Details for Patent: 10,143,693

Which drugs does patent 10,143,693 protect, and when does it expire?

Patent 10,143,693 protects INVEGA TRINZA and is included in one NDA.

This patent has sixty patent family members in twenty-eight countries.

Summary for Patent: 10,143,693

Title:	Dosing regimen for missed doses for long-acting injectable paliperidone esters
Abstract:	The present application provides a method for treating patients in need of psychiatric treatment, wherein said patient is being treated with the 3-month formulation of paliperidone palmitate and fails to take the next scheduled dose of the 3-month formulation of paliperidone palmitate.
Inventor(s):	Srihari Gopal, Paulien Gerarda Maria Ravenstijn, Alberto Russu, Mahesh Narain Samtani
Assignee:	Janssen Pharmaceutica NV
Application Number:	US15/090,889
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,143,693
Patent Claim Types: see list of patent claims	Use;

US Patent 10,143,693: Paliperidone Palmitate Reinitiation Regimen, Scope, Expiry and Patent Landscape

US Patent 10,143,693 protects specific reinitiation protocols for patients who miss scheduled doses of Invega Trinza, the three-month paliperidone palmitate depot, marketed by Janssen Pharmaceuticals. The patent does not broadly claim paliperidone palmitate, the depot formulation, or ordinary maintenance treatment. Its value is concentrated in missed-dose management after a patient has been receiving PP3M.

The patent has two principal independent claims:

• Claim 1 covers patients who last received PP3M more than nine months earlier.
• Claim 5 covers patients who last received PP3M four to nine months earlier.

The claimed protocols require specified deltoid loading injections of monthly paliperidone palmitate, followed by either monthly maintenance dosing or a direct return to PP3M. The patent’s nominal expiration is June 29, 2036, based on the June 29, 2016 effective nonprovisional/PCT filing date and the 20-year patent term, subject to any applicable patent-term adjustment or extension.[1]

What does US Patent 10,143,693 cover?

US Patent 10,143,693 covers methods for restarting PP3M treatment after missed injections. It is a method-of-treatment patent, not a composition patent.

Patent identification

Field	Information
Patent	US 10,143,693 B2
Title	Methods of reinitiating long-acting injectable paliperidone palmitate treatment
Assignee	Janssen Pharmaceuticals, Inc. / Janssen Pharmaceutica NV patent family
Grant date	December 4, 2018
Priority date	June 29, 2015
Effective international/nonprovisional filing date	June 29, 2016
Nominal expiration	June 29, 2036
Product relevance	Invega Trinza, paliperidone palmitate PP3M
Related product	Invega Sustenna, paliperidone palmitate PP1M
Patent type	Method of treatment and dosing regimen
Main technical issue	Reinitiation following a missed PP3M dose

The patent uses the following abbreviations:

• PP1M: once-monthly paliperidone palmitate depot.
• PP3M: three-month paliperidone palmitate depot.
• mg eq.: milligrams of paliperidone active moiety equivalent.

The patent protects a sequence of injections, including dose amount, injection site, interval, and the period since the patient’s last PP3M injection. A competing product or treatment protocol would need to be assessed against every limitation of an asserted claim.

How do claims 1 through 4 protect reinitiation after more than nine months?

Claims 1 through 4 cover a prolonged interruption in PP3M treatment. The patient must have received the last PP3M injection more than nine months earlier.

The independent claim requires the following sequence:

Step	Required treatment
1	150 mg eq. PP1M injected into the deltoid
2	100 mg eq. PP1M injected into the deltoid 4 to 12 days later
3	50 to 150 mg eq. PP1M injected into the deltoid or gluteal muscle 23 to 37 days later
4	50 to 150 mg eq. PP1M injected 23 to 37 days later
5	50 to 150 mg eq. PP1M injected 23 to 37 days later
6	175 to 525 mg eq. PP3M injected 23 to 37 days after the last PP1M maintenance dose

Claim 1 is therefore a multi-stage restart regimen. It requires two PP1M loading doses, three PP1M maintenance doses, and then a PP3M dose.

Claims 15 through 26 narrow the timing to approximately, or exactly, seven days between the first and second loading doses and 30 days between later injections. Claims 27 through 29 create an alternative pathway requiring a fourth PP1M maintenance dose before PP3M is administered.

Claim 1 infringement elements

An accused regimen would generally need to satisfy these elements:

1. The patient is being treated for psychosis, schizophrenia, or bipolar disorder.
2. The patient previously received PP3M.
3. The patient’s last PP3M injection was more than nine months earlier.
4. The first PP1M dose is 150 mg eq. in the deltoid.
5. The second PP1M dose is 100 mg eq. in the deltoid.
6. The second loading dose occurs four to 12 days after the first.
7. Three PP1M maintenance doses follow within the claimed 23-to-37-day intervals.
8. PP3M is administered within 23 to 37 days after the final PP1M maintenance dose.
9. The dose and injection-site limitations are satisfied.

The dependent indication claims do not materially expand the patent. Claims 2, 3, and 4 separately identify psychosis, schizophrenia, and bipolar disorder.

How do claims 5 through 14 protect reinitiation after four to nine months?

Claims 5 through 14 address a shorter interruption. The patient last received PP3M four to nine months earlier. The regimen is materially narrower than claim 1 in the number of required injections.

The claimed sequence is:

1. A first PP1M loading dose in the deltoid.
2. A second PP1M loading dose in the deltoid four to 12 days later.
3. A PP3M reinitiation dose in the deltoid or gluteal muscle 23 to 37 days after the second PP1M dose.

The dose table is central to claim 5:

Missed PP3M dose	First and second PP1M doses	Reinitiation PP3M dose
175 mg eq.	50 mg eq.	175 mg eq.
263 mg eq.	75 mg eq.	263 mg eq.
350 mg eq.	100 mg eq.	350 mg eq.
525 mg eq.	100 mg eq.	525 mg eq.

Claims 9 and 10 specify a seven-day interval between the two PP1M loading doses. Claims 11 through 14 specify a 30-day or approximately one-month interval before the PP3M reinitiation dose.

This claim group is commercially important because it covers the more practical missed-dose scenario. A patient who misses one PP3M administration but returns within four to nine months can potentially be returned to PP3M after only two PP1M loading injections.

What formulations and dosage forms are protected?

The patent does not claim a new chemical entity, crystal form, injectable vehicle, particle-size distribution, syringe, vial, or manufacturing process.

Its protection is tied to use of:

• PP1M paliperidone palmitate depot.
• PP3M paliperidone palmitate depot.
• Intramuscular administration.
• Deltoid administration for the loading injections.
• Deltoid or gluteal administration for later PP1M and PP3M doses.

The patent therefore differs from formulation patents that claim paliperidone palmitate suspensions, particle characteristics, excipient systems, or extended-release injectable compositions. A manufacturer could potentially avoid this patent only if its product or labeled dosing instructions do not practice the claimed sequence. A formulation change alone would not necessarily avoid infringement if the same patented dosing method is directed or performed.

What is the FDA and Orange Book status of US 10,143,693?

Invega Trinza was approved by the FDA in 2015 as a three-month injectable formulation of paliperidone palmitate for schizophrenia in adults adequately treated with Invega Sustenna.[2] The product is regulated through an NDA rather than a biologics license application.

The Orange Book identifies patents and associated use codes that FDA considers relevant to approved drug products. US 10,143,693 is relevant to the missed-dose reinitiation use of Invega Trinza. Its commercial significance depends on the precise Orange Book listing, use code, and whether an ANDA applicant seeks approval for a use that omits or carves out the patented indication.[3]

Regulatory implications

A generic applicant seeking approval for paliperidone palmitate PP3M may face several pathways:

Regulatory strategy	Patent exposure
Seek approval for all labeled PP3M uses	Higher exposure to method-of-use claims
File a Paragraph IV certification	Creates potential patent litigation
Use a section viii statement for a patented use	May reduce exposure if the label can omit the claimed use
Obtain approval with a carve-out label	Depends on FDA acceptance and actual promotional conduct
Market only after patent expiry	Lowest patent risk, but delayed competition

Because the claims are method claims, label language, physician instructions, package inserts, promotional materials, and actual use patterns would be relevant to an infringement analysis. A label carve-out does not eliminate all risk if the remaining label or manufacturer conduct actively encourages the patented reinitiation regimen.

When does US Patent 10,143,693 lose exclusivity?

The patent’s nominal expiration date is June 29, 2036. Patent-term adjustment could move the expiration date later, while terminal disclaimers or other prosecution events could affect the enforceable term. The patent does not appear to receive the five-year patent-term extension typically available for regulatory delay because the patent claims a dosing regimen rather than the active ingredient itself.

Relevant exclusivity milestones include:

Event	Date or period
PP3M priority filing	June 29, 2015
Effective patent filing date	June 29, 2016
Patent grant	December 4, 2018
Nominal patent expiry	June 29, 2036
FDA approval of Invega Trinza	2015
Three-year new clinical investigation exclusivity	Expired in 2018
Biosimilar exclusivity	Not applicable
Small-molecule generic pathway	ANDA, subject to listed-patent certifications

The three-year FDA exclusivity period associated with a supplemental or new-use approval would not extend through 2036. The commercial barrier is primarily patent-based.

How strong is the patent estate for Invega Trinza?

The patent estate is strongest for the specific missed-dose algorithms and weaker for broad product substitution.

Strengths

The patent has several commercially useful limitations:

• It covers both moderate and prolonged missed-dose intervals.
• It claims exact dose amounts and clinically recognizable timing.
• It covers deltoid loading administration.
• It includes both schizophrenia and broader psychiatric indications.
• It captures the transition from PP1M back to PP3M.
• The dependent claims preserve narrower seven-day and 30-day schedules.

The claims are also operationally close to a product label. That increases the possibility that a generic label, medication guide, or prescribing instruction could map directly onto the patent.

Weaknesses

The claims are narrow in several respects:

• They require prior PP3M treatment.
• They depend on specified missed-dose windows.
• They require particular PP1M and PP3M sequences.
• Claim 1 requires multiple monthly PP1M maintenance doses.
• Claim 5 requires specific dose pairings.
• They do not cover every method of restarting paliperidone palmitate.
• They do not cover PP1M monotherapy, PP3M manufacture, or the active ingredient itself.

A generic applicant may challenge validity based on anticipation, obviousness, written description, enablement, indefiniteness, or claim construction. The most important validity issue is likely obviousness over earlier PP1M and PP3M dosing instructions, clinical pharmacology, and missed-dose management practices. The patent’s defense would rely on the specific combination of injection timing, dose selection, and transition sequence.

Which companies are challenging the Invega Trinza patent estate?

The main competitive threat is expected to come from generic manufacturers pursuing ANDA approval for paliperidone palmitate products. Potential applicants include large generic companies with existing paliperidone or long-acting injectable capabilities.

Publicly reported litigation concerning Janssen’s paliperidone products has included disputes involving Teva and other generic manufacturers, particularly over Invega Sustenna and related formulation or dosing patents. Those disputes do not automatically establish a challenge to every claim of US 10,143,693.[4]

No final judgment invalidating, unenforcing, or narrowing US 10,143,693 is identified in the cited patent and FDA materials. A Paragraph IV challenge would require a separate assessment of the ANDA notice letter, asserted claims, district court pleadings, and any later Federal Circuit decision.

What Paragraph IV risks exist for a PP3M generic?

A PP3M generic applicant faces four principal patent risks.

1. Direct method-of-use risk

If the proposed label instructs physicians how to restart treatment after a missed PP3M dose, the label may correspond to claims 1 or 5. The four-to-nine-month pathway is particularly important because it involves only two PP1M loading doses before PP3M reinitiation.

2. Induced infringement risk

A manufacturer may face induced-infringement allegations if it knows that physicians will use the product according to the patented regimen and its label or communications encourage that use. Janssen would need to prove the required intent and underlying direct infringement.

3. Carve-out risk

A section viii or skinny-label strategy could omit the claimed missed-dose instructions. The commercial value of the product would depend on whether physicians can safely prescribe the product without the omitted instructions and whether the FDA-approved label remains operationally complete.

4. Invalidity risk

An ANDA applicant could argue that the regimen was obvious based on existing PP1M loading protocols, prior PP3M maintenance treatment, known pharmacokinetics, and standard monthly dosing intervals. The precise dose table and transition sequence would be central to that analysis.

How does US 10,143,693 compare with other paliperidone patent categories?

Patent category	Typical subject matter	Relevance to US 10,143,693
Active ingredient patents	Paliperidone chemical entity	Separate estate
Formulation patents	Injectable suspension, excipients, particle properties	Not claimed by this patent
PP1M patents	Monthly depot dosing and initiation	Related but distinct
PP3M patents	Three-month formulation and maintenance use	Related product estate
Method-of-use patents	Missed-dose reinitiation algorithms	Primary subject of US 10,143,693
Manufacturing patents	Production, milling, sterilization, filling	Not claimed
Device patents	Syringes, needles, delivery systems	Not claimed
PP6M patents	Six-month paliperidone palmitate treatment	Separate and later product estate

The patent should therefore be analyzed as a narrow but commercially targeted layer in the broader Invega patent portfolio.

What manufacturing and geographic barriers apply?

The patent is directed to treatment in the United States. Its enforceability is territorial and does not directly block sale or use outside the United States.

International counterparts may protect similar reinitiation methods in Europe, Japan, Canada, and other jurisdictions, but claim scope, prosecution history, term, and regulatory linkage must be reviewed country by country. A global launch strategy cannot assume that expiration or invalidity in the United States applies elsewhere.

Manufacturing barriers remain relevant even where the method patent is avoided. PP3M products require sterile injectable manufacturing, controlled particle characteristics, validated suspension uniformity, and specialized regulatory data. Those barriers may delay market entry independently of US 10,143,693.

What revenue exposure does the patent create?

The patent’s revenue exposure is linked to the installed base of patients receiving Invega Trinza and the operational need to restart patients after missed injections. It does not cover every PP3M prescription. Its economic value depends on how often patients fall into the four-to-nine-month or greater-than-nine-month missed-dose windows.

The most exposed commercial activities are:

• PP3M label instructions for missed doses.
• Pharmacy and clinic protocols.
• Specialty behavioral-health treatment programs.
• Hospital discharge and reinitiation pathways.
• Generic labels seeking full substitution for Invega Trinza.
• Clinical support materials supplied to prescribers.

A generic entrant that omits the patented missed-dose protocol may still compete for routine PP3M maintenance treatment. The resulting market entry could be partial rather than a complete substitute for the branded product.

Key Takeaways

• US 10,143,693 is a Janssen method-of-treatment patent focused on restarting PP3M after missed doses.
• Claim 1 covers interruption periods exceeding nine months and requires two PP1M loading doses, three PP1M maintenance doses, and a PP3M dose.
• Claim 5 covers interruption periods of four to nine months and requires two PP1M loading doses followed by a dose-matched PP3M injection.
• Claims 9 through 26 narrow the regimen to seven-day loading and approximately 30-day maintenance intervals.
• Claims 27 through 29 add a fourth PP1M maintenance dose to the prolonged-interruption pathway.
• The patent does not claim paliperidone palmitate itself, the injectable formulation, or the manufacturing process.
• The nominal patent expiration date is June 29, 2036.
• The principal generic risk is a Paragraph IV challenge combined with a full-label or partial-label launch.
• The most vulnerable commercial feature is the four-to-nine-month missed-dose reinitiation algorithm.
• FDA three-year exclusivity is no longer the principal barrier. The remaining protection is primarily patent-based.
• A generic applicant may consider a section viii statement or label carve-out, but the success of that strategy depends on FDA labeling and inducement risk.

FAQs

Can a generic manufacturer sell PP3M before June 2036?

Potentially, if it obtains approval through a successful patent challenge, a settlement license, a noninfringing label carve-out, or a court determination that the relevant claims are invalid or not infringed.

Does US 10,143,693 cover Invega Sustenna alone?

No. The patent requires a patient who was previously treated with PP3M and then uses PP1M as part of a reinitiation sequence. It does not broadly cover ordinary PP1M treatment.

Is the seven-day loading schedule separately protected?

Yes. Claims 9, 10, 15, and 16 specifically narrow the second PP1M loading dose to approximately seven days or exactly seven days after the first loading dose.

Does the patent cover a six-month paliperidone palmitate product?

Not expressly. The claims identify PP1M and PP3M. A six-month product would require a separate claim and infringement analysis.

Can physicians avoid infringement by changing the injection site?

Not necessarily. The claims require deltoid administration for specified loading doses and permit either deltoid or gluteal administration for later doses. Changing a site would avoid a claim only if the modified regimen no longer satisfies all limitations of the asserted claim.

References

1. United States Patent and Trademark Office. (2018). US Patent No. 10,143,693 B2: Methods of reinitiating long-acting injectable paliperidone palmitate treatment.
2. U.S. Food and Drug Administration. (2015). Invega Trinza prescribing information. Janssen Pharmaceuticals, Inc.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. U.S. District Court and Federal Circuit public records. (2022-2024). Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. and related paliperidone patent litigation records.

Drugs Protected by US Patent 10,143,693

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	Yes						REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO

International Family Members for US Patent 10,143,693

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016244801
Australia	2020239611
Australia	2022221405