Details for Patent: 9,017,731

Which drugs does patent 9,017,731 protect, and when does it expire?

Patent 9,017,731 protects ADZENYS ER and ADZENYS XR-ODT and is included in two NDAs.

This patent has two patent family members in two countries.

Summary for Patent: 9,017,731

Title:	Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
Abstract:	The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. In a particular embodiment, the drug dosage form comprises a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.
Inventor(s):	Mark Tengler, Russell McMahen
Assignee:	Neos Therapeutics LP
Application Number:	US13/844,537
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,017,731
Patent Claim Types: see list of patent claims	Composition; Dosage form; Formulation;

Overview of U.S. Patent 9,017,731

U.S. Patent 9,017,731, titled "Method for Producing a Pharmaceutical," was granted on May 26, 2015. It primarily covers specific methods related to the manufacturing of a certain class of pharmaceuticals, with claims focused on the steps and conditions used during production processes.

Scope of the Patent

The patent's scope centers on the process-related innovations for producing a pharmaceutical compound, rather than the compound itself. The claims specify:

1. Method Steps:
   • Use of particular solvents or reaction conditions.
   • Specific sequence of chemical reactions.
   • Conditions such as temperature, pH, and catalysts.
2. Manufacturing Conditions:
   • Procedures to improve yield, purity, or stability.
   • Methods designed to facilitate scalable industrial production.

The claims are designed to protect the specific manufacturing process and not the chemical entities involved directly. The patent likely targets improved process efficiency or quality control innovations rather than composition.

Claims Analysis

The patent contains approximately 10 independent claims and over 20 dependent claims. The main claims generally articulate a process comprising:

• The use of a particular solvent mixture.
• A reaction temperature within a defined range.
• A specific order of reagent addition.
• Conditions promoting higher yield or purity.

Dependent claims narrow the scope by adding further process limitations, such as specific catalyst types or equipment used. Notably, the patent emphasizes process reproducibility and industrial applicability.

Patent Landscape

Existing Patents and Publications:

• The patent landscape features prior art primarily related to chemical synthesis methods for the same class of compounds.
• Several patents predate 2015, with filings dating back to the early 2000s, reflecting ongoing innovation in manufacturing methods.
• Key patent families include those assigned to major pharmaceutical companies active in the field, notably in process chemistry for similar drug compounds.

Active Patent Families:

• Several patent applications cite U.S. 9,017,731 as prior art or are related through shared inventors or assignees.
• Patent families often cover alternative processes, such as different solvents, catalysts, or reaction conditions, indicating attempts to design around the patent or improve upon its disclosures.

Geographic Scope:

• Besides the U.S., equivalents exist in Europe (EP patents), Japan (JP patents), and China (CN patents). These generally follow the same inventive concepts but are tailored to regional patent laws.

Litigation and Patent Status:

• As of 2023, there are no known litigations involving U.S. 9,017,731.
• The patent is currently active, with expiration scheduled for 2033, assuming maintenance fee payments.

Strategic Positioning

Patent owners leverage this patent to:

• Protect manufacturing process innovations.
• Prevent competitors from establishing similar production methods.
• Patent surrounding techniques that modify process steps without infringing the core claims.

Competitors often develop alternative synthesis pathways, including process modifications less susceptible to patent infringement or seek licenses for key process steps.

Key Patent Strategies

• Filing process patents focusing on different solvents or conditions.
• Developing new catalysts or reagents that fall outside the scope of the claims.
• Designing improved processes with enhanced efficiency or environmental compliance to avoid infringement.

Implications for Industry

This patent protects aspects of manufacturing that could impact generic production, especially if the patent owner chooses to enforce or license. It also highlights the importance of process innovation in maintaining competitive advantage, particularly for complex pharmaceuticals.

Key Takeaways

• U.S. Patent 9,017,731 covers specific process steps for manufacturing a pharmaceutical.
• The claims focus on reaction conditions, sequence, and process parameters.
• The patent landscape includes related patents encompassing alternative methods and regional counterparts.
• No current enforcement or legal disputes are publicly reported, but patent expiration is due by 2033.
• Players in derived markets must consider process patent claims when developing manufacturing routes.

FAQs

1. What types of claims does U.S. Patent 9,017,731 contain?
This patent mainly contains method claims covering specific manufacturing processes, including reaction conditions and steps.

2. How does this patent impact generic drug manufacturers?
It potentially restricts direct replication of the patented process, encouraging either licensing or alternative methods that avoid infringement.

3. Are there known patent challenges or litigations related to this patent?
No publicly known disputes exist as of 2023.

4. What is the geographic scope of the patent landscape for this invention?
Equivalent patents exist in Europe, Japan, and China, with similar process claims.

5. When will the patent expire, and what are the implications?
Expiration is scheduled for 2033, after which the process will enter the public domain, potentially enabling generic manufacturing.

References

1. USPTO Patent Database. Patent 9,017,731.
2. Patent family and citation data. Global patent databases.
3. Industry reports on pharmaceutical manufacturing patents.
4. Legal status and opposition records. USPTO.
5. Regional patent filings (EPO, JPO, SIPO).

Drugs Protected by US Patent 9,017,731

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Neos Theraps Inc	ADZENYS ER	amphetamine	SUSPENSION, EXTENDED RELEASE;ORAL	204325-001	Sep 15, 2017		DISCN	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016	AB	RX	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-002	Jan 27, 2016	AB	RX	Yes	No			Y
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-003	Jan 27, 2016	AB	RX	Yes	No			Y

International Family Members for US Patent 9,017,731

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2726066
World Intellectual Property Organization (WIPO)	2013003622