Details for Patent: 11,020,388

Which drugs does patent 11,020,388 protect, and when does it expire?

Patent 11,020,388 protects ZUBSOLV and is included in one NDA.

This patent has forty-nine patent family members in thirty-one countries.

Summary for Patent: 11,020,388

Title:	Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Abstract:	There is provided pharmaceutical compositions for the treatment of e.g. opioid dependency comprising microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof, in associative admixture with particles comprising a weak acid, or particles comprising weakly-acidic buffer forming materials. The composition may further comprise a disintegrant and/or particles of a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof. The compositions are to useful in the treatment of opioid dependency/addiction and/or pain.
Inventor(s):	Fischer; Andreas (Uppsala, SE)
Assignee:	OREXO AB (Uppsala, SE)
Application Number:	17/033,019
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Detailed Analysis of the Scope and Claims of United States Patent 11,020,388

Introduction

United States Patent 11,020,388, titled "Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence," is a significant patent held by Orexo AB, a company based in Uppsala, Sweden. This patent is crucial in the context of opioid dependence treatment and is protected by a series of patents that ensure its exclusivity in the market.

Patent Overview

The patent, granted on June 1, 2021, pertains to an abuse-resistant pharmaceutical composition designed for the treatment of opioid dependence. This composition is part of a broader family of patents related to Zubsolv, a drug owned by Orexo US Inc.[2].

Claims and Scope

Primary Claims

The patent primarily claims an abuse-resistant pharmaceutical composition that includes a combination of buprenorphine and naloxone. These components are formulated to prevent or reduce the potential for abuse, particularly through non-oral routes such as injection or snorting[1].

Formulation and Administration

The composition is designed to be administered orally, typically in the form of sublingual tablets. The formulation includes specific ratios of buprenorphine and naloxone, along with other excipients that enhance the stability and efficacy of the drug while minimizing its potential for abuse[1].

Abuse Resistance

A key aspect of this patent is the incorporation of abuse-deterrent features. These include the use of specific excipients and formulations that make the drug less appealing or effective when attempted to be abused through non-oral routes. For example, the composition may include ingredients that cause unpleasant effects if the drug is crushed or dissolved in water[1].

Patent Landscape

Family Patents

The patent 11,020,388 is part of a larger family of patents related to Zubsolv. These patents cover various aspects of the drug, including different dosages, modes of administration, and specific formulations designed to prevent abuse. There are 11 US drug patents filed from 2013 to 2022, with 10 of them currently active[2].

Expiry Dates

The active patents related to Zubsolv are set to expire in September 2032, providing Orexo with exclusive rights to the market for several more years. This exclusivity period is critical for maintaining market dominance and preventing generic competition[2].

International Protection

While the US patents provide insights into exclusivity within the United States, Zubsolv is also protected by patents in multiple countries. Understanding the global patent landscape is essential for strategizing market entry and identifying potential generic entry points in regions with weaker patent protection[2].

Legal and Regulatory Aspects

Maintenance Fees and Legal Status

The patents associated with Zubsolv have undergone various legal and administrative processes, including the payment of maintenance fees and litigation. For instance, patents like US9439900 and US9259421 have been involved in litigation, highlighting the ongoing efforts to protect the intellectual property[2].

Exclusivity Periods

In addition to patent protection, Zubsolv may also benefit from exclusivity periods granted by the FDA. These periods can run simultaneously with patent protection and can range from 180 days to seven years, depending on the circumstances of the exclusivity grant[5].

Impact on Market and Competition

Market Dominance

The robust patent protection and exclusivity periods ensure that Orexo maintains significant market dominance for Zubsolv. This exclusivity prevents generic versions of the drug from entering the market, allowing Orexo to retain its market share and pricing power[5].

Generic Competition

As of now, there is no therapeutically equivalent generic version of Zubsolv available in the United States. The absence of generic competition is directly attributed to the strong patent and exclusivity protection surrounding the drug[5].

Innovation and Public Health

Abuse Deterrence

The innovation represented by this patent is crucial in the context of public health, particularly in addressing the opioid epidemic. The abuse-resistant features of Zubsolv help in reducing the misuse of opioids, which is a significant public health concern[1].

Treatment Efficacy

The composition and formulation of Zubsolv, as protected by this patent, have been designed to ensure efficacy in treating opioid dependence while minimizing the risk of abuse. This balance is critical for effective treatment and patient safety[1].

Key Takeaways

• Patent Protection: United States Patent 11,020,388 is part of a comprehensive patent strategy that protects Zubsolv's formulation and administration.
• Abuse Resistance: The patent focuses on abuse-resistant features to prevent misuse of the opioid treatment drug.
• Exclusivity: The drug benefits from both patent protection and FDA-granted exclusivity periods.
• Market Impact: The strong patent and exclusivity protection ensure Orexo's market dominance and prevent generic competition.
• Public Health: The innovation is significant in addressing the opioid epidemic by reducing the potential for abuse.

FAQs

1. What is the primary focus of United States Patent 11,020,388?

The primary focus is on an abuse-resistant pharmaceutical composition for the treatment of opioid dependence, specifically combining buprenorphine and naloxone.

2. How does the patent protect against abuse?

The patent includes formulations and excipients that make the drug less appealing or effective when attempted to be abused through non-oral routes.

3. What is the current status of generic versions of Zubsolv?

There is currently no therapeutically equivalent generic version of Zubsolv available in the United States due to strong patent and exclusivity protection.

4. When do the patents related to Zubsolv expire?

The active patents related to Zubsolv are set to expire in September 2032.

5. How does the patent impact the market and competition?

The patent ensures Orexo's market dominance by preventing generic competition and maintaining exclusivity in the market.

Sources

1. United States Patent and Trademark Office. Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence. US Patent 11,020,388 B2, June 1, 2021.
2. Pharsight. Zubsolv patent expiration. Retrieved from https://pharsight.greyb.com/drug/zubsolv-patent-expiration
3. United States Patent and Trademark Office. Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. Google Patents. A pharmaceutical composition. EP Patent 0324725 A1, Retrieved from https://patents.google.com/patent/EP0324725A1/es
5. Drugs.com. Generic Zubsolv Availability. Retrieved from https://www.drugs.com/availability/generic-zubsolv.html

Drugs Protected by US Patent 11,020,388

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016		RX	Yes	No	11,020,388		Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013		RX	Yes	No	11,020,388		Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No	11,020,388		Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	11,020,388		Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No	11,020,388		Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes	11,020,388		Y			USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE

International Family Members for US Patent 11,020,388

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012311293
Australia	2013245546
Brazil	112014006356
Canada	2834327
Chile	2014000575
China	103813785
Colombia	6960541