Details for Patent: 9,545,380

Which drugs does patent 9,545,380 protect, and when does it expire?

Patent 9,545,380 protects HYSINGLA ER and is included in one NDA.

This patent has two hundred and twenty-one patent family members in forty countries.

Summary for Patent: 9,545,380

Title:	Tamper resistant dosage forms
Abstract:	The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):	McKenna; William H. (Yonkers, NY), Mannion; Richard O. (Furlong, PA), O'Donnell; Edward P. (Basking Ridge, NJ), Huang; Haiyong H. (Princeton, NJ)
Assignee:	PURDUE PHARMA L.P. (Stamford, CT) PURDUE PHARMACEUTICALS L.P. (Wilson, NC)
Application Number:	14/729,688
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,545,380
Patent Claim Types: see list of patent claims	Use; Dosage form; Device;

Understanding the Scope and Claims of United States Patent 9,545,380

To delve into the details of the United States Patent 9,545,380, it is crucial to analyze its scope, claims, and the broader patent landscape in which it resides.

Patent Overview

United States Patent 9,545,380 is associated with pharmaceutical formulations, specifically related to the drug Hysingla® ER (hydrocodone bitartrate), a product of Purdue Pharma. This patent is part of a series of patents asserted by Purdue Pharma in various litigation cases against generic drug manufacturers like Alvogen and Actavis[5].

Claims and Scope

The patent claims typically outline the specific inventions or improvements that the patent protects. For the '380 patent, the claims are likely focused on the formulation, composition, and delivery mechanism of hydrocodone bitartrate.

• Formulation: The patent might detail specific formulations of hydrocodone bitartrate that enhance its efficacy, stability, or bioavailability.
• Composition: Claims could include the exact composition of the drug, including any excipients, binders, or other components that are critical to its function.
• Delivery Mechanism: The patent may cover the method of delivering the drug, such as extended-release formulations, which are a key feature of Hysingla® ER[5].

Patent Landscape Analysis

A comprehensive patent landscape analysis is essential to understand the strategic positioning of the '380 patent within the broader pharmaceutical and patent ecosystem.

Competitor Analysis

• Known Competitors: The patent landscape would reveal other companies and entities that have filed similar patents in the same technology area. For instance, generic drug manufacturers like Alvogen and Actavis have been involved in litigation related to this patent, indicating they are significant players in this space[5].
• Emerging Competitors: The analysis might also uncover newer entrants or emerging technologies that could potentially challenge the dominance of Purdue Pharma’s patented formulations.

Technology Trends

• Patent Saturation: A patent landscape analysis would show whether the technology area related to hydrocodone bitartrate formulations is highly saturated. High saturation could indicate a mature technology area where further innovation might be challenging, or it could highlight areas where there is still room for improvement[3].
• Innovation Hotspots: Identifying areas with high patent activity can help in understanding where the industry is focusing its R&D efforts. For example, the increase in electrical engineering patents, particularly in computer technology and digital communication, suggests a broader trend towards technological advancements in these fields[1].

Geographic and Sectoral Distribution

• Geographic Distribution: The patent landscape might show the geographic distribution of patent filings related to hydrocodone bitartrate formulations. This could indicate where the most innovative work is being done and by whom. For instance, the USPTO data shows that patents are often divided between domestic and foreign inventors, with significant contributions from the computer and electronics manufacturing industry[1].
• Sectoral Distribution: The analysis would also reveal the sectors most active in this technology area. In the pharmaceutical sector, businesses and R&D-performing firms are typically the most active in patent filings, with academia and government playing smaller roles[1].

Litigation and Enforcement

The '380 patent has been involved in several litigation cases, which highlights its importance and the competitive landscape in the pharmaceutical industry.

• Patent Infringement Cases: Purdue Pharma has filed multiple complaints against generic drug manufacturers for patent infringement related to this and other associated patents. These cases indicate the company's efforts to protect its intellectual property and maintain market exclusivity[2][5].

Strategic Insights

A thorough patent landscape analysis provides strategic insights that can guide business and R&D decisions.

• Pivot to New Technologies: If the technology area is highly saturated, the analysis might suggest pivoting to newer inventive spaces to maintain a competitive edge[3].
• Resource Allocation: Understanding the focus areas of competitors and the overall patent landscape can help in allocating resources more effectively. For example, identifying a niche technology area where a company is focusing a significant percentage of its resources can inform similar strategic decisions[3].

Key Takeaways

• Patent Claims and Scope: The '380 patent is focused on specific formulations, compositions, and delivery mechanisms of hydrocodone bitartrate.
• Competitor Analysis: The patent landscape reveals known and emerging competitors in the pharmaceutical industry.
• Technology Trends: High patent activity in certain areas can indicate industry trends and innovation hotspots.
• Litigation and Enforcement: The patent has been involved in several litigation cases, highlighting its importance and the competitive landscape.
• Strategic Insights: A comprehensive patent landscape analysis provides valuable insights for business and R&D strategy.

FAQs

Q: What is the main focus of United States Patent 9,545,380?

A: The main focus of the '380 patent is on the formulation, composition, and delivery mechanism of hydrocodone bitartrate, specifically related to Hysingla® ER.

Q: Who are the key competitors in the patent landscape related to this patent?

A: Key competitors include generic drug manufacturers like Alvogen and Actavis, which have been involved in litigation related to this patent.

Q: What does a patent landscape analysis reveal about the technology area of hydrocodone bitartrate formulations?

A: It reveals the level of patent saturation, innovation hotspots, and the strategic focus areas of competitors.

Q: Why is the '380 patent important in the pharmaceutical industry?

A: It is important because it protects Purdue Pharma’s intellectual property related to Hysingla® ER, a significant product in their portfolio.

Q: How can a patent landscape analysis inform business and R&D decisions?

A: It can help in identifying areas for innovation, allocating resources effectively, and making long-term strategic decisions about technology focus areas.

Cited Sources

1. Invention: U.S. and Comparative Global Trends - National Science Foundation.
2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - RPX Corporation.
3. Patent Landscape Analysis - Uncovering Strategic Insights - AcclaimIP.
4. Fatty ester combinations - Patent WO-0009639-A2 - PubChem.
5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - RPX Corporation.

Drugs Protected by US Patent 9,545,380

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No						MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 9,545,380

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062511
Argentina	103463
Argentina	109796