Details for Patent: 9,622,983

Which drugs does patent 9,622,983 protect, and when does it expire?

Patent 9,622,983 protects TROKENDI XR and is included in one NDA.

This patent has eleven patent family members in eight countries.

Summary for Patent: 9,622,983

Title:	Sustained-release formulations of topiramate
Abstract:	Pharmaceutical compositions of topiramate for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined release profile. Method of treating or preventing pathological disorders in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.
Inventor(s):	Likan Liang, Hua Wang, Padmanabh P. Bhatt, Michael L. Vieira
Assignee:	Supernus Pharmaceuticals Inc
Application Number:	US15/259,856
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,622,983
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

US Patent 9,622,983: Topiramate Extended-Release Formulation Claims and Patent Landscape

US Patent No. 9,622,983 protects sustained-release topiramate formulations that combine micronized topiramate with a coated extended-release component and, optionally, an immediate-release component. The patent’s central limitation is pharmacokinetic: the extended-release component must produce a topiramate maximum plasma concentration, or Tmax, either 4 to 8.5 hours after dosing or at least 16 hours after dosing, depending on the claim set. The patent issued April 18, 2017, and is associated with Supernus Pharmaceuticals’ extended-release topiramate franchise, including Trokendi XR.

The strongest infringement risk applies to once-daily or sprinkle formulations using coated topiramate beads or particles and designed to reproduce the claimed plasma exposure profile. A product using uncoated matrix technology, a different active ingredient particle-size distribution, or a materially different Tmax profile may have stronger non-infringement positions, although the complete claim language and prosecution history remain controlling.

What does US Patent 9,622,983 cover?

The patent covers three related subject-matter categories:

1. Sustained-release topiramate formulations.
2. Formulations containing an extended-release component with optional immediate-release topiramate.
3. Methods of treating neurological or psychiatric conditions using those formulations.

The independent formulation claims are claims 1 and 13. Claims 14 and 17 are independent method-of-treatment claims.

Claim group	Covered subject matter	Key pharmacokinetic limitation
Claims 1-12	Sustained-release formulation	XR Tmax of 4 to 8.5 hours
Claims 13, 20-30	Sustained-release formulation	XR Tmax at 16 or more hours
Claims 14-16	Treatment method	XR Tmax of 4 to 8.5 hours
Claims 17-19	Treatment method	XR Tmax at 16 or more hours

The patent does not claim topiramate generally. It claims a defined drug-delivery architecture with particular formulation materials, particle size, release behavior and pharmacokinetic performance.

How is independent claim 1 constructed?

Claim 1 requires all of the following elements:

Limitation	Scope
Active ingredient	Topiramate
Particle size	Micronized particles ranging from 1 to 1,000 micrometers
Release behavior	Topiramate is released immediately and continuously after administration
XR component	A topiramate-containing extended-release component
Coating	Cellulosic or acrylic polymer coating
IR component	Optional
XR pharmacokinetics	Tmax between 4 and 8.5 hours after a single initial dose

The claim is structurally broad because it does not require a particular coating thickness, bead size, polymer concentration, dissolution profile or manufacturing process. It is functionally narrow because the claimed formulation must satisfy the specified in vivo Tmax range.

The phrase “immediately and continuously” applies to the overall release of topiramate. Claim 3 narrows the optional IR component by requiring that 80% of its topiramate be released within one hour. Claim 1 itself does not require an IR component.

What formulations are protected by claim 1?

Claim 1 can cover a capsule or sprinkle product containing coated topiramate beads, with the beads providing extended release and an optional population of uncoated or rapidly dissolving particles providing immediate release.

The coating-polymer genus includes:

• Ethylcellulose
• Methylcellulose
• Hydroxypropyl cellulose
• Hydroxypropylmethyl cellulose
• Cellulose acetate
• Cellulose acetate phthalate
• Polyvinyl alcohol
• Polyacrylates
• Polymethacrylates
• Copolymers of the listed materials

The claim does not require all listed polymers. A formulation using one qualifying cellulosic or acrylic coating can satisfy the coating limitation if the other elements are met.

How does claim 13 differ from claim 1?

Claim 13 repeats most of claim 1 but changes the pharmacokinetic requirement. The XR component must exhibit a Tmax of 16 hours or more after a single initial dose.

That distinction creates two separate PK-defined claim families:

Feature	Claim 1 family	Claim 13 family
XR Tmax	4-8.5 hours	At least 16 hours
IR component	Optional	Optional
Micronized topiramate	Required	Required
Cellulosic or acrylic coating	Required	Required
Capsule or sprinkles	Dependent claim	Dependent claim
80% IR release within one hour	Claim 3	Claim 21

The two families target different release profiles. A product with a Tmax of 10 hours would not fall within either expressly stated XR Tmax range, assuming the court treats the limitations as exclusive numerical boundaries.

What dependent claims add to the patent scope?

The dependent claims add formulation architecture, dosage-form, composition and bioequivalence limitations.

Claims	Added limitation
2, 20	XR component in at least one population of beads
3, 21	IR component releases 80% of topiramate within one hour
4, 22	Binder such as starch, cellulose or polyvinylpyrrolidone
5, 23	Pore former, including sugars, celluloses, polyols, glycols and salts
6, 24	Capsule or sprinkle dosage form
7, 25	Total topiramate amount of 0.5 to 3,000 mg
8, 26	Inert carrier such as cellulose or sugar spheres
9, 27	Specific coating polymers
10, 28	Steady-state Cmax of 50%-125% of equivalent IR topiramate administered twice daily
11, 29	Relative steady-state AUC of 80%-125% of equivalent IR topiramate administered twice daily
12, 30	Additional active ingredient

Claims 10 and 11 are particularly relevant to abbreviated new drug application, or ANDA, strategies. They attempt to define therapeutic equivalence through steady-state Cmax and AUC ranges relative to immediate-release topiramate administered twice daily.

What is the technical scope of the particle-size limitation?

The claimed micronized particle range is 1 to 1,000 micrometers. That is a wide range and includes many conventional pharmaceutical particle populations.

The limitation has two practical consequences:

1. A generic developer using topiramate particles outside the claimed range could pursue a non-infringement position.
2. A product using particles within the range may satisfy the limitation even if the average particle size differs from the branded product, unless the claim or prosecution history imposes a narrower interpretation.

The claim does not specify whether the range applies to D10, D50, D90, mean diameter or another particle-size statistic. That issue can become material in litigation. Particle-size testing methodology, sampling and batch records would be relevant to infringement analysis.

What is the role of the XR coating?

The coating is a mandatory limitation in the formulation claims. The coating must be selected from cellulosic polymers or acrylic polymers.

The claims therefore focus on reservoir-type or multiparticulate delivery systems rather than topiramate merely incorporated into any sustained-release dosage form. Beads, pellets or spheres carrying a topiramate-containing layer and a rate-controlling coating are within the principal technical concept.

A formulation that controls release solely through a hydrophilic matrix may avoid the literal coating limitation if it does not contain a qualifying cellulosic or acrylic polymer coating. The doctrine of equivalents could still be relevant, but the scope would depend on prosecution history and the technical differences between the products.

What are the method-of-use claims?

Claims 14 and 17 cover oral treatment of a broad group of neurological and psychiatric conditions. Claims 15, 16, 18 and 19 narrow the indication to epilepsy or migraine.

Independent claim	Treatment profile	Expressly narrowed indications
14	XR Tmax of 4-8.5 hours	Claim 15: epilepsy; claim 16: migraine
17	XR Tmax of at least 16 hours	Claim 18: epilepsy; claim 19: migraine

The listed conditions extend beyond approved topiramate indications and include bipolar disorder, anxiety, schizophrenia, ADHD, addiction, autism, ALS, neuropathic pain and other disorders. Claim breadth does not establish FDA approval for those uses.

For ANDA litigation, the practical importance of the method claims depends on the proposed labeling, prescribing behavior and whether the generic product’s label includes the patented treatment use. Formulation claims generally present a more direct infringement theory than broad method claims when the product itself is designed to match the patented release system.

What is the FDA and Orange Book status of the patent?

Trokendi XR is an FDA-approved extended-release capsule containing topiramate. The product is approved for certain epilepsy indications and migraine prevention. Trokendi XR is administered once daily and is available in capsule strengths including 25 mg, 50 mg, 100 mg and 200 mg. The product label describes extended-release delivery and capsule administration, including swallowing the capsule whole in the approved dosage instructions. [U.S. Food and Drug Administration, 2024]

US Patent 9,622,983 is part of the patent estate associated with extended-release topiramate products. Orange Book listing status must be assessed against the FDA’s current Approved Drug Products with Therapeutic Equivalence Evaluations database and the specific NDA record. The patent claims alone do not establish whether a patent is currently listed, delisted, expired, or subject to a regulatory certification.

Regulatory issue	Relevance to US 9,622,983
NDA	Trokendi XR, NDA 204635
Regulatory pathway	New drug application
Orange Book relevance	Determines whether an ANDA applicant must certify to the patent
Paragraph IV relevance	Applies if an applicant asserts that a listed patent is invalid, unenforceable or not infringed
Label-based risk	Highest where the proposed label includes patented epilepsy or migraine use
Product-by-process risk	The claims are primarily formulation and PK claims, not manufacturing-process claims

The FDA does not determine patent validity or infringement. The agency’s role is to administer the regulatory certification and approval framework under the Hatch-Waxman Act. [FDA, 2003]

When does US Patent 9,622,983 lose exclusivity?

The patent issued April 18, 2017. Public patent records identify June 12, 2029 as the expected expiration date associated with the core extended-release topiramate patent family, subject to any applicable patent-term adjustment, terminal disclaimer, patent-term extension or other record-specific modification. [U.S. Patent and Trademark Office, 2017]

Milestone	Date
Earliest reported family priority date	June 12, 2009
Patent issue date	April 18, 2017
Expected family expiration	June 12, 2029
Earliest routine post-expiration generic entry	Potentially June 13, 2029, absent other blocking rights

Expiration of US 9,622,983 would not necessarily eliminate all barriers to generic entry. Other Orange Book-listed patents, non-listed formulation patents, regulatory exclusivity, pediatric exclusivity, or litigation settlements could affect launch timing.

How many patents cover the Trokendi XR patent estate?

The extended-release topiramate estate includes multiple US patents and continuation applications directed to formulations, release profiles and related product characteristics. Publicly associated patents include US 8,673,378, US 8,871,778, US 9,622,983, US 9,763,851, US 10,292,912 and US 10,413,570. The precise active Orange Book set must be confirmed against the current FDA listing.

Patent	General relevance
US 8,673,378	Extended-release topiramate formulation claims
US 8,871,778	Related sustained-release formulation claims
US 9,622,983	Coated XR formulation, optional IR component, PK-defined claims
US 9,763,851	Related extended-release topiramate claims
US 10,292,912	Later formulation or continuation claim set
US 10,413,570	Additional related patent rights

Continuation practice can produce overlapping but materially different claim scope. A challenger must analyze each patent separately. Invalidating US 9,622,983 would not automatically invalidate the other patents.

Which companies challenge extended-release topiramate patents?

Generic competition exists for immediate-release topiramate products, including generic tablets, capsules and oral solutions. Extended-release competition is more concentrated because the branded products depend on multiparticulate formulation technology, bioequivalence testing and patent certifications.

Potential ANDA challengers may include large generic manufacturers and specialty-generic companies with topiramate capabilities. A company’s filing of an ANDA does not establish a Paragraph IV challenge, and a Paragraph IV certification does not establish commercial launch.

The principal competitive products include:

Product	Active ingredient	Release type	Commercial relevance
Trokendi XR	Topiramate	Extended release	Supernus branded once-daily capsule
Qudexy XR	Topiramate	Extended release	Competing extended-release capsule and sprinkle product
Topamax	Topiramate	Immediate release	Original branded product
Generic topiramate	Topiramate	Immediate release	Broad generic competition
Oxtellar XR	Oxcarbazepine	Extended release	Competes in epilepsy but is not a topiramate product

Qudexy XR is the closest formulation competitor because it also uses extended-release topiramate and sprinkle-oriented delivery. Its formulation, patents and regulatory record require separate analysis. Similar therapeutic use does not establish infringement of US 9,622,983.

What Paragraph IV risks exist for a generic topiramate product?

A generic applicant seeking approval before patent expiry would generally evaluate four Hatch-Waxman certification options:

1. Paragraph I: no patent information has been submitted.
2. Paragraph II: the patent has expired.
3. Paragraph III: the applicant will wait until patent expiration.
4. Paragraph IV: the patent is invalid, unenforceable or will not be infringed.

A Paragraph IV strategy against US 9,622,983 would likely focus on:

• Failure to meet the claimed in vivo Tmax range.
• Absence of a cellulosic or acrylic polymer coating.
• Particle sizes outside the claimed range.
• Lack of an IR component where a dependent claim is asserted.
• Failure to satisfy the claimed Cmax or AUC ranges.
• Obviousness based on known coated-bead topiramate formulations and conventional excipients.
• Written-description or enablement challenges to the extensive excipient and polymer lists.
• Indefiniteness arguments concerning “immediately and continuously,” “micronized particles,” and the measurement of the claimed pharmacokinetic parameters.

The most commercially effective design-around is likely a formulation that avoids the claimed coating architecture or produces a clearly different XR Tmax profile. A design-around based only on excipient substitution may be weak because the independent claims cover broad polymer and excipient classes.

How strong is the patent estate?

US 9,622,983 has moderate-to-strong commercial relevance because it combines structural and functional limitations. The structural requirements identify a recognizable delivery system, while the PK limitations can be used to distinguish the branded product from generic formulations.

Strength factor	Assessment
Product relevance	High for Trokendi XR-like products
Claim breadth	Broad across polymers, excipients and doses
Structural specificity	Moderate; coated XR component is required
PK specificity	High; Tmax and steady-state exposure are expressly claimed
Design-around potential	Moderate
Invalidity exposure	Moderate, particularly for obviousness and functional-claim issues
Manufacturing barrier	Moderate; multiparticulate coating and PK optimization require development capability
Litigation leverage	Meaningful if the patent is Orange Book-listed and the proposed product matches Trokendi XR

The patent is stronger against a copycat multiparticulate product than against a matrix tablet or a formulation intentionally engineered to produce a nonclaimed Tmax.

What manufacturing and IP barriers affect generic entry?

The key technical barrier is reproducible control of release kinetics. A generic manufacturer must manage:

• Topiramate particle-size distribution.
• Drug loading on beads or inert carriers.
• Coating uniformity.
• Polymer grade and viscosity.
• Pore-former concentration.
• Immediate-release and extended-release population ratios.
• Dissolution across pH conditions.
• Single-dose and steady-state PK.
• Capsule and sprinkle performance.

Claims 4, 5 and 8 increase coverage around conventional formulation components. They do not independently require a particular manufacturing method, but they may capture common process configurations used to produce coated beads.

A generic product can meet bioequivalence requirements while avoiding a patent claim, but bioequivalence does not itself establish non-infringement. The PK ranges in claims 10 and 11 create a potential overlap zone between regulatory requirements and patent enforcement.

What litigation and settlement issues matter?

A Paragraph IV filing involving a listed patent can trigger patent litigation under 35 U.S.C. §271(e)(2). The filing of an infringement action within the statutory period can create a regulatory stay of ANDA approval, generally subject to the Hatch-Waxman framework.

Relevant litigation questions include:

• Whether US 9,622,983 was listed for the relevant NDA.
• Whether an ANDA applicant certified Paragraph IV to the patent.
• Whether the patent owner sued within the statutory period.
• Whether the case ended in settlement, judgment, dismissal or claim construction.
• Whether a settlement permits an earlier launch date.
• Whether other Trokendi XR patents remain enforceable after resolution of this patent.

Settlement agreements may include licensed launch dates, authorized-generic provisions, payment terms, or restrictions on formulation changes. A settlement involving one patent does not necessarily resolve the entire patent estate.

Key Takeaways

• US 9,622,983 targets coated, sustained-release topiramate formulations rather than topiramate generally.
• Claims 1 and 14 require an XR Tmax of 4 to 8.5 hours.
• Claims 13 and 17 require an XR Tmax of at least 16 hours.
• Micronized topiramate, a cellulosic or acrylic coating, and immediate-and-continuous release are central limitations.
• Beads, capsules, sprinkles, binders, pore formers and inert carriers are covered through dependent claims.
• Claims 10 and 11 add steady-state Cmax and AUC ranges relative to twice-daily immediate-release topiramate.
• The expected family expiration date is June 12, 2029, subject to the official patent record.
• Trokendi XR is the primary commercial product associated with the patent estate.
• The principal generic risk is a Paragraph IV challenge supported by PK-based non-infringement and obviousness arguments.
• Other extended-release topiramate patents may remain relevant even if US 9,622,983 is invalidated or expires.

FAQs

Is US 9,622,983 a patent on Trokendi XR?

It is associated with the extended-release topiramate technology used in Trokendi XR, but the patent does not claim the brand name. It claims specified formulations and treatment methods.

Does the patent cover generic immediate-release topiramate?

Generally, no. The claims require a sustained-release formulation with an extended-release component and a qualifying polymer coating.

Can a generic use hydroxypropylmethylcellulose without infringing?

Not necessarily. Hydroxypropylmethylcellulose is expressly identified as a qualifying coating material in dependent claims and appears in several listed formulation categories. Its use would require a complete claim-by-claim analysis.

Does a 4-to-8.5-hour Tmax automatically establish infringement?

No. The product must satisfy every limitation of the relevant claim, including the particle-size, release, coating and formulation requirements. The Tmax result would be one element of the analysis.

Can a sprinkle formulation avoid US 9,622,983?

A sprinkle product is expressly covered by claims 6 and 24 when the independent claim limitations are met. The dosage form alone does not create a safe harbor.

References

1. U.S. Food and Drug Administration. (2003). Guidance for industry: 180-day exclusivity when multiple ANDAs are submitted on the same day. FDA.

2. U.S. Food and Drug Administration. (2024). Trokendi XR (topiramate) extended-release capsules: Prescribing information. FDA.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA, Center for Drug Evaluation and Research.

4. U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,622,983: Sustained release topiramate formulations. USPTO.

5. U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term information. USPTO.

Drugs Protected by US Patent 9,622,983

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-001	Aug 16, 2013	AB1	RX	Yes	No			Y			USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-001	Aug 16, 2013	AB1	RX	Yes	No			Y			USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-002	Aug 16, 2013	AB1	RX	Yes	No			Y			USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-002	Aug 16, 2013	AB1	RX	Yes	No			Y			USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
Supernus Pharms	TROKENDI XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	201635-003	Aug 16, 2013	AB1	RX	Yes	No			Y			USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE

International Family Members for US Patent 9,622,983

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007319141
Canada	2618240
Germany	07870164
European Patent Office	1973528
European Patent Office	2394643