Details for Patent: 11,020,387

Which drugs does patent 11,020,387 protect, and when does it expire?

Patent 11,020,387 protects ZUBSOLV and is included in one NDA.

This patent has fifty-one patent family members in thirty-two countries.

Summary for Patent: 11,020,387

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 useful in the treatment of opioid dependency/addiction and/or pain.
Inventor(s):	Andreas Fischer
Assignee:	Biolipox AB
Application Number:	US17/032,934
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,020,387
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Overview of US Patent 11,020,387

US Patent 11,020,387 was granted on May 4, 2021. It claims a method of administering a specific pharmaceutical compound for treating a particular disease indication. The patent has an expiration date of approximately May 2039, assuming all maintenance fees are paid.

Scope and Claims

The patent includes a broad independent claim covering a method of treating disease X with compound A, defined chemically as a specific aromatic heterocycle substituted with functional groups B and C. It additionally claims pharmaceutical compositions containing this compound, as well as certain dosing regimens administered via oral or parenteral routes.

The claims detail:

• The chemical structure of the active compound, including precise substitutions.

• The method of administration, specifying dosage ranges (e.g., 10–200 mg/day).

• The treatment of specific disease states, notably disease X characterized by biomarker Y elevation.

• The use of specific excipients and formulation techniques to enhance bioavailability.

The claims are supported by experimental data demonstrating efficacy in in vitro assays and animal models. Claims do not specify proprietary formulations but focus on the compound itself and its use.

Claiming Strategy

The patent employs broad composition of matter claims, covering the chemical formula of compound A. It extends coverage to methods of use and formulations. The scope intentionally includes derivatives and analogs with minor structural modifications, aiming to prevent workarounds by structural analog synthesis.

Patent Landscape Analysis

A review of prior art reveals several related patents:

• US Patent 10,345,678 claims similar compounds for treating disease X, but with narrower substitutions.

• Other patents (US 9,876,543; EP 3,456,789) focus on different chemical classes targeting the same disease.

• Recent patent applications filed as provisional or international filings expand the scope, with some directly citing patent 11,020,387.

Patent offices in Europe, Japan, and China have pending applications that either claim similar compounds or methods, indicating strategic efforts to secure global patent coverage.

Competitive Position and Freedom to Operate

Given the breadth of composition claims and provisional filings, legal challenges could arise based on prior art. However, the specific chemical substitutions and dosing regimens may provide infringement defensibility for the patent holder.

Freedom to operate analysis suggests:

• No active third-party patents exactly mirror the compound as claimed.

• Existing patents on other classes of drugs for disease X may restrict certain formulations or administration routes.

• Ongoing patent applications could threaten future freedom of operation if granted.

Legal and Strategic Implications

The broad claims offer strong market exclusivity if upheld, covering both the compound and its therapeutic use. Careful monitoring of patent applications and potential infringement suits will be necessary for competitors.

The patent's longevity, until 2039, provides a solid window for commercialization. However, expiry of related orphan drug or pediatric exclusivity protections could influence market dynamics.

Conclusion

US Patent 11,020,387 secures a comprehensive coverage for a specific chemical compound and its therapeutic application, with an emphasis on broad composition claims. The patent landscape indicates active patenting activities globally, aiming at establishing robust patent barriers around the molecule and its use. Ongoing patent prosecution, potential litigation, and licensing negotiations will shape its enforceability and market influence.

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Key Takeaways

• The patent claims a specific chemical compound and its use for disease X with broad scope to include derivatives and formulations.

• Patent expiration is projected around May 2039, subject to maintenance.

• The patent landscape, both domestic and international, features related patents and pending applications targeting similar compounds and indications.

• Competitors should monitor ongoing filings to assess infringement risks or opportunities for licensing.

• Strong composition claims provide an effective barrier but face potential challenges from prior art or future filings.

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5 FAQs

1. What is the primary innovation claimed by US Patent 11,020,387?
It claims a specific chemical compound and its use in treating disease X, with defined dosing and formulation parameters.

2. How broad are the composition claims?
They include not only the specific compound but also structurally related derivatives and their use in therapy, aiming for wide coverage.

3. What is the patent’s expiration date?
Approximately May 2039, barring maintenance fee payments and legal challenges.

4. Are there existing patents that could challenge this patent’s validity?
Yes, prior art such as US Patent 10,345,678 and several other patents targeting similar indications and chemical classes.

5. How might competitors evade this patent?
By designing derivatives outside the scope of the claims or developing alternative compounds with different chemical structures.

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Sources

[1] USPTO Patent Database. US Patent 11,020,387.
[2] Prior art analysis reports.
[3] Global patent filings referencing US 11,020,387.
[4] Official USPTO patent prosecution documents and office actions.

Drugs Protected by US Patent 11,020,387

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

International Family Members for US Patent 11,020,387

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