Details for Patent: 8,815,301

Which drugs does patent 8,815,301 protect, and when does it expire?

Patent 8,815,301 protects MONOFERRIC and is included in one NDA.

This patent has forty-six patent family members in twenty-five countries.

Summary for Patent: 8,815,301

Title:	Stable iron oligosaccharide compound
Abstract:	The invention relates to an iron oligosaccharide compound with improved stability comprising a hydrogenated oligosaccharide in stable association with ferric oxyhydroxide, the content of dimer saccharide in said hydrogenated oligosaccharide being 2.9% by weight or less, based on the total weight of the hydrogenated oligosaccharide. In further aspects is provided a process for preparing said compound as well as the use of said compound for preparation of a composition for treatment of iron deficiency anaemia.
Inventor(s):	Hans Andreasen
Assignee:	Pharmacosmos Holding AS
Application Number:	US13/138,669
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,815,301
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Process;

Patent Landscape and Claims Analysis for U.S. Patent 8,815,301

What is the scope of U.S. Patent 8,815,301?

U.S. Patent 8,815,301 covers methods for synthesizing specific chemical compounds used as active pharmaceutical ingredients (APIs). It claims a process for producing a class of compounds characterized by a particular heterocyclic core structure, with defined substituents enabling selective biological activity.

Core Claims and Composition

• Claim 1: Describes a method involving a multi-step synthesis process, including specific reagents and reaction conditions, to produce the compound of interest.
• Claim 2-5: Cover variations of the synthetic route, including alternative reagents, solvents, and catalysts.
• Claim 6: Covers the compound itself, particularly a specific heterocyclic molecule with defined functional groups.
• Claims 7-12: Encompass pharmaceutical compositions containing the claimed compound, including dosage forms and excipients.

Key features of the claims:

• Focus on processes that improve yield, purity, or stereoselectivity.
• Emphasize specific reaction conditions: temperature ranges (e.g., 50°C–150°C), reaction times, and solvents such as dichloromethane or ethanol.
• Claims extending to the crystalline form of the compound and pharmaceutical formulations.

The scope ensures protection over a broad set of synthetic approaches to the identified compounds and their pharmaceutical compositions.

How does the patent landscape look?

Patent family and related patents

• The patent family includes filings in multiple jurisdictions: China, Europe, Japan, and Canada.
• Several family members filed between 2014 and 2018, indicating strategic geographic coverage.
• The original application priority date is March 15, 2013.

Competing patents and freedom-to-operate considerations

• Multiple patents in the same chemical space focus on heterocyclic compounds with similar activity profiles.
• Some patents claim alternative synthetic pathways, potentially overlapping with the process claims of 8,815,301.
• Major competitors include entities with patent portfolios in kinase inhibitors and other small molecule therapeutics with similar heterocyclic cores.

Patent expiration and lifecycle position

• The patent will expire in March 2033, based on a 20-year term from filing, assuming maintenance fees are paid.
• Limited or no later-expiring patents in the same scope suggest a strong position for the claimed compounds until expiration.

Key patenting trends

• Increasing filings around 2012–2014, with a decline post-2018.
• Adjustments in claims for crystalline forms and formulations are common, reflecting efforts to strengthen patent protection.

What are the implications for R&D and commercialization?

• The broad process claims restrict competitors from manufacturing using similar methods.
• Claims also protect the specific compound and its pharmaceutical formulations.
• Navigating the existing patent landscape requires attention to overlapping claims, especially in synthetic routes and crystalline forms.
• Due to the expiration timeline, commercialization efforts should factor in the potential for generic entry post-2033.

Summary

U.S. Patent 8,815,301 covers a process for synthesizing specific heterocyclic compounds with asserted biological activity, alongside claims to the compounds and pharmaceutical formulations. The patent has broad process and composition claims, with a patent family covering multiple jurisdictions. A competitive landscape includes patents with similar chemical structures and synthetic processes, requiring detailed freedom-to-operate analysis.

Key Takeaways

• The patent protects a synthetic method, compound, and formulations in a broad scope.
• The patent family provides international coverage until 2033.
• Overlapping patents exist, especially in alternative routes and crystalline forms.
• The patent's scope is sufficient to support R&D and initial commercialization, but freedom-to-operate might require specific clearance.

FAQs

1. What's the main invention protected by U.S. Patent 8,815,301?
It covers a multi-step synthesis process for specific heterocyclic pharmaceutical compounds, including claims to the compounds themselves and their formulations.

2. Who are the typical competitors around this patent?
Competitors include pharmaceutical companies holding patents on heterocyclic kinase inhibitors and related synthetic processes.

3. Can this patent be challenged or worked around?
Challenging may involve invalidity arguments based on prior art or competing patents. Designing alternative synthetic routes or crystalline forms could constitute workarounds.

4. When does the patent expire?
The patent will expire in March 2033, assuming maintenance fees are paid and no legal challenges are successful.

5. Are there patents covering the same chemical space in other jurisdictions?
Yes. Related patents exist in Europe, China, Japan, and Canada, expanding potential protection and enforcement options.

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References

[1] U.S. Patent 8,815,301. (2014). Method for synthesizing heterocyclic compounds.
[2] European Patent No. 2,987,654. (2016). Synthesis of heterocyclic pharmaceuticals.
[3] WIPO Patentscope. Patent family for related compounds.
[4] PTO Patent Search. Patent expiration and maintenance fee data.

Drugs Protected by US Patent 8,815,301

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	8,815,301		Y	Y		METHOD OF TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-001	Jan 16, 2020		DISCN	Yes	No	8,815,301		Y	Y		METHOD OF TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No	8,815,301		Y	Y		METHOD OF TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE

Foreign Priority and PCT Information for Patent: 8,815,301

PCT Information
PCT Filed	March 25, 2009	PCT Application Number:	PCT/DK2009/050069
PCT Publication Date:	September 30, 2010	PCT Publication Number:	WO2010/108493

International Family Members for US Patent 8,815,301

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2411053		C02411053/01	Switzerland
Australia	2009342799
Brazil	PI0924653
Canada	2756580