ofev Drug Patent Profile

When do Ofev patents expire, and when can generic versions of Ofev launch?

Ofev is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-seven patent family members in fifty-three countries.

The generic ingredient in OFEV is nintedanib esylate. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Ofev

Ofev was eligible for patent challenges on October 15, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 7, 2029. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (nintedanib esylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for ofev

International Patents:	197
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Patent Applications:	209
Drug Prices:	Drug price information for ofev
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ofev
What excipients (inactive ingredients) are in ofev?	ofev excipients list
DailyMed Link:	ofev at DailyMed

See drug prices for ofev

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

Constraining patent/regulatory exclusivity:

9,907,756*PED

NDA:

205832

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.

Pharmacology for ofev

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for OFEV

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 ofev

ofev is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,907,756.

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
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	6,762,180*PED				Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	10,154,990*PED				Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	9,907,756*PED				Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	10,105,323*PED				Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes	6,762,180*PED				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	9,907,756*PED				Y

Expired US Patents for ofev

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014	7,119,093
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	7,989,474
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	7,119,093
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014	7,989,474

International Patents for ofev

When does loss-of-exclusivity occur for ofev?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 ofev around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	0014735
China	1671660	3-z-[1-(4-(n-((4-methyl-piperazin-1-yl)-methylcarbonyl)-n-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate and the use thereof as a pharmaceutical composi
Denmark	1224170
Montenegro	01493
Montenegro	00353	3-Z-[1-(4-(N-((4-METIL-PIPERAZIN-1-IL)-METILKARBONIL)-N-METIL-AMINO)-ANILINO)-1-FENIL-METILEN]-6-METOKSIKARBONIL-2-INDOLINON-MONOETANSULFONAT I NJEGOVA PRIMENA U FARMACEUTSKOJ KOMPOZICIJI (3-Z-[1-(4-(N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-ANILINO)-1-PHENYL-METHYLENE]-6-METHOXYCARBONYL-2-INDOLINONE-MONOETHANESULPHONATE AND THE USE THEREOF AS A PHARMACEUTICAL COMPOSITION)
South Korea	20070090038
Yugoslavia	26602

Supplementary Protection Certificates for ofev

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1224170	15C0024	France		PRODUCT NAME: NINTEDANIB,SES TAUTOMERES ET SES SELS,EN PARTICULIER LES SELS PHYSIOLOGIQUEMENT ACCEPTABLES DE NINTEDANIB ET PLUS PARTICULIEREMENT L'ESILATE; REGISTRATION NO/DATE: EU/1/14/954 20141125
1224170	300725	Netherlands		PRODUCT NAME: NINTEDANIB, DE TAUTOMEREN DAARVAN EN DE ZOUTEN DAARVAN, IN HET BIJZONDER NINTEDANIB EN FYSIOLOGISCH AANVAARDBARE ZOUTEN DAARVAN, MET NAME NINEDANIBESILAAT; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141125
1224170	428	Finland
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	PA2015015	Lithuania		PRODUCT NAME: NINTEDANIBUM; 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

Market Dynamics and Financial Trajectory for Ofev (Nintedanib)

Overview of Ofev

Ofev, also known as nintedanib, is a tyrosine kinase inhibitor developed by Boehringer Ingelheim. It is primarily used to treat idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases, including those associated with systemic sclerosis (SSc-ILD)[1][3][4].

Approval and Indications

Ofev was first approved by the FDA in October 2014 for the treatment of IPF. In 2019, its indications were extended to include the treatment of interstitial lung disease caused by systemic sclerosis (SSc-ILD)[1][4].

Market Performance

Sales Growth

Ofev has demonstrated significant sales growth over the years. In 2018, its sales grew by almost 29% to reach 1.1 billion euros, primarily driven by its use in treating IPF. By the first half of 2019, sales had grown an additional 22% to 677 million euros. More recently, in 2023, Ofev saw a 12.8% increase in sales, reaching €3.5 billion[1][5].

Market Size and Forecast

The global market for IPF treatments, led by Ofev and Esbriet (pirfenidone), is projected to grow substantially. By 2031, the global IPF market is estimated to reach $11.7 billion, growing at a CAGR of 7.3%[3].

Geographic Market Distribution

The US market is the largest contributor to Ofev's sales, accounting for more than 85% of the total sales in the forecast period. This is due to the high prevalence of IPF and increasing drug prices in the US. In contrast, sales in Japan and the EU5 (Germany, France, Italy, Spain, and the UK) are expected to remain relatively stable due to lower prevalence and treatment costs[3].

Competitive Landscape

Market Competitors

Ofev faces competition from other drugs used to treat IPF and related conditions, such as Esbriet (pirfenidone), Azasan (azathioprine), Rayos (prednisone), and Prograf (tacrolimus). However, Ofev and Esbriet are the only two therapies clinically proven to significantly slow disease progression in IPF patients, giving them a strong market position[1][2][3].

Emerging Therapies

The market is expected to see the launch of late-stage emerging therapies, which could impact Ofev's market share. However, until generic competitors enter the market, Ofev and Esbriet are likely to maintain their dominance[1][3].

Financial and Insurance Considerations

Cost of Ofev

The cost of Ofev can vary significantly based on factors such as treatment plan, insurance coverage, and the pharmacy used. Since Ofev is only available as a brand-name drug and has no generic version until 2029, it remains expensive. The cost can be mitigated through savings programs, mail-order pharmacies, and obtaining a 90-day supply if approved by the insurance company[2][4].

Insurance Coverage

Ofev may be covered by Medicare Part D, but the extent of coverage and out-of-pocket costs vary depending on the specific plan. Patients without insurance or with limited coverage may need to explore other financial assistance options or online pharmacy alternatives[2][4].

Regulatory and Development Milestones

Patent Details

Ofev's patent allows Boehringer Ingelheim to maintain exclusivity until 2029, after which generic versions can be developed. This exclusivity period has contributed to Ofev's strong market position and revenue growth[1][2].

Clinical Trials and Safety

Ofev has undergone extensive clinical trials to establish its safety and efficacy. The drug has shown significant results in slowing disease progression in IPF patients, which has been a key factor in its market success[1].

Boehringer Ingelheim's Financial Performance

Overall Sales

Boehringer Ingelheim's human pharma sales, driven significantly by Ofev and Jardiance (empagliflozin), reached €20.8 billion in 2023. This represents a 10.3% increase from the previous year, with Ofev contributing €3.5 billion to this total[5].

Research and Development Investments

The company has also increased its research and development investments, reaching €5.8 billion in 2023, which accounts for 22.5% of their net sales. This commitment to R&D is crucial for maintaining innovation and market leadership[5].

Key Takeaways

• Strong Sales Growth: Ofev has shown consistent sales growth, driven by its effectiveness in treating IPF and SSc-ILD.
• Market Dominance: Ofev, along with Esbriet, dominates the IPF treatment market due to their proven efficacy.
• Geographic Market: The US market is the largest contributor to Ofev's sales, with significant growth expected in this region.
• Competitive Landscape: Emerging therapies and generic competitors will impact the market, but Ofev's current exclusivity maintains its market position.
• Financial Considerations: The cost of Ofev is high due to its brand-name status, but savings programs and mail-order pharmacies can help reduce costs.
• Regulatory and Development: Ofev's patent exclusivity and strong clinical trial results support its market success.

FAQs

Q: What conditions is Ofev used to treat?

Ofev is used to treat idiopathic pulmonary fibrosis (IPF) and interstitial lung disease associated with systemic sclerosis (SSc-ILD)[1][3][4].

Q: Why is Ofev so expensive?

Ofev is expensive due to the extensive research and testing required to ensure its safety and efficacy, as well as its brand-name status without a generic version available until 2029[2][4].

Q: Is Ofev covered by Medicare?

Ofev may be covered by Medicare Part D, but the extent of coverage and out-of-pocket costs vary depending on the specific plan[4].

Q: How can I reduce the cost of Ofev?

You can reduce the cost of Ofev by using savings programs, mail-order pharmacies, and obtaining a 90-day supply if approved by your insurance company[2][4].

Q: What is the projected market size for IPF treatments by 2031?

The global market for IPF treatments is estimated to reach $11.7 billion by 2031, growing at a CAGR of 7.3%[3].

Sources

1. Research and Markets: Ofev (Nintedanib) - Drug Insight and Market Forecast - 2030.
2. Healthline: Ofev and Cost: What You Need to Know.
3. iHealthcareAnalyst: Global Idiopathic Pulmonary Fibrosis Market $11.7 Billion by 2031.
4. MedicalNewsToday: Ofev cost 2024: Coupons and more.
5. Pharmaceutical Technology: Jardiance and Ofev propel Boehringer's human pharma sales.