Details for Patent: 9,907,756

Which drugs does patent 9,907,756 protect, and when does it expire?

Patent 9,907,756 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 forty-four patent family members in thirty-five countries.

Summary for Patent: 9,907,756

Title:	Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
Abstract:	The present invention relates to a suspension formulation containing the active substance 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate, to a capsule pharmaceutical dosage form containing said suspension formulation, to a process for preparing said suspension formulation, to a process for preparing said capsule comprising said suspension formulation and to the packaging material for the finished capsule.
Inventor(s):	Roman Messerschmid, Rudolf Binder, Thomas Bock, Werner Brox
Assignee:	Boehringer Ingelheim Pharma GmbH and Co KG
Application Number:	US15/204,277
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,907,756
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

United States Patent 9,907,756: Nintedanib Esylate Formulation Claims, Expiration, Orange Book Status, and Generic Risk

U.S. Patent No. 9,907,756 protects lipid-based capsule formulations of nintedanib esylate, the active pharmaceutical ingredient in Ofev. Its central limitation is a lipid suspension containing medium-chain triglycerides, hard fat, and lecithin within specified weight ranges. The patent does not broadly claim nintedanib, nintedanib salts, or every oral formulation. It targets a particular lipid vehicle and capsule presentation.

The patent was issued to Boehringer Ingelheim-related interests and has an estimated patent-term expiration in 2029, subject to the official patent-term calculation and any applicable adjustment. The claims create a formulation barrier for products using the claimed excipient combination, but they leave potential design-around routes based on different lipid systems, excipient concentrations, dosage forms, or non-lipid formulations.

What drug does U.S. Patent 9,907,756 protect?

U.S. Patent 9,907,756 protects formulations of nintedanib esylate, also known as nintedanib ethanesulfonate. Nintedanib is a small-molecule tyrosine kinase inhibitor marketed by Boehringer Ingelheim as Ofev.

The chemical name in the claims corresponds to the ethanesulfonate salt of nintedanib:

Attribute	Description
Active ingredient	Nintedanib esylate
Brand	Ofev
Drug class	Small-molecule tyrosine kinase inhibitor
Main U.S. indications	Idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis-associated interstitial lung disease
FDA dosage forms	100 mg and 150 mg oral capsules
Regulatory pathway	New drug application
Patent type	Formulation and dosage-form patent
Patent number	U.S. 9,907,756
Grant date	March 6, 2018
Patent owner or assignee	Boehringer Ingelheim-related entity

Nintedanib inhibits VEGFR, FGFR, and PDGFR signaling. The patent does not claim those biological activities. It claims how nintedanib esylate is physically formulated and enclosed in a capsule.

What are the core claims of U.S. Patent 9,907,756?

The patent has two principal claim groups.

The first group covers a lipid suspension containing nintedanib esylate, medium-chain triglycerides, hard fat, and lecithin. The second group covers capsules containing that suspension.

Claim	Subject matter	Key limitation
1	Formulation	Nintedanib esylate in a lipid suspension with 1 to 90 wt.% medium-chain triglycerides, 1 to 30 wt.% hard fat, and 0.1 to 10 wt.% lecithin
2	Capsule	Capsule containing the formulation of claim 1
3	Capsule subtype	Soft gelatin capsule
4	Capsule shell	Glycerol as a plasticizer
5	Capsule alternatives	Hard gelatin, HPMC, polyvinyl alcohol, or pullulan capsule, optionally sealed or banded
6	Lipid suspension	Nintedanib esylate, medium-chain triglycerides, hard fat, and lecithin in the same ranges; “consisting essentially of” language
7	Capsule	Capsule containing the suspension of claim 6
8	Capsule subtype	Soft gelatin capsule

Claims 1 and 6 are the commercial center of gravity. Claims 2 through 5, 7, and 8 add packaging and dosage-form restrictions.

How broad are the formulation claims?

Claim 1 is relatively broad within the defined lipid-suspension field. It uses “comprises,” which generally permits additional ingredients unless another limitation excludes them. A formulation may therefore contain other excipients and still fall within claim 1 if it includes the required active ingredient and the three specified excipient categories in the claimed ranges.

The ranges are broad:

Component	Claimed range
Medium-chain triglycerides	1 to 90 wt.%
Hard fat	1 to 30 wt.%
Lecithin	0.1 to 10 wt.%

The claim does not specify:

• A particular medium-chain triglyceride grade
• A specific hard-fat identity
• A specific lecithin source
• A required particle-size distribution
• A defined nintedanib concentration
• A capsule fill weight
• A particular release profile
• A specific manufacturing process
• A particular dosage strength
• A required bioavailability result

Those omissions increase the claim’s potential reach across multiple commercial compositions. They also identify potential validity and design-around issues if the patent’s specification does not adequately support the full breadth of the claimed ranges.

Claim 6 is narrower in linguistic form because it uses “consisting essentially of.” That phrase generally permits components that do not materially alter the basic and novel characteristics of the claimed suspension, while excluding ingredients that materially change those characteristics. The practical boundary depends on the patent specification, prosecution history, and the role of additional excipients.

What formulations are protected by the patent?

A product is at greatest literal-infringement risk when it has all of the following characteristics:

1. Nintedanib esylate as the active pharmaceutical ingredient.
2. A lipid suspension rather than a conventional aqueous or solid formulation.
3. Medium-chain triglycerides within 1 to 90 wt.%.
4. Hard fat within 1 to 30 wt.%.
5. Lecithin within 0.1 to 10 wt.%.
6. A capsule containing that suspension, if a capsule claim is asserted.

The claim language does not require the formulation to use the Ofev trade name, a particular capsule color, or a specific commercial manufacturing process.

A generic manufacturer could face separate analysis for each product strength. If both 100 mg and 150 mg capsules use the same claimed excipient architecture, both may present substantially similar risk. If the generic uses materially different excipient levels or replaces one required component, the literal infringement analysis changes.

When does U.S. Patent 9,907,756 expire?

The patent is expected to expire in 2029 based on its priority and filing history, subject to the official patent-term calculation, patent-term adjustment, and any terminal disclaimer.

Event	Date or status
Earliest reported priority	2008
U.S. grant	March 6, 2018
Expected base term endpoint	2029
Patent-term adjustment	Must be confirmed from the USPTO patent record
Patent-term extension	No extension should be assumed without an applicable FDA regulatory record
Pediatric exclusivity	Separate FDA exclusivity, if granted, would not change the patent expiration date

The 2029 endpoint is commercially important because a formulation patent can remain relevant after earlier compound or basic composition patents expire. Generic entry may therefore require a successful Paragraph IV position against the formulation patent or a product design that avoids the listed claims.

What is the Orange Book status of U.S. Patent 9,907,756?

U.S. Patent 9,907,756 has been associated with the Ofev patent estate and is relevant to FDA-listed patent protection for nintedanib capsules. The precise Orange Book listing, use code, and current active status should be read from the FDA’s latest Approved Drug Products with Therapeutic Equivalence Evaluations database and the product-specific patent listing.

Orange Book relevance depends on whether the patent is listed against the applicable Ofev strengths and whether its claims correspond to the approved drug product. A formulation patent generally supports a certification requirement for an ANDA applicant when it is properly listed against the reference product.

Orange Book issue	Business implication
Listed formulation patent	ANDA applicant may need a Paragraph I, II, III, or IV certification
Paragraph IV certification	Can trigger notice and patent litigation
Paragraph III certification	Delays approval until patent expiration
Unlisted or delisted patent	May reduce the statutory ANDA litigation pathway, but does not eliminate ordinary infringement exposure
Claim covering approved capsule formulation	Higher risk for an Ofev-like generic
Claim requiring a non-approved feature	Potential basis for arguing the patent does not cover the marketed product

The Orange Book listing should not be treated as a final determination of validity, enforceability, or infringement. FDA listing and judicial claim construction are separate issues.

How does the patent interact with the broader nintedanib patent estate?

Nintedanib protection is likely to include several layers:

Patent layer	Protected subject matter	Strategic role
Compound patents	Nintedanib and related chemical structures	Core exclusivity
Salt patents	Esylate or other pharmaceutically acceptable salts	Salt-specific protection
Formulation patents	Lipid suspension and capsule architecture	Product-specific barrier
Method-of-use patents	Treatment of pulmonary fibrosis and related diseases	Indication-specific protection
Process patents	Manufacture, crystallization, purification, or encapsulation	Supply-chain barrier
Regulatory exclusivity	New chemical entity, supplement, or orphan-related exclusivity	FDA approval timing

U.S. Patent 9,907,756 is not a compound patent. Its commercial value depends on the extent to which Ofev and prospective generic products use the claimed lipid suspension.

The patent can remain relevant even if a generic avoids the basic compound patent. A non-infringing generic would need to avoid the claimed combination or prevail in a validity or claim-construction dispute.

What generic entry risks exist for Ofev?

The highest-risk generic scenario is an ANDA product that copies the Ofev dosage form and uses the same or overlapping excipient ranges. That approach may simplify formulation development but increases Paragraph IV exposure.

Scenario 1: Same lipid suspension

A generic using nintedanib esylate, medium-chain triglycerides, hard fat, and lecithin within the claimed ranges would face the strongest infringement case. A Paragraph IV certification could lead to patent litigation and a 30-month FDA approval stay if the statutory requirements are met.

Scenario 2: Same capsule, different lipid system

A generic could use a different lipid vehicle, such as a formulation without hard fat or lecithin. The product could avoid literal infringement of claims 1 and 6, although the full patent family and doctrine-of-equivalents issues would require review.

Scenario 3: Solid dosage form

A tablet, dry powder, or non-lipid capsule could avoid the principal formulation claims if it does not contain the claimed lipid suspension. Bioequivalence and absorption may make this route technically more difficult because nintedanib is formulated for oral exposure and tolerability.

Scenario 4: Outside-range composition

A product with one component outside the claimed range may avoid literal infringement. This strategy carries formulation-development risk because small changes may affect dispersion, stability, dissolution, tolerability, and bioequivalence.

Generic strategy	Formulation risk	Patent risk	Regulatory risk
Copy Ofev lipid capsule	Low to moderate	High	Moderate
Remove hard fat	Moderate	Lower for literal infringement	Moderate to high
Remove lecithin	Moderate	Lower for literal infringement	Moderate to high
Use non-lipid capsule	High	Lower	High
Use outside-range excipient levels	Moderate	Potentially lower	Moderate
Pursue Paragraph IV	No formulation change required	Litigation exposure	Approval delay possible

Are biosimilars relevant to nintedanib?

No. Nintedanib is a chemically synthesized small molecule, not a biologic. A competing product would proceed through the abbreviated new drug application pathway rather than the biosimilar pathway under the Biologics Price Competition and Innovation Act.

The principal competitive risk is therefore generic substitution, not biosimilar interchangeability. FDA approval would generally require demonstration of pharmaceutical equivalence and bioequivalence to the reference product, subject to the applicable ANDA requirements.

What method-of-use patents affect nintedanib?

Nintedanib’s commercial patent estate includes method-of-use protection for pulmonary and fibrotic diseases. Those patents may cover treatment of:

• Idiopathic pulmonary fibrosis
• Systemic sclerosis-associated interstitial lung disease
• Chronic fibrosing interstitial lung disease with a progressive phenotype
• Other pulmonary or fibrotic conditions, depending on the claim language

Method-of-use patents can support a Section viii “skinny label” strategy if the ANDA applicant omits patented indications and the remaining label is legally and commercially viable. The formulation claims in U.S. Patent 9,907,756 are different. They are not limited to a particular disease indication and may be asserted based on the composition of the product itself.

Which companies are challenging Ofev patent protection?

Publicly available FDA and court records should be reviewed for current ANDA notices, Paragraph IV litigation, and settlement agreements involving specific nintedanib applicants. The existence of an ANDA filing, a Paragraph IV certification, or a district-court complaint can change quickly and should not be inferred solely from the patent grant.

No biosimilar challenger is relevant because Ofev is a small-molecule drug. The commercially relevant challengers are generic manufacturers with the capability to develop an oral nintedanib product and establish bioequivalence.

How strong is the patent estate for U.S. Patent 9,907,756?

The patent has meaningful commercial strength but narrower legal scope than a compound patent.

Strengths

• It covers the lipid architecture associated with the marketed capsule.
• The excipient ranges are broad.
• Claim 1 uses open “comprises” language.
• Claims cover both the suspension and capsule formats.
• Dependent claims provide alternative capsule-shell configurations.
• A generic that copies the reference product may have difficulty avoiding the claims.

Vulnerabilities

• The claims require all three excipient categories.
• A product outside one or more claimed ranges may avoid literal infringement.
• The patent does not claim every nintedanib formulation.
• Broad ranges may face written-description or enablement scrutiny if the specification does not support the entire scope.
• Prior-art lipid suspensions and capsule formulations may support an obviousness challenge.
• “Consisting essentially of” in claim 6 can create disputes over permitted additional ingredients.
• The patent’s enforceability depends on prosecution-history disclosures, inventorship, priority, and maintenance-fee status.

The strongest enforcement position is against a product that closely replicates the Ofev formulation. The weakest position is against a non-lipid dosage form or a formulation that omits one required excipient category.

What is the revenue exposure from loss of formulation exclusivity?

Ofev is a major Boehringer Ingelheim product with annual sales measured in the billions of euros. Boehringer reported Ofev sales of approximately €3.4 billion in 2023, making generic entry economically significant even if the product retains use in multiple fibrotic diseases.

Revenue erosion would depend on:

• The expiration of compound and formulation patents
• The number of approved generic competitors
• The extent of automatic substitution
• Generic pricing discounts
• The ability of Boehringer to maintain differentiation
• The timing and scope of Paragraph IV settlements
• Continued growth in progressive fibrosing lung-disease indications

A formulation patent alone may not prevent all generic entry. It can delay or increase the cost of entry when the reference formulation is difficult to replicate without using the patented excipient system.

What licensing or settlement issues are relevant?

The patent is associated with the Boehringer Ingelheim nintedanib franchise. No licensing arrangement should be assumed merely because a third party manufactures, distributes, or seeks approval for a nintedanib product.

Potential settlement structures in this category include:

• An agreed generic launch date before patent expiration
• A license limited to specific strengths
• A formulation redesign covenant
• A no-admission patent settlement
• A supply or authorized-generic arrangement
• A settlement covering multiple nintedanib patents

A definitive assessment requires the specific settlement agreement, court docket, or FDA approval record. Patent ownership, commercialization rights, and litigation rights may differ among Boehringer Ingelheim affiliates.

Key Takeaways

• U.S. Patent 9,907,756 is a formulation patent for nintedanib esylate, not a basic compound patent.
• The core claims require a lipid suspension containing medium-chain triglycerides, hard fat, and lecithin within defined weight ranges.
• Claims 2 through 5 and 7 through 8 extend protection to capsules, including soft gelatin, hard gelatin, HPMC, polyvinyl alcohol, and pullulan capsules.
• The expected patent-term endpoint is in 2029, subject to official patent-term adjustment and related records.
• The strongest generic risk arises from an Ofev-like capsule using the same three-component lipid system.
• A non-lipid formulation or a composition outside at least one required range may provide a design-around route.
• Nintedanib is a small molecule, so generic ANDA litigation, not biosimilar litigation, is the relevant competitive framework.
• The patent’s commercial strength is substantial for copied formulations but materially weaker against alternative dosage forms and excipient systems.
• Ofev’s multibillion-euro annual sales make the timing and structure of generic entry financially significant.

FAQs

Does U.S. Patent 9,907,756 cover nintedanib itself?

No. It covers specified lipid suspensions and capsules containing nintedanib esylate. Separate compound or salt patents may provide broader protection.

Can a generic use nintedanib without using the patented formulation?

Potentially. A generic may avoid this patent by using a formulation that does not contain the required combination of medium-chain triglycerides, hard fat, and lecithin within the claimed ranges. Other patents may still apply.

Does a softgel automatically infringe U.S. Patent 9,907,756?

No. The softgel must also contain a formulation meeting the applicable lipid-suspension limitations. Capsule shape alone is insufficient.

Is a formulation outside the claimed weight ranges automatically safe?

No. It may avoid literal infringement of the specific range limitation, but other claims, related patents, or a doctrine-of-equivalents theory may remain relevant.

Does the patent block all non-Ofev nintedanib products until 2029?

No. The patent is limited to the claimed formulation and capsule structures. It does not automatically block every nintedanib product, although the broader patent family may create additional barriers.

References

1. Boehringer Ingelheim International GmbH. (2018). Lipid suspension of a kinase inhibitor (U.S. Patent No. 9,907,756). United States Patent and Trademark Office.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

3. U.S. Food and Drug Administration. (2024). Ofev prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc.

4. Boehringer Ingelheim. (2024). Annual report 2023. Boehringer Ingelheim International GmbH.

5. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term calculation resources. USPTO.

Drugs Protected by US Patent 9,907,756

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	AB	RX	Yes	No					Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	AB	RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 9,907,756

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	08157748	Jun 6, 2008

International Family Members for US Patent 9,907,756

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	072059
Australia	2009254548
Australia	2015227503
Brazil	PI0913434