients without comprehensive insurance coverage. This, coupled with potential side effects associated with long-term use, may impact the overall market expansion[4].

Competitive Landscape

The nintedanib esylate market includes several key players:

• Boehringer Ingelheim
• Roche
• Novartis
• AstraZeneca
• Sanofi
• Amgen
• GlaxoSmithKline
• AbbVie
• Merck & Co.
• Johnson & Johnson
• Bayer
• Bristol-Myers Squibb
• Pfizer
• Eli Lilly and Company[4]

Patent and Regulatory Landscape

Nintedanib esylate, marketed as Ofev, is protected by several patents, with the earliest generic entry expected on December 7, 2029, pending any patent challenges or generic licensing agreements[5].

Clinical and Regulatory Milestones

Ofev was originally approved for IPF in 2014 and later for SSc-ILD in 2019. The drug has undergone extensive clinical trials, and its development milestones include various regulatory approvals and market launches in key regions such as the United States, EU5, and Japan[3].

SWOT Analysis

Strengths

• Efficacy in treating IPF and other fibrotic disorders
• Expanded indications
• Strong market presence and brand recognition

Weaknesses

• High cost and potential accessibility issues
• Side effects associated with long-term use

Opportunities

• Expansion into other fibrotic diseases
• Growing awareness and diagnostic capabilities
• Government support and funding

Threats

• Generic competition post-patent expiration
• Regulatory challenges and changes in healthcare policies[3][4]

Key Takeaways

• The nintedanib esylate market is driven by the rising incidence of fibrotic disorders and its efficacy in treating these conditions.
• The market is expected to grow significantly, with a projected CAGR of 8-9% over the next several years.
• Expanded applications and government support are key opportunities for market growth.
• High cost and potential side effects are significant challenges.
• The competitive landscape includes major pharmaceutical companies, and the patent landscape will influence future market dynamics.

FAQs

1. What is the current market size of nintedanib esylate?

The nintedanib esylate market was valued at USD 50 billion in 2023[1].

2. What is the projected growth rate of the nintedanib esylate market?

The market is expected to grow at a CAGR of approximately 8-9% from 2024 to 2031/2032[1][4].

3. What are the primary applications of nintedanib esylate?

The primary applications include idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and chronic fibrosing interstitial lung diseases[1][3][4].

4. Who are the key players in the nintedanib esylate market?

Key players include Boehringer Ingelheim, Roche, Novartis, AstraZeneca, and several other major pharmaceutical companies[4].

5. When are the patents for nintedanib esylate expected to expire?

The earliest generic entry is expected on December 7, 2029, pending any patent challenges or generic licensing agreements[5].

Sources:

1. MarketResearchIntellect: Nintedanib Esylate Market Size and Projections[1]
2. PMC: Using group based trajectory modeling for assessing medication adherence[2]
3. BusinessWire: Ofev (Nintedanib) Drug Insight and Market Forecast Report 2020-2030[3]
4. OpenPR: Nintedanib Esylate Market Revenue, Opportunity, Forecast[4]
5. DrugPatentWatch: When do the patents on OFEV expire, and when do they go generic?[5]

Last updated: 2024-12-18