Details for Patent: 9,522,188

Which drugs does patent 9,522,188 protect, and when does it expire?

Patent 9,522,188 protects BUNAVAIL and is included in one NDA.

This patent has eight patent family members in seven countries.

Summary for Patent: 9,522,188

Title:	Abuse resistant transmucosal drug delivery device
Abstract:	The present invention relates to a solid pharmaceutical dosage form for abusable drug delivery with reduced illicit abuse potential. The dosage form is presented as a bioerodable transmucosal delivery device that includes an abusable drug and an antagonist to the abusable drug associated with an abuse-resistant matrix. The devices of the invention may be in the form of a layered film or a tablet. Upon application in a non-abusive manner, the device adheres to the mucosal surface, providing transmucosal drug delivery of the drug with minimal absorption of the antagonist into systemic circulation.
Inventor(s):	Andrew Finn, Niraj Vasisht
Assignee:	Biodelivery Sciences International Inc
Application Number:	US11/639,408
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,522,188
Patent Claim Types: see list of patent claims	Use; Delivery; Device;

US Patent 9,522,188: Abuse-Resistant Transmucosal Drug Delivery Device Patent Scope and Landscape

US Patent 9,522,188 protects a bioerodable transmucosal film or layered device that combines an abusable drug, such as an opioid, with an antagonist, such as naloxone, in a structure designed to deliver the drug through mucosal tissue while limiting antagonist absorption during therapeutic use. The patent’s strongest protection is directed to the combination of: a mucoadhesive drug-containing layer, an antagonist-containing abuse-resistant matrix, bioerodability, and functional abuse-deterrence performance.

The patent is primarily a drug-delivery platform patent. It does not, based on the claims supplied, protect a particular marketed drug, dosage strength, active pharmaceutical ingredient, or commercial product by name. Its practical value depends on whether a competing product uses the claimed layer architecture and whether the antagonist remains substantially transmucosally unavailable during intended administration.

What does US Patent 9,522,188 cover?

The patent covers abuse-resistant transmucosal delivery devices containing an abusable drug and an antagonist in separate or partially integrated structural components.

The core architecture in independent claim 1 requires:

1. An abusable drug incorporated into a mucoadhesive layer.
2. An antagonist incorporated into an abuse-resistant matrix.
3. The antagonist to be “substantially transmucosally unavailable.”
4. The device to be bioerodable.

The claim is not limited to buprenorphine, oxycodone, hydrocodone, fentanyl, or any single opioid. Claim 11 broadly identifies opiates and opioids, while claim 12 lists a large group of specific drugs and related salts, bases, derivatives, and physiologically acceptable compounds.

The claimed device can be a dissolving oral film, buccal film, sublingual film, or other bioerodable transmucosal dosage form, provided the product satisfies the structural and functional limitations.

Independent claims

Claim	Subject matter	Commercial significance
1	Bioerodable abuse-resistant transmucosal device with abusable drug in a mucoadhesive layer and antagonist in an abuse-resistant matrix	Broadest device claim
17	Method of treating pain using a device covered by the preceding claims	Method-of-use protection
20	Bioerodable layered film with mucoadhesive and non-adhesive backing layers, with antagonist in one or more layers	Layered-film product claim

Claim 20 is particularly important for film products because it expressly recites a layered film with a bioerodable mucoadhesive layer and a bioerodable non-adhesive backing layer.

How broad is claim 1 of US 9,522,188?

Claim 1 is broad in active-ingredient scope but narrower in formulation architecture and functional performance.

Broad elements

The claim does not require:

• A particular opioid;
• A particular antagonist;
• A specific antagonist-to-drug ratio;
• A specific mucosal site;
• A particular polymer;
• A particular film thickness;
• A specific residence time;
• A specified release rate;
• A specific therapeutic indication.

The claim therefore potentially reaches products containing different opioid-antagonist combinations, including combinations not marketed when the patent was filed.

Limiting elements

A product would need to satisfy each of the following limitations:

• The abusable drug must be incorporated into a mucoadhesive layer.
• The antagonist must be incorporated into an abuse-resistant matrix.
• The antagonist must be substantially transmucosally unavailable during intended use.
• The device must be bioerodable.

A conventional co-formulated tablet, capsule, injectable product, or non-bioerodable patch would not fall within claim 1 merely because it contains an opioid and antagonist.

A product in which the antagonist is freely available for transmucosal absorption during normal administration may also avoid the claim, depending on the technical evidence and claim construction.

What formulations are protected by US 9,522,188?

The dependent claims cover multiple layer configurations.

Claim	Formulation configuration
2	Mucoadhesive drug-delivery device
3	Abusable drug and/or abuse-resistant matrix incorporated into the mucoadhesive layer
4	Non-adhesive backing layer
5	Abusable drug in a third layer between mucoadhesive and backing layers
6	Abuse-resistant matrix in a third layer
7	Abuse-resistant matrix itself forms the third layer
8	Matrix incorporated into the mucoadhesive layer and/or backing layer
9	Matrix incorporated into the backing layer
10	Matrix erodes more slowly than one or more other layers
20	Layered film with bioerodable mucoadhesive and non-adhesive backing layers
21	Residence time of approximately 20 minutes to four hours

The patent therefore covers both integrated and multilayer designs. The antagonist matrix may be:

• Embedded in the mucoadhesive layer;
• Embedded in a separate intermediate layer;
• Formed as a separate layer;
• Embedded in the backing layer;
• Distributed across multiple layers.

Claim 10 adds a relative erosion-rate limitation. It is directed to a matrix that erodes more slowly than the backing layer, mucoadhesive layer, third layer, or combination of those layers. This claim could be relevant to products engineered to retain the antagonist after the therapeutic drug-containing layer has eroded.

What drugs and antagonists are covered?

Claim 12 identifies a broad list of abusable drugs. The list includes:

• Buprenorphine;
• Codeine;
• Fentanyl;
• Hydrocodone;
• Hydromorphone;
• Methadone;
• Morphine;
• Oxycodone;
• Oxymorphone;
• Remifentanil;
• Sufentanil;
• Tramadol;
• Other listed opiates, opioids, stimulants, and related compounds.

The list also includes compounds such as modafinil, mazindol, fencamfamine, and fenethylline. Those inclusions broaden the literal enumerated subject matter beyond classical opioid analgesics.

Claim 13 identifies the antagonist group:

• Naloxone;
• Naltrexone;
• Nalmefene;
• Nalide;
• Nalmexone;
• Nalorphine;
• Naluphine;
• Cyclazocine;
• Levallorphan;
• Physiologically acceptable salts and solvates.

The claims are not limited to the combination of buprenorphine and naloxone. That distinction matters in freedom-to-operate analysis. A product using oxycodone/naltrexone or hydromorphone/nalmefene could raise the same claim issues if its formulation meets the structural and functional limitations.

What is the abuse-deterrence mechanism?

The claimed mechanism separates therapeutic delivery from abuse-related delivery.

During intended administration, the abusable drug is available from the mucoadhesive layer for transmucosal absorption. The antagonist is placed in an abuse-resistant matrix so that it is substantially unavailable through the mucosa.

During abusive dissolution, the claims contemplate release of both the antagonist and the abusable drug. Claims 14 and 15 require the antagonist and abusable drug to be released at substantially the same rate when the device is abusively dissolved or dissolved in water. Claim 16 requires a released antagonist-to-drug ratio of at least approximately 1:20.

This creates two distinct performance conditions:

Use condition	Claimed outcome
Intended transmucosal use	Drug is delivered; antagonist is substantially transmucosally unavailable
Abusive dissolution	Antagonist and drug are released at substantially similar rates
Water dissolution	Antagonist and drug are released at substantially similar rates
Method of treatment	Antagonist systemic absorption is less than approximately 15% by weight

The claims do not require complete prevention of abuse. They require a formulation designed to make abuse less attractive or pharmacologically counteracted by exposing the abuser to the antagonist.

What is the importance of claims 14 through 18?

Claims 14 through 18 convert the abuse-deterrence concept into measurable performance limitations.

Release-rate limitations

Claims 14 and 15 require substantially similar release rates in abusive dissolution or water. The phrase “substantially the same rate” would likely require comparative dissolution data, analytical methods, and a defined testing protocol in an infringement dispute.

Ratio limitation

Claim 16 requires a released antagonist-to-abusable-drug ratio of at least about 1:20. This is a relatively permissive lower threshold. A product releasing one part antagonist for every 20 parts abusable drug, or a higher antagonist proportion, could potentially satisfy the claim if the other limitations are met.

Systemic absorption limitation

Claim 18 requires antagonist absorption into systemic circulation of less than about 15% by weight. This limitation applies to the method-of-treatment claim, not directly to the device claims. It may be difficult to establish through routine product testing because the analysis would require a defined administered dose, sampling schedule, bioanalytical method, and calculation of absorbed antagonist.

Dosage range

Claim 19 covers an abusable-drug dosage between approximately 50 micrograms and 10 milligrams. The range is broad enough to cover many transmucosal opioid doses, but a product outside the range could still implicate claim 1 or claim 20.

When does US Patent 9,522,188 lose exclusivity?

US Patent 9,522,188 issued on December 20, 2016. Its enforceable term depends on the earliest relevant nonprovisional filing date, continuity data, patent-term adjustment, patent-term extension, terminal disclaimers, and maintenance-fee status. A 20-year term is generally measured from the earliest effective nonprovisional filing date under 35 U.S.C. § 154, subject to statutory adjustments.[2]

The patent should not be treated as a drug-specific Orange Book exclusivity right. Its expiration date is not established by the claims alone. The controlling date is the USPTO term calculation for the issued patent and its priority chain.[1][3]

Patent expiration and FDA exclusivity are separate:

Right	Relevance to US 9,522,188
Patent term	Determines enforceability of the issued claims
FDA new chemical entity exclusivity	Does not arise from this device patent
FDA three-year exclusivity	Applies to qualifying approval changes, not the patent itself
Orphan-drug exclusivity	Depends on product and indication
Orange Book listing	Requires listing by an NDA holder for an approved drug product
Paragraph IV certification	Applies to an ANDA applicant challenging a listed patent

What is the Orange Book status of US Patent 9,522,188?

US Patent 9,522,188 is a formulation and delivery-device patent. It is not automatically an Orange Book-listed patent.

The FDA Orange Book generally lists patents submitted by an approved NDA holder for a specific approved drug product. A platform patent covering a class of transmucosal films may be absent from the Orange Book unless the patent was properly submitted and accepted for a particular NDA product.[4]

The patent therefore does not, by itself, establish an FDA regulatory barrier to an ANDA applicant. Its relevance to an ANDA would depend on whether:

1. The patent is listed against the reference listed drug;
2. The proposed generic product falls within one or more claims;
3. The applicant makes a Paragraph IV certification;
4. The NDA holder files an infringement action within the statutory period.

A product-specific patent listing for buprenorphine/naloxone film should be analyzed separately from US 9,522,188.

Are there Paragraph IV challenges involving US 9,522,188?

The patent number alone does not establish a Paragraph IV challenge. Paragraph IV litigation is product-specific and depends on the patent’s listing against an NDA and the ANDA applicant’s certification.

For opioid transmucosal films, the most commercially relevant litigation has involved patents associated with Suboxone and buprenorphine/naloxone products. Those disputes have included Orange Book-listed formulation and delivery patents, patent-term issues, and generic applicants seeking approval for buprenorphine/naloxone films. The existence of that litigation does not establish that US 9,522,188 was asserted or listed in the same proceedings.

The correct legal distinction is:

• US 9,522,188: broad abuse-resistant transmucosal platform claims.
• Orange Book patents: product-linked patents submitted for a particular NDA.
• Paragraph IV litigation: litigation triggered by an ANDA certification concerning a listed patent.

Which companies may be exposed to this patent?

The most exposed companies would be those developing opioid or controlled-substance transmucosal films with an antagonist physically separated from the active drug during therapeutic use.

Potentially relevant product categories include:

• Buprenorphine/naloxone buccal or sublingual films;
• Opioid analgesic films containing naloxone or naltrexone;
• Fentanyl or sufentanil transmucosal films with abuse-deterrent antagonist systems;
• Hydrocodone, oxycodone, or hydromorphone films with antagonist-containing matrices;
• Layered polymeric films with slow-eroding backing or intermediate layers.

Exposure is lower for:

• Tablets and capsules;
• Injectable products;
• Non-bioerodable patches;
• Films without antagonists;
• Products in which the antagonist is fully transmucosally available during intended use;
• Products using a mechanical abuse-deterrence mechanism without an antagonist;
• Products using a non-mucoadhesive delivery system.

How strong is the patent estate for US 9,522,188?

The patent has meaningful platform breadth but several potential validity and enforcement pressure points.

Strengths

• Claim 1 covers a broad class of abusable drugs and antagonists.
• The claims cover multiple layer arrangements.
• Claim 20 expressly targets layered films.
• The patent includes both structural and functional abuse-resistance limitations.
• Claims 14 through 16 provide quantitative release-performance concepts.
• Claim 21 captures clinically practical mucosal residence times.

Vulnerabilities

• “Substantially transmucosally unavailable” may require fact-intensive claim construction.
• “Abuse-resistant matrix” may depend on specification-defined materials and performance.
• “Substantially the same rate” may create testing disputes.
• The claim combination may face obviousness arguments based on known opioid-antagonist combinations, mucoadhesive films, and abuse-deterrent formulations.
• Broad drug lists do not eliminate the need to prove every structural limitation.
• Method claim 18 requires evidence of antagonist systemic absorption below a quantitative threshold.
• A competitor may avoid infringement by changing the location, availability, erosion profile, or release behavior of the antagonist.

The strongest enforcement position would likely involve a product with a multilayer bioerodable film, an opioid in the mucoadhesive layer, naloxone or a related antagonist in a slow-eroding matrix, and dissolution data showing co-release during tampering.

What generic entry risks exist?

A generic or follow-on product faces different risks depending on its dosage form.

Product design	Risk under US 9,522,188
Buprenorphine/naloxone layered film	High if antagonist is masked during normal use and released during dissolution
Buprenorphine-only film	Lower under the supplied claims because an antagonist is required
Oxycodone/naltrexone film	Potentially high if all structural limitations are met
Single-layer film with both actives uniformly distributed	Depends on whether the antagonist is in an abuse-resistant matrix
Tablet containing opioid and antagonist	Generally outside the transmucosal device claims
Non-bioerodable patch	Generally outside the bioerodable-device claims
Film with antagonist fully available through mucosa	Potentially avoids the “substantially transmucosally unavailable” limitation
Film using an antagonist only in a removable external coating	Requires claim-by-claim analysis

A generic applicant could pursue a Paragraph IV strategy if the patent is listed and the applicant can assert noninfringement, invalidity, or unenforceability. If the patent is not listed for the reference product, it may still create ordinary patent-litigation risk but would not necessarily support a statutory Paragraph IV stay.

What design-arounds are available?

Potential design-arounds include:

1. Removing the antagonist entirely.
2. Using a non-mucoadhesive dosage form.
3. Using a non-bioerodable backing or delivery structure.
4. Placing the antagonist in a configuration that remains transmucosally available during intended use.
5. Using a mechanical abuse-deterrent matrix without a pharmacologic antagonist.
6. Designing the antagonist and opioid to have materially different dissolution profiles.
7. Using a dosage form that does not include the claimed mucoadhesive and backing-layer arrangement.
8. Selecting a therapeutic dose outside the claim 19 range while assessing the broader device claims separately.
9. Using an antagonist not within claim 13 and evaluating whether it is captured by broader claim language or equivalents.
10. Engineering the formulation so the antagonist is not incorporated into an “abuse-resistant matrix.”

Design-arounds must be evaluated against claim 1 and claim 20 first. Avoiding dependent claim 10, 16, 19, or 21 does not avoid infringement if an independent claim is met.

How does US 9,522,188 compare with product-specific opioid-film patents?

US 9,522,188 is broader in platform concept than a patent limited to a named commercial formulation, but it may be narrower in technical requirements.

Characteristic	US 9,522,188	Product-specific opioid-film patent
Active ingredient	Broad classes and lists	Often limited to named drugs
Dosage form	Bioerodable transmucosal device	May target a specific film or composition
Antagonist	Broad antagonist list	Often fixed, such as naloxone
Layer structure	Central claim requirement	May be broader or narrower
Abuse deterrence	Functional and structural	May focus on polymer, ratio, or release
Orange Book relevance	Not automatic	Often stronger if listed for an NDA
FTO impact	Platform-level	Product-level
Generic challenge	Depends on listing and claim scope	Often directly tied to ANDA approval

The patent should therefore be analyzed as one layer of a broader estate. A commercial product may face separate patents covering polymer composition, film manufacturing, dosing, active-ingredient particle size, stabilizers, release profiles, packaging, and therapeutic use.

What patent litigation and licensing issues matter?

The commercial value of this patent depends on ownership, chain of title, licenses, and related family members. A platform patent may be licensed to a product developer without appearing as the product’s principal Orange Book patent.

Relevant diligence areas include:

• Assignment records;
• Continuation and divisional applications;
• Terminal disclaimers;
• Maintenance-fee payments;
• Patent-term adjustment;
• Foreign counterparts;
• Exclusive or nonexclusive licenses;
• Joint-development agreements;
• Settlement agreements involving opioid-film products;
• Covenants not to sue;
• Field-of-use restrictions;
• Sublicense rights and change-of-control provisions.

A settlement covering a specific buprenorphine/naloxone product does not necessarily grant freedom to operate for a different opioid, antagonist, indication, or delivery platform.

What is the geographic coverage?

US Patent 9,522,188 provides protection only in the United States. International risk must be assessed through corresponding applications in jurisdictions such as:

• Europe;
• Canada;
• Australia;
• Japan;
• China;
• South Korea;
• Brazil;
• Mexico.

Foreign counterparts may have different claim scope, prosecution history, expiration dates, opposition outcomes, and lapse status. European claims, in particular, may be narrower after examination or opposition than the issued US claims.

Key Takeaways

• US 9,522,188 is a platform patent for bioerodable abuse-resistant transmucosal drug-delivery devices.
• Claim 1 requires an abusable drug in a mucoadhesive layer and an antagonist in an abuse-resistant matrix.
• Claim 20 is directed specifically to layered bioerodable films with mucoadhesive and backing layers.
• The patent covers broad opioid and antagonist classes, not only buprenorphine and naloxone.
• The antagonist must be substantially transmucosally unavailable during intended use.
• Claims 14 through 16 add dissolution and release-ratio requirements relevant to abuse testing.
• The patent is not automatically an Orange Book-listed patent.
• Paragraph IV exposure depends on product-specific listing and ANDA certification.
• The principal FTO risk concerns opioid films with masked antagonists and multilayer bioerodable architectures.
• Design-arounds focus on antagonist placement, transmucosal availability, erosion profile, layer structure, and non-antagonist abuse-deterrence mechanisms.
• Patent expiration must be determined from the USPTO continuity, term-adjustment, disclaimer, and maintenance-fee records rather than from the claims alone.

FAQs

Does US 9,522,188 cover Suboxone film?

It may be technically relevant to a buprenorphine/naloxone film, but the patent number alone does not establish infringement, Orange Book listing, or enforcement against Suboxone. The product must be compared element-by-element with claims 1 and 20.

Does the patent cover naloxone in any dosage form?

No. The claims require a bioerodable transmucosal delivery device and an abuse-resistant matrix that makes the antagonist substantially transmucosally unavailable during intended use.

Can a product avoid the patent by using naltrexone instead of naloxone?

Not necessarily. Claim 13 expressly includes naltrexone. Substitution must be evaluated against the full claim, including device structure, bioerodability, antagonist availability, and release behavior.

Does a patent covering an opioid film automatically block FDA approval?

No. FDA approval and patent enforcement are separate. A listed patent may trigger a Paragraph IV certification and possible litigation, while an unlisted patent may still support an infringement action outside the Orange Book stay mechanism.

What technical data would be most important in an infringement dispute?

The most important data would include layer composition, microscopy or cross-sectional analysis, drug and antagonist location, erosion behavior, mucosal absorption, dissolution profiles in water and abuse-relevant solvents, released antagonist-to-drug ratios, and systemic antagonist exposure.

References

1. United States Patent and Trademark Office. (2016). US Patent No. 9,522,188, Abuse-resistant transmucosal drug delivery device. https://patents.google.com/patent/US9522188B2/en
2. 35 U.S.C. § 154. Patent term. https://www.law.cornell.edu/uscode/text/35/154
3. United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
5. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application submissions and Paragraph IV certifications. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/anda-submissions-and-paragraph-iv-certifications

Drugs Protected by US Patent 9,522,188

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014		DISCN	Yes	No			Y

International Family Members for US Patent 9,522,188

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006326377
Brazil	PI0619806
Canada	2629046
China	101330903