Details for Patent: 10,154,990

Which drugs does patent 10,154,990 protect, and when does it expire?

Patent 10,154,990 protects OFEV and is included in one NDA.

Protection for OFEV has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-five patent family members in thirty-three countries.

Summary for Patent: 10,154,990

Title:	Medicaments for the treatment or prevention of fibrotic diseases
Abstract:	The present invention relates to the use of indolinones of general formula ##STR00001## substituted in the 6 position, wherein R.sub.1 to R.sub.5 and X are defined as in claim 1, the isomers and the salts thereof, particularly the physiologically acceptable salts thereof, as a medicament for the prevention or treatment of specific fibrotic diseases.
Inventor(s):	Park; John Edward (Warthausen, DE), Roth; Gerald Juergen (Biberach, DE), Heckel; Armin (Biberach, DE), Chaudhary; Nveed (Southampton, GB), Brandl; Trixi (Allschwil, CH), Dahmann; Georg (Warthausen-Birkenhard, DE), Grauert; Matthias (Biberach an der Riss, DE)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:	14/982,179
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,154,990
Patent Claim Types: see list of patent claims	Use; Composition;

Understanding the Scope and Claims of United States Patent 10,154,990: A Detailed Analysis

Introduction

The United States Patent 10,154,990, assigned to Boehringer Ingelheim International GmbH, is a crucial patent related to the drug Nintedanib, marketed under the brand name Ofev. This patent is significant due to its implications for the treatment of various fibrotic diseases and the upcoming changes in the patent landscape.

Patent Overview

Patent Number and Expiration Date

The patent number is 10,154,990, and it is scheduled to expire on December 20, 2025[2][5].

Inventors and Assignees

The inventors listed for this patent include John Edward Park, Gerald Juergen Roth, Armin Heckel, Nveed Chaudhary, Trixi Brandl, Georg Dahmann, and Matthias Grauert. The assignee is Boehringer Ingelheim International GmbH[5].

Scope of the Patent

Indications and Use

This patent pertains to the use of indolinones, specifically Nintedanib, for the treatment or prevention of fibrotic diseases. Nintedanib is used in the treatment of idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and other fibrotic conditions[4][5].

Composition of Matter

The patent covers the composition of matter for Nintedanib, which is a small molecule tyrosine kinase inhibitor. The specific chemical structure and formulation of Nintedanib are protected under this patent[4].

Claims of the Patent

Method of Use Claims

The patent includes method of use claims that specify how Nintedanib is to be used in the treatment of fibrotic diseases. These claims are critical as they define the therapeutic applications of the drug[4].

Formulation Claims

In addition to the method of use, the patent also covers specific formulations of Nintedanib. This includes the immediate release profile of the pharmaceutical dosage form, which ensures the drug is delivered effectively to the patient[5].

Patent Landscape

Current Patent Status

As of the current date, the patent 10,154,990 is active and will expire on December 20, 2025. Other related patents for Nintedanib have different expiration dates, with some already expired and others extending into the late 2020s and early 2030s[2][5].

Patent Filings Trend

There has been a significant surge in patent filings related to Nintedanib since 2022, with over 100 patents filed. This trend indicates a high level of interest from various pharmaceutical companies, including big pharma entities like Hoffmann La Roche and Gilead, as well as generic manufacturers and universities[1].

Jurisdictional Filing Trends

The majority of patents related to Nintedanib have been filed in the United States and China, reflecting the market interests of companies in these regions. Other countries like Canada, Australia, and Japan have fewer patent counts, highlighting the differing market priorities[1].

Impact of Patent Expiration

Generic Competitors

The expiration of the key patent for Nintedanib in 2025 will enable generic manufacturers to offer cost-effective alternatives. This is likely to increase competition in the market and reduce the cost of treatment for patients. Companies like Accord Healthcare Inc. have already filed ANDAs (Abbreviated New Drug Applications) with paragraph IV certifications, indicating their intent to market generic versions of Nintedanib[2][5].

Market Dynamics

The entry of generic competitors will likely alter the market dynamics for Nintedanib. Boehringer Ingelheim will face increased competition, which could impact their market share and revenue. However, this also opens opportunities for collaborations and licensing agreements between the original patent holder and generic manufacturers[1].

Strategic Implications

ANDA Filings

Strategic ANDA filings are critical for generic manufacturers to secure an early mover advantage. Companies that file ANDAs early can gain a 180-day exclusivity period, which can be a significant competitive advantage in the generic market[1][2].

University and Institute Involvement

Universities and research institutes, such as the University of California, are actively involved in patent filings related to Nintedanib. This suggests potential collaborations between these entities and generic companies, which could accelerate the development and approval of generic versions[1].

Key Takeaways

• Patent Expiration: The patent 10,154,990 expires on December 20, 2025, opening the market for generic versions of Nintedanib.
• Scope and Claims: The patent covers the composition of matter, method of use, and specific formulations of Nintedanib for treating fibrotic diseases.
• Market Impact: The expiration will increase competition, reduce treatment costs, and potentially alter market dynamics.
• Strategic Filings: Early ANDA filings and collaborations with universities and research institutes are crucial for securing market advantages.

FAQs

What is the primary indication for Nintedanib covered under the patent 10,154,990?

The primary indication is the treatment or prevention of fibrotic diseases, including idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD)[4].

Who are the inventors listed for the patent 10,154,990?

The inventors include John Edward Park, Gerald Juergen Roth, Armin Heckel, Nveed Chaudhary, Trixi Brandl, Georg Dahmann, and Matthias Grauert[5].

What is the significance of the patent expiration date for Nintedanib?

The expiration date allows generic manufacturers to produce and market generic versions of Nintedanib, potentially reducing treatment costs and increasing competition in the market[1][2].

Which companies are involved in filing patents related to Nintedanib?

Apart from Boehringer Ingelheim, companies like Sunshine Lake Pharma, Jiangsu Hengrui Medi, Aiviva Biopharma, Hoffmann La Roche, and Gilead are involved in filing patents related to Nintedanib[1].

How will the entry of generic competitors affect the market for Nintedanib?

The entry of generic competitors will increase competition, potentially reducing Boehringer Ingelheim's market share and revenue, but also providing more affordable treatment options for patients[1][2].

Sources

1. GreyB, "The Ofev Patent Thicket: Patents expiring in 2026," GreyB Blog.
2. U.S. Food & Drug Administration, "Nintedanib Capsules," FDA.
3. Hoover Institution, "Patent Claims and Patent Scope," Hoover Institution.
4. Google Patents, "US10154990B2 - Medicaments for the treatment or prevention of fibrotic diseases," Google Patents.
5. Drugs.com, "Generic Ofev Availability," Drugs.com.

Drugs Protected by US Patent 10,154,990

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

Foreign Priority and PCT Information for Patent: 10,154,990

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	04030770	Dec 24, 2004

International Family Members for US Patent 10,154,990

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1830843		C300747	Netherlands
European Patent Office	1830843		122015000052	Germany
European Patent Office	1830843		CA 2015 00036	Denmark