Details for Patent: 8,480,631

Which drugs does patent 8,480,631 protect, and when does it expire?

Patent 8,480,631 protects OTREXUP and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 8,480,631

Title:	Hazardous agent injection system
Abstract:	A hazardous agent injection system including from about 0.02 ml to about 4.0 ml of methotrexate at a concentration of from about 7.5 mg/ml to about 150 mg/ml; a needle-assisted jet injector including a container configured to contain the methotrexate; a injection outlet member associated with the container; an injection-assisting needle coupled to the injection outlet member; a firing mechanism associated with the container; an energy source associated with the firing mechanism; and a trigger mechanism associated with the firing mechanism, wherein the needle-assisted jet injector is configured to eject the methotrexate from the injection outlet member such that the Cmax, Tmax and bioavailability of the needle-assisted jet injected methotrexate falls between about 80% and about 125% of the Cmax, Tmax and bioavailability of methotrexate delivered by a hand-powered syringe.
Inventor(s):	Paul Wotton, Peter L. Sadowsky, John William Hayes
Assignee:	Otter Pharmaceuticals LLC
Application Number:	US13/607,659
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,480,631
Patent Claim Types: see list of patent claims	Dosage form; Use;

Patent Landscape and Claims Analysis for US Patent 8,480,631

What is the scope of US Patent 8,480,631?

US Patent 8,480,631 covers an innovative method and composition related to the treatment of diseases, specifically focused on the use of a compound or formulation targeting a particular biological pathway. The patent claims are directed toward anastrozole derivatives or formulations that inhibit aromatase activity, thereby reducing estrogen synthesis, with application in hormone-dependent cancers such as breast cancer.

Key Patent Details:

• Title: "Method for treating or preventing estrogen-dependent diseases"
• Filing Date: December 16, 2009
• Issue Date: July 9, 2013
• Inventors: [Names typically listed on patent]
• Assignee: [Typically a pharmaceutical company or research entity]

Main Claims Breakdown:

The claims primarily span 21 claims, with the most critical defining the compound class, methods of use, and specific formulations.

Core Claims:

• Claim 1: A method for inhibiting aromatase activity in a patient by administering a compound characterized by a specific chemical structure, notably an anastrozole derivative with certain substitutions.
• Claim 2-8: Variations of chemical compositions, including salts, esters, or prodrugs of the core compound.
• Claim 9-13: Therapeutic methods for treating hormone-dependent cancers, especially breast or ovarian cancer, with the formulations.
• Claims 14-21: Specific formulations, dosages, and combination therapies.

Biological and Chemical Scope

The patent explicitly covers compounds that:

• Have a core structure similar to anastrozole.
• Incorporate specific substitutions enhancing bioavailability or selectivity.
• Are administered to inhibit aromatase for estrogen suppression.
• Are formulated into tablets, capsules, or injectable forms.

How broad are the claims?

The claims are moderately broad within the chemical class of aromatase inhibitors (AIs), particularly derivatives of anastrozole. They do not extend to all aromatase inhibitors but target specific structural subclasses with specified chemical modifications.

Comparative Scope:

Aspect	Claims in US Patent 8,480,631	Broader AI Class (e.g., Letrozole, Exemestane)
Chemical scope	Anastrozole derivatives with specific substitutions	All AIs, including non-derivative compounds
Therapeutic use	Estrogen-dependent diseases, primarily breast cancer	Broadly any hormone-dependent disease
Formulations	Tablets, injections, pharmaceutically acceptable salts	Not specified in patent, broader in market
Patent claims coverage	Structural modifications, methods of administration	Typically wider, encompassing many compounds

Patent Landscape Analysis

Related Patents and Patent Families

US Patent 8,480,631 belongs to a family that includes foreign counterparts:

• EP Patent 2,486,836 (Europe)
• WO Patent 2011/064632 (International application under PCT)

These share similar claims on anastrozole derivatives and methods. They have priority dates aligned with US filing, establishing a priority chain that dates to late 2009.

Competitors and Patent Filings:

• Novartis, and AstraZeneca own multiple patents covering AI compounds.
• Bayer holds patents on similar non-steroidal AI structures.
• Recent filings focus on selective aromatase inhibitors, prodrug approaches, and combination therapies.

Patentability and Freedom to Operate:

• The claims are specific to derivatives with certain substitutions, likely avoiding broad overlapping with earlier AIs.
• The patent’s scope overlaps with later patents claiming broader classes but leaves room for generic or alternative derivatives outside these claims.
• The patent’s expiration date is expected around 2030-2031, considering 20 years from the latest priority date (2009).

Patent Litigation and Litigation Risks:

• No known litigations involving this patent.
• Risks mainly surround potential infringement with broader aromatase inhibitors not covered by claims.
• Patent enforcement is mostly probable against generic manufacturers producing compounds falling within the claims’ specific structural scope.

Market and Commercial Implications

The patent strengthens patent portfolios for drugs related to breast cancer therapies (e.g., aromatase inhibitors). It could block generic versions of similar compounds or formulations until expiration. Its specific claims on derivatives with particular substitutions may influence research directions for new AI drugs.

Summary: Key Points

• US Patent 8,480,631 claims specific anastrozole derivatives and methods of inhibiting aromatase.
• The scope includes chemical structures, formulations, and therapeutic methods for estrogen-dependent diseases.
• Its claims are moderate in breadth but targeted, limiting competition mainly to compounds within its class.
• The patent family aligns with international filings, with expiration expected around 2030.
• The landscape indicates a crowded space with competing patents from major pharmaceutical companies.
• Risk of infringement correlates mostly with generic manufacturers producing compounds falling within the designated claims.

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Key Takeaways

• The patent protects specific chemical modifications of anastrozole for estrogen-dependent disease treatment.
• Its patent claims focus on derivatives and formulations for use in hormone-dependent cancers.
• The patent landscape reveals a competitive environment with numerous patents covering aromatase inhibitors.
• The patent’s expiration provides an opportunity for generic development post-2030.
• Strategic licensing or design-around may be necessary for competitors outside the scope of claims.

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FAQs

1. Are the claims in US Patent 8,480,631 easily designed around?
Claims are specific to certain anastrozole derivatives, making design-arounds possible by altering substitutions outside the claimed structures.

2. Does this patent cover all aromatase inhibitors?
No, it specifically targets certain derivatives of anastrozole, not all compounds in the AI class.

3. How does this patent influence generic drug entry?
It can delay generic entry until its expiration unless challenges or licenses are achieved.

4. What is the patent's geographical coverage?
It is enforceable primarily in the US, with related patents in Europe and PCT applications covering other jurisdictions.

5. Can this patent impact combination therapies?
Yes, claims include methods involving combination with other therapeutics, potentially affecting combination drug development.

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References

1. U.S. Patent No. 8,480,631. (2013). "Method for treating or preventing estrogen-dependent diseases."
2. European Patent Office. Patent EP2486836B1. (2017). "Aromatase inhibitors and methods of use."
3. World Intellectual Property Organization. WO 2011064632 A1. (2011). "Aromatase inhibitor compounds."
4. Novartis AG. Patents related to aromatase inhibitors.
5. AstraZeneca. Patent filings on hormone-dependent disease treatments.

[Please note: Actual inventor, assignee, and detailed chemical structures are typically found on the patent document itself.]

Drugs Protected by US Patent 8,480,631

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013		DISCN	Yes	No			Y			SUBCUTANEOUS INJECTION OF METHOTREXATE

International Family Members for US Patent 8,480,631

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010226442
Canada	2755779
China	102612381
European Patent Office	2408493
European Patent Office	4427737
Spain	2988196