Details for Patent: 9,687,454

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Which drugs does patent 9,687,454 protect, and when does it expire?

Patent 9,687,454 protects SUBOXONE and is included in one NDA.

This patent has thirty-one patent family members in twenty-three countries.

Summary for Patent: 9,687,454

Title:	Sublingual and buccal film compositions
Abstract:	The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form.
Inventor(s):	Garry L. Myers, Samuel D. Hilbert, Bill J. Boone, Beuford Arlie Bogue, Pradeep Sanghvi, Madhusudan Hariharan
Assignee:	Indivior UK Ltd
Application Number:	US14/989,669
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,687,454
Patent Claim Types: see list of patent claims	Use;

United States Patent 9,687,454: Claim Scope, Suboxone Film Protection, and Generic Entry Risk

U.S. Patent 9,687,454 protects a narrow buprenorphine/naloxone oral film defined by composition, dosage ratios, polymer content, acidic buffering, mucoadhesion, and pharmacokinetic performance. The patent is directed to the sublingual or buccal film technology used for buprenorphine/naloxone opioid-dependence treatment, including Suboxone sublingual film. Its principal commercial value is the combination of a 4:1 buprenorphine-to-naloxone ratio with specified polymer, buffer, dose, and absorption parameters.

The patent does not broadly cover every buprenorphine/naloxone film. A competing product that avoids the claimed numerical ranges, uses a materially different formulation, or fails to meet the claimed pharmacokinetic limitations may reduce infringement risk. The listed patent term extends to 2027, based on the patent-family expiration date reflected in U.S. patent and FDA records.[1][2]

What does U.S. Patent 9,687,454 protect?

The independent composition claim protects an oral, self-supporting, mucoadhesive film containing:

Claim element	Required limitation
Dosage form	Oral, self-supporting mucoadhesive film
Site of administration	Sublingual or buccal mucosa
Polymer matrix	About 40 wt% to about 60 wt% water-soluble polymer
Buprenorphine	About 2 mg to about 16 mg
Naloxone	About 0.5 mg to about 4 mg
Drug ratio	Buprenorphine:naloxone of about 4:1
Buffer	Acidic buffer
Buffer-to-buprenorphine ratio	2:1 to 1:5
Buprenorphine exposure	Cmax of about 0.624 to 5.638 ng/mL; AUC of about 5.431 to 56.238 hr·ng/mL
Naloxone exposure	Cmax of about 41.04 to 323.75 pg/mL; AUC of about 102.88 to 812.00 hr·pg/mL

A product generally must satisfy every limitation of an asserted claim for literal infringement. The claim is therefore materially narrower than a claim directed simply to “a sublingual film containing buprenorphine and naloxone.”

How should claim 1 be construed?

Claim 1 combines structural, compositional, ratio, and functional limitations. The principal claim-construction issues are below.

“Oral, self-supporting mucoadhesive film”

The claim requires a film that can be handled and applied without a separate tablet, lozenge, backing layer, or external support. The film must adhere to sublingual or buccal mucosa.

A dissolving tablet, conventional oral tablet, liquid, spray, implant, or transdermal system would not ordinarily satisfy this limitation. A multilayer film could fall within the claim if the finished dosage form remains a self-supporting mucoadhesive film and contains the claimed components.

“About” and numerical ranges

The claim repeatedly uses “about.” In patent practice, “about” can provide some tolerance around a numerical boundary, but it does not eliminate the importance of the stated ranges. The scope would depend on the specification, prosecution history, and ordinary technical meaning.

The important boundaries are:

• Polymer: approximately 40% to 60% by weight.
• Buprenorphine dose: approximately 2 mg to 16 mg.
• Naloxone dose: approximately 0.5 mg to 4 mg.
• Buprenorphine:naloxone: approximately 4:1.
• Buffer:buprenorphine: 2:1 to 1:5.
• Pharmacokinetic exposure: the stated Cmax and AUC windows for both drugs.

A formulation outside one range may avoid literal infringement, although the result would depend on how the court construes “about” and whether equivalents are available.

“Differing absorption”

The claim requires differential absorption between buprenorphine and naloxone. This limitation reflects the intended pharmacology of the combination: substantial systemic buprenorphine exposure with relatively limited naloxone exposure when administered sublingually or buccally.

The claim does not merely require the presence of both drugs. It requires the claimed exposure ranges for each drug. Those limits can make the claim commercially powerful against a directly substitutable product, but they also create proof issues. An infringement analysis would likely require formulation information, clinical pharmacokinetic data, or testing of representative commercial batches.

What do dependent claims 2 through 14 add?

The dependent claims create narrower fall-back positions around the buffer, polymer, and formulation.

Claims	Added limitation	Commercial significance
2	Buffer:buprenorphine ratio of about 1:1 to 1:5	Excludes the higher-buffer portion of claim 1
3	Buffer:buprenorphine ratio of about 1.4:1 to 1:3	More specific buffer range
4	Citric acid as acidic buffer	Protects a commercially practical buffer species
5	Buprenorphine:polymer ratio of about 1:3 to 1:11.5	Limits drug loading relative to polymer
6	Buprenorphine:polymer ratio of about 1:3	Narrow formulation target
7	Polymer content of about 48.2 wt% to 58.6 wt%	Narrows the matrix concentration
8	Polymer content of about 48.2 wt%	Protects a specific composition point
9	Polyethylene oxide alone or with hydrophilic cellulosic polymer	Identifies the principal matrix architecture
10	Hydroxypropyl cellulose, hydroxypropylmethyl cellulose, or both	Narrows the cellulosic component
11	Hydroxypropylmethyl cellulose	Most specific cellulosic polymer claim
12	Combined buffer, drug-to-polymer, and polymer-content limitations	Strongest formulation-specific fall-back claim
13	Treating opioid dependence by sublingual or buccal administration	Method-of-treatment protection
14	Buffer:buprenorphine ratio of 2:1 to 1:1	Protects the higher-buffer segment of claim 1

Claim 12 is particularly important because it combines multiple formulation limitations. A generic that avoids claim 1 by modifying one parameter may still face a narrower claim if it retains the claimed buffer ratio, polymer ratio, and polymer concentration.

What formulations are protected by the patent?

The patent’s strongest formulation coverage concerns films having a water-soluble polymer matrix based on polyethylene oxide, alone or combined with hydroxypropyl cellulose or hydroxypropylmethyl cellulose. Claim 11 specifically identifies hydroxypropylmethyl cellulose.

The protected formulation concept can be summarized as:

1. A self-supporting film rather than a conventional solid oral dosage form.
2. A water-soluble polymer matrix in a mid-range concentration.
3. Buprenorphine and naloxone in an approximately 4:1 ratio.
4. An acidic buffer, with citric acid expressly covered.
5. Sublingual or buccal adhesion.
6. Differential buprenorphine and naloxone absorption.

The claims do not require every excipient used in a commercial Suboxone film. A formulation could infringe without using the same flavoring, sweetener, plasticizer, pigment, or manufacturing aid, provided it meets the claimed limitations.

Does the patent cover Suboxone sublingual film?

The patent is directed to the same general dosage-form technology as Suboxone sublingual film: buprenorphine hydrochloride and naloxone hydrochloride delivered through a mucoadhesive oral film. Suboxone sublingual film was approved under NDA 022410 in 2010.[3]

The 4:1 drug ratio in the patent corresponds to the established Suboxone combination ratio. That ratio alone does not establish infringement. The product must also fall within the polymer, buffer, dosage, mucoadhesion, and pharmacokinetic limitations.

The relevant product distinction is:

Product characteristic	Patent 9,687,454	Generic or competing product assessment
Buprenorphine:naloxone ratio	Approximately 4:1	Likely present in direct Suboxone substitutes
Film dosage form	Required	Must be confirmed
Sublingual/buccal adhesion	Required	Likely for a direct film substitute
Acidic buffer	Required	Formulation-specific
Polymer range	Approximately 40% to 60%	Requires composition analysis
PK ranges	Required	Requires clinical or analytical evidence
NDA/ANDA route	NDA product technology	Direct generic competition proceeds through ANDA

When does U.S. Patent 9,687,454 lose exclusivity?

The patent-family expiration date is September 27, 2027.[1] The patent issued on June 27, 2017. Patent expiration does not itself determine whether a generic can launch earlier because earlier entry may result from:

• A successful Paragraph IV challenge.
• A settlement agreement with an authorized launch date.
• A license from the patent owner.
• A court finding of invalidity or noninfringement.
• Failure to maintain an enforceable listed patent right.

The patent is not a biologic patent. Biosimilar exclusivity concepts under the Public Health Service Act do not apply. A competing buprenorphine/naloxone film would ordinarily use the small-molecule ANDA pathway under the Federal Food, Drug, and Cosmetic Act.[4]

FDA product exclusivity for the underlying Suboxone film is separate from patent exclusivity. The product’s regulatory exclusivity period has expired. The remaining barrier is primarily patent and regulatory approval risk, not new-drug exclusivity.

What is the Orange Book status of the patent?

The FDA Orange Book is the controlling source for listed patents and use codes associated with approved drug products.[2] Patent 9,687,454 is associated with the Suboxone film patent estate and should be evaluated together with other patents listed for buprenorphine/naloxone sublingual film.

Orange Book analysis should distinguish:

• The patent number.
• The listed expiration date.
• The NDA to which the patent is attached.
• Any use code.
• Whether the patent is directed to the drug substance, formulation, method of use, or another approved-product feature.

A listed patent does not prove that every generic film infringes. It establishes the FDA notice and certification framework for ANDA applicants.

What Paragraph IV challenges affect the patent?

A generic applicant seeking approval before patent expiration can submit a Paragraph IV certification asserting that the listed patent is invalid, unenforceable, or will not be infringed. The NDA holder may then file patent litigation within the statutory period, potentially triggering a 30-month stay of approval under the Hatch-Waxman framework.[4]

Suboxone film has been subject to extensive generic competition and patent litigation involving Indivior and ANDA applicants. Publicly reported challengers and generic suppliers have included companies such as Dr. Reddy’s Laboratories, Teva, Mylan, and Alvogen, although the relevant asserted patents and settlement terms differ by proceeding.[5][6]

A Paragraph IV case directed only to one patent does not resolve the entire estate. Generic entry can remain blocked by other listed patents, formulation patents, or settlement restrictions.

Which companies are challenging or competing with Suboxone film?

The commercial field includes:

Company or product group	Role
Indivior	Originator and principal patent holder for Suboxone film
Teva	Generic buprenorphine/naloxone film supplier
Dr. Reddy’s Laboratories	Generic ANDA applicant and supplier
Mylan/Viatris	Generic competitor
Alvogen	Generic competitor and ANDA participant
Zydus and other ANDA sponsors	Potential or approved generic competition depending on product and timing

The relevant competitive threat is not biosimilar substitution. It is ANDA-based generic substitution for a small-molecule combination product.

How strong is the patent estate for Suboxone film?

Patent 9,687,454 has moderate-to-strong value against a direct copy but narrower value against redesigned films.

Strengths

• It covers the clinically established 4:1 buprenorphine:naloxone ratio.
• It requires a film rather than a less comparable dosage form.
• It combines composition and pharmacokinetic limitations.
• It includes polymer-specific claims directed to polyethylene oxide and cellulosic polymers.
• It has narrower claims that may correspond closely to a commercial formulation.
• The patent term extends beyond the period when most generic development decisions are made.

Weaknesses

• The claim contains numerous cumulative limitations.
• The “about” ranges can create claim-construction disputes.
• The PK limitations may require testing and may vary between subjects, batches, and study protocols.
• A generic can pursue design-around strategies involving polymer content, buffer selection, dose, drug ratio, or release and absorption behavior.
• The method claim is limited to treating opioid dependence using the claimed film.

The patent is strongest when the accused product is a direct formulation copy. It is weaker against a product engineered outside the claimed numerical and compositional architecture.

What generic launch scenarios exist?

Launch after patent expiration

The clearest pathway is commercial launch after September 27, 2027, assuming FDA approval and no other enforceable patent barrier.

Launch under a settlement

A generic may receive a licensed or authorized launch date before patent expiration. Settlement terms can include delayed entry, authorized generic arrangements, supply provisions, or restrictions tied to particular patents. Settlement documents and court dockets must be reviewed separately because a settlement involving one patent may not cover the entire estate.

Launch after a successful Paragraph IV case

A generic may launch if the asserted patent is found invalid, unenforceable, or not infringed and no other barrier remains. The risk is highest where the generic has a materially different matrix, buffer, polymer concentration, or PK profile.

At-risk launch

A generic may launch before final resolution while accepting potential damages and injunction exposure. This scenario creates the highest commercial uncertainty and is uncommon where the originator has multiple listed patents.

What manufacturing and intellectual-property barriers remain?

Manufacturing a mucoadhesive film that consistently meets the claimed PK ranges is more difficult than reproducing the 4:1 drug ratio. Key technical variables include:

• Polymer molecular weight and viscosity.
• Film thickness and weight uniformity.
• Drug dispersion and content uniformity.
• Drying conditions.
• Moisture content.
• Buffer concentration and local pH.
• Mucoadhesion time.
• Dissolution and disintegration behavior.
• Sublingual versus buccal absorption.
• Batch-to-batch pharmacokinetic variability.

The patent therefore creates both legal and development barriers. A design-around may avoid one compositional limitation but produce a product that is less comparable to the reference listed drug, complicating bioequivalence and commercial substitution.

How does Patent 9,687,454 compare with broader Suboxone patents?

Patent 9,687,454 should be treated as one layer of a larger estate.

Patent category	Typical scope	Risk to generic
Broad film patents	Film architecture, drug incorporation, and oral mucosal delivery	High for any close film substitute
Combination formulation patents	Buprenorphine plus naloxone in defined ratios	High for direct substitutes
Polymer and buffer patents	Specific matrix and excipient combinations	Moderate to high for formulation copies
Method-of-use patents	Opioid-dependence treatment	Relevant to labeling and use
Manufacturing patents	Casting, drying, mixing, and film production	Relevant to process evidence and supply chain
Patent 9,687,454	Narrow composition, ratio, polymer, buffer, and PK combination	Strong against close copies, weaker against engineered alternatives

Key Takeaways

• U.S. Patent 9,687,454 protects a defined buprenorphine/naloxone mucoadhesive film, not all opioid-dependence films.
• The central limitations are the approximately 4:1 drug ratio, acidic buffer, 40% to 60% water-soluble polymer matrix, sublingual or buccal adhesion, and specified PK ranges.
• Polyethylene oxide, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, and citric acid are important dependent-claim targets.
• Claim 12 is the principal multi-parameter formulation fall-back claim.
• The patent is associated with the Suboxone film patent estate and has an expiration date of September 27, 2027.
• Generic competition proceeds through the ANDA and Paragraph IV framework, not the biosimilar pathway.
• A direct copy faces substantial risk, while a redesigned film may avoid literal infringement by changing buffer, polymer content, drug loading, ratio, or PK performance.
• Patent expiration alone does not guarantee launch because other listed patents, settlements, regulatory requirements, or litigation outcomes may remain relevant.

FAQs

Can a film with a 2:1 buprenorphine-to-naloxone ratio infringe Patent 9,687,454?

It would likely fall outside the literal “about 4:1” limitation, subject to construction of “about” and any doctrine-of-equivalents analysis. It could still implicate other patents in the Suboxone estate.

Does using citric acid automatically create infringement?

No. Citric acid is expressly covered by dependent claim 4, but infringement still requires all limitations inherited from claim 1 and claim 3.

Can a generic avoid the patent by using hydroxypropyl cellulose instead of hydroxypropylmethyl cellulose?

Not necessarily. Claim 10 expressly covers hydroxypropyl cellulose, and claim 9 covers polyethylene oxide alone or with a hydrophilic cellulosic polymer.

Are the Cmax and AUC limitations likely to be important in litigation?

Yes. They may require comparative pharmacokinetic testing and could become central to both infringement and non-infringement positions. They also provide a potential design-around target.

Is Suboxone film protected by biologic exclusivity?

No. Buprenorphine/naloxone is a small-molecule combination product. Generic approval proceeds through the ANDA framework rather than the biosimilar pathway.

References

1. U.S. Patent No. 9,687,454. (2017). Mucoadhesive film comprising buprenorphine and naloxone. United States Patent and Trademark Office.
2. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2010). Suboxone sublingual film, NDA 022410: Approval letter and prescribing information.
4. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).
5. Indivior Inc. v. Dr. Reddy’s Laboratories S.A., related Hatch-Waxman patent litigation concerning buprenorphine/naloxone sublingual film. United States District Court records.
6. Indivior Inc. v. Teva Pharmaceuticals USA, Inc., related Hatch-Waxman patent litigation concerning buprenorphine/naloxone sublingual film. United States District Court records.

Drugs Protected by US Patent 9,687,454

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	AB	RX	Yes	No	9,687,454		Y			TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	AB	RX	Yes	No	9,687,454		Y			TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	AB	RX	Yes	No	9,687,454		Y			TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012	AB	RX	Yes	Yes	9,687,454		Y			TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION

International Family Members for US Patent 9,687,454

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	078417
Australia	2010279440
Brazil	112012002817
Canada	2770180
Chile	2012000313