With an average life expectancy of 3-5 years after diagnosis, Pulmonary fibrosis highlights an urgent need for innovative therapeutic interventions. That’s where medications like Ofev have emerged as a transformative solution.
Ofev is the trade name for Nintedanib by Boehringer Ingelheim. It is a Tyrosine Kinase Inhibitor (TKI) or anti-fibrotic agent used to treat non-small cell lung cancer (NSCLC) and lung diseases like idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung disease (CFILD), and systemic sclerosis-associated interstitial lung disease.
The drug was first approved in 2014 by the FDA (Ofev®) and Europe (Vergatef®), followed by Japan, Australia and Korea.
Here is the timeline for which different countries approved Ofev for different diseases:
How important is Ofev to Boehringer Ingelheim?
Boehringer Ingelheim’s leading product, Ofev®, continuously dominates the pharmaceutical market in treating lung disease (pulmonary fibrosis).
Nintedanib reduces pulmonary fibrosis mortality by 55% and improves overall survival compared to no anti-fibrotic drugs, making it highly effective for treating pulmonary fibrosis and other lung diseases.
Furthermore, another factor contributing to Boehringer’s top performance is the sales of Ofev®, driven by its active molecule patent. However, its molecule patent expires in 2026, allowing generic manufacturers to introduce their versions.
Like every drug company, Boehringer also filed multiple patents around the drug, forming a patent thicket.
Here’s how it looks:
| Indications | Cancer | Lung Disease (Pulmonary Fibrosis/PFILD) | Systemic Scleroderma | Muscular Dystrophy |
| Composition of Matter | US6762180B1 Expires on Apr 01, 2026 | |||
| Indication/ Method of Use | – | EP1530466B1 Expired on Aug 11, 2023 | US10154990B2 Expires on Jul 08, 2029 | US20180280385A1 Under Application stage |
| Dosage Regimen | EP2994125B1 Expires on May 08, 2034 US20120157472A1 Under Application stage | EP2994125B1 Expires on May 08, 2034 US20120157472A1 Under Application stage | – | – |
| Formulation | US9907756B2 Expires in Dec 07, 2029 || US10105323B2 Expires in Dec 04, 2029 || US11813266B2 Expires in Oct 22, 2038 || EP3551187B1 Expires in Dec 06, 2037 || US20240058264A1 | US20130289014A1 | EP2647375A1 | EP3246029A1 | US20190160054A1 Under Application stage | |||
| Other | US7119093B2 (Salt Form) Expired on Feb 21, 2024 EP2900261A1 Under Application stage | |||
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Patent Filing Trend for Ofev
Patent filings for Nintedanib started increasing in 2010, with a gradual rise in rates. This growth became notable from 2017 onwards, and since 2022, there has been a significant surge, with over 100 patents filed.
Top Assignees for Ofev
Apart from Boehringer, companies involved in filing patents for Nintedanib are Sunshine Lake Pharma, Jiangsu Hengrui Medi, Aiviva Biopharma, Hoffmann La Roche, and Gilead.
The involvement of big pharma companies in patent filing for Nintedanib shows their interest in this drug. It can open an opportunity for them after the expiry of its molecule patent.
Filing Trend Based on Jurisdiction
The data presented below indicates that the majority of patents have been filed in the US and China, reflecting the specific market interests of companies. More than 300 patents have been filed for the US, while over 100 patents have been filed for China. However, countries like Canada, Australia, and Japan have notably fewer patent counts, underscoring the differing market interests of companies.
Generic Competitors
Apart from the originator, several other entities, including universities and institutes, are currently involved in patent filing, as indicated in the data below. Most notably, RGT University of California has filed the majority of patents. This suggests active participation of universities in this domain, potentially leading to collaborations with generic companies in the near future.
Entry of Generic Version of Ofev®: A Prediction
The expiration of a key patent for Nintedanib will enable generic manufacturers to offer cost-effective alternatives for consumers. However, it’s crucial to highlight that formulation and method of use patents for Nintedanib remain in effect, with the earliest expiration set for 2029.
Additionally, while applications for generic versions can be submitted to regulatory bodies, the launch of these products into the market is restricted due to the active formulation and method of use patents. Therefore, in the meantime, it is advisable to explore the activities of other active patents.
That’s where our patent monitoring tool, Elixir, can help!
Elixir helps you stay vigilant and monitor activities related to the patents, giving you a headstart in the generic market.
With proper research and careful threat analysis, the extensive task of creating generic versions can transform into a fruitful opportunity.
Get in touch to see Elixir in action.
Authored By – Shadab Riyaz, Life Sciences
Edited By – Ridhima Mahajan, Marketing
Also Read – Understanding the Farxiga®/Forxiga® Patent Thicket: What’s Changing in 2025
