DEXILANT SOLUTAB Drug Patent Profile

When do Dexilant Solutab patents expire, and when can generic versions of Dexilant Solutab launch?

Dexilant Solutab is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are five patents protecting this drug.

This drug has fifty patent family members in twenty-seven countries.

The generic ingredient in DEXILANT SOLUTAB is dexlansoprazole. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dexilant Solutab

A generic version of DEXILANT SOLUTAB was approved as dexlansoprazole by PH HEALTH on April 19^th, 2017.

Summary for DEXILANT SOLUTAB

International Patents:	50
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	62
Patent Applications:	952
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXILANT SOLUTAB
DailyMed Link:	DEXILANT SOLUTAB at DailyMed

US Patents and Regulatory Information for DEXILANT SOLUTAB

DEXILANT SOLUTAB is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	9,238,029		Y
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	8,461,187*PED				Y
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	9,011,926		Y
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	9,241,910		Y
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016		DISCN	Yes	No	8,871,273*PED				Y

Expired US Patents for DEXILANT SOLUTAB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	9,011,926
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	9,238,029
Takeda Pharms Usa	DEXILANT SOLUTAB	dexlansoprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	208056-001	Jan 26, 2016	9,145,389

International Patents for DEXILANT SOLUTAB

See the table below for patents covering DEXILANT SOLUTAB around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	348601
Australia	3731699
Canada	2323680	COMPRIMES SE DESINTEGRANT DANS LA BOUCHE (ORALLY DISINTEGRABLE TABLETS)
Canada	2587022
China	1195500
China	1311669

Supplementary Protection Certificates for DEXILANT SOLUTAB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1129088	PA2014014	Lithuania		PRODUCT NAME: DEXLANSOPRAZOLUM; REGISTRATION NO/DATE: LT/1/13/3415/001 - LT/1/13/3415/004, 2013 10 31 LT/1/13/3416/001 - LT/1/13/3416/004 20131031
1129088	PA2014014,C1129088	Lithuania		PRODUCT NAME: DEXLANSOPRAZOLUM; REGISTRATION NO/DATE: LT/1/13/3415/001 - LT/1/13/3415/004, 2013 10 31 LT/1/13/3416/001 - LT/1/13/3416/004 20131031
1129088	2014/008	Ireland		PRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919
1129088	C01129088/01	Switzerland		PRODUCT NAME: DEXLANSOPARAZOL; REGISTRATION NO/DATE: SWISSMEDIC 62993 09.05.2014
1129088	1490004-7	Sweden		PRODUCT NAME: DEXLANSOPRAZOL; REG. NO/DATE: 47912, 47913, 47914 20130919
1129088	122014000036	Germany		PRODUCT NAME: KRISTALLINE FORM DES (R)-2-(((3-METHYL-4-(2,2,2-TRIFLUORETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-1H-BENZIMIDAOLS; NAT. REGISTRATION NO/DATE: 87192.00.00 87193.00.00 87194.00.00 87195.00.00 20131118 FIRST REGISTRATION: SCHWEDEN 47911 47912 47913 47914 20130919

Last updated: June 20, 2026

DEXILANT SOLUTAB (dexlansoprazole) Market Dynamics, Financial Trajectory, and Competitive Patent/Generic Risk

Dexilant SoluTab (dexlansoprazole delayed-release orally disintegrating tablet) is a branded PPI positioned for GERD and erosive esophagitis. The market’s near- and mid-term trajectory is shaped by (1) broader class-level erosion from generic PPIs, (2) penetration dynamics versus other branded and OTC-available PPI regimens, and (3) the timing and strength of remaining exclusivity and patent coverage tied to the SoluTab dosage form and dexlansoprazole franchise.

Limiting factor for a complete, high-confidence financial trajectory: the request requires quantified revenue history, gross-to-net movement, share, and forecast by geography, which cannot be produced from the information available in this prompt.

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How big is the Dexilant SoluTab market and what is its revenue trajectory vs generic PPIs?

Featured snippet answer: Dexilant SoluTab operates in a mature proton pump inhibitor market where generic PPIs drive price compression. Without validated, source-backed figures, any exact revenue curve, market share, or forecast would be unsupported.

Market drivers that move Dexilant SoluTab sales

• Class substitution risk (generic PPIs): Clinicians and payers often default to lower-cost omeprazole/esomeprazole/lansoprazole equivalents, shrinking incremental demand for any single branded PPI unless a distinct clinical or dosing argument is compelling.
• Formulation-based retention: SoluTab’s differentiator is oral disintegration with a delayed-release architecture intended to support dexlansoprazole’s dual delayed release profile. In formularies, this can preserve a niche even when competing generic PPIs undercut price.
• Reimbursement and prior authorization: Access barriers are decisive. PPIs with preferred tier status displace branded options unless patient history supports continued branded therapy.
• Durability of GERD management demand: GERD is chronic, which stabilizes overall class volume. Branded share still erodes in cycles as payer policies adjust and generics expand.

Commercial performance metrics needed for a defensible trajectory (not provided)

To construct a Bloomberg-style financial trajectory, the following are typically required and must be sourced:

• Annual Net product sales (US, and where possible international) and gross-to-net
• Prescription share and TRx trends by channel
• ACE (average cost equivalents) and payer mix (commercial vs Medicaid/Medicare)
• Changes in copay offset programs and rebate structure
• Dose and indication mix (GERD vs erosive esophagitis)

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What patent estate protects Dexilant SoluTab and how strong is it vs generics?

Featured snippet answer: Patent protection analysis requires a specific Orange Book record for the SoluTab product and mapped unexpired protections for the active ingredient and the dosage form. That product-level dataset is not present in the prompt, so an accurate “how strong is it” assessment cannot be completed here.

How the patent risk usually breaks down for branded PPIs

For branded PPI tablets/ODTs, the remaining exclusivity and patent estate often falls into:

• Composition-of-matter or active ingredient process patents (generics risk)
• Formulation and dosage-form patents (ODT or specific film/disintegrating layer systems)
• Method-of-use patents tied to dosing schedules or patient subsets
• Polymorph/solid-state patents if relevant to the marketed solid form
• Orange Book exclusivity tied to new clinical investigations (if any)

Biosimilar risk

Not applicable: Dexlansoprazole is a small molecule.

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When does Dexilant SoluTab lose exclusivity and when are likely generic/ANDAs possible?

Featured snippet answer: A precise exclusivity and ANDA timing map depends on (1) Orange Book-listed expiration dates for the exact dosage form and strength and (2) any FDA exclusivity terms. Those dates are not supplied, so a timeline cannot be stated accurately.

What governs “entry timing” in the real world

• Orange Book expiration: earliest patent or exclusivity expiration that permits final approval for generic
• Statutory exclusivity: NCE or other exclusivity types (if applicable) can block approval even with patent expiry
• Paragraph IV litigation clocks: filing date and any stay periods can push approval

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What Orange Book status does Dexilant SoluTab have and which patents are listed?

Featured snippet answer: Orange Book status is product- and strength-specific. The prompt does not include the Orange Book listing data (submission numbers, patents, expiration dates, exclusivity codes), so a compliant, accurate list of patents cannot be produced.

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How does Dexilant SoluTab compare with other branded PPIs and generics on formulary access?

Featured snippet answer: In US formularies, Dexilant SoluTab competes in a heavily substitutable class where preferred-tier placement and PA criteria are the dominant determinants of branded persistence.

Competitive positioning typically used by branded PPIs

• Differentiated dosing narrative: dexlansoprazole’s delayed-release behavior is marketed as improving symptom control timing across the day.
• Patient adherence: SoluTab’s ODT format reduces friction for patients who have difficulty swallowing tablets.
• Therapy continuity: once a patient is stabilized on a branded PPI with documented benefit, switches are less likely unless payer policy forces substitution.

Generic pressure dynamics

• Early switch cohorts: new starts are often more likely to be routed to generics if the plan covers them with lower cost sharing.
• Later switch cohorts: long-term patients are switched when rebate pressure and tier changes occur, often after payer contracts renew.

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What Paragraph IV challenges and patent litigation affect Dexilant SoluTab?

Featured snippet answer: Litigation and Paragraph IV activity must be tied to specific Orange Book patents and FDA ANDA status for Dexilant SoluTab. No product-specific litigation docket data is included in the prompt.

What to track for litigation-driven market impact

• ANDA filer(s) and Paragraph IV basis
• Stipulation and settlement terms (often includes agreed launch dates or non-final approval terms)
• Court rulings affecting claims construction or validity

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What settlements drive branded-to-generic transitions for Dexilant SoluTab?

Featured snippet answer: Settlement agreements must be identified by party, patent list, and any agreed triggers (including launch dates). Settlement data is not present in the prompt, so a definitive transition analysis cannot be produced.

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What formulations are protected for Dexilant SoluTab and what are the generic design-around barriers?

Featured snippet answer: Without the formulation patent set and their claim scope, it is not possible to state which features are protected and what generic design-around strategies are plausible.

Common design-around vectors for ODT PPIs

• Different disintegrating agents or matrix compositions
• Alternative tablet geometry and manufacturing methods
• Different release microstructures that still meet bioequivalence but avoid infringement

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How does FDA regulatory status (ANDA/505(b)(2) pathways) shape Dexilant SoluTab market risk?

Featured snippet answer: Regulatory risk is driven by whether generics can secure approval under ANDA and whether the relevant patents block final approval. The prompt provides no FDA submission record for Dexilant SoluTab, so the pathway analysis cannot be completed.

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Commercial outlook: what financial trajectory should investors expect for Dexilant SoluTab?

Featured snippet answer: A credible financial outlook requires validated historical revenue and an exclusivity/patent-and-entry scenario tied to the exact dosage form. Those inputs are not available in the prompt.

What investors typically model for mature branded PPIs

• Base decline from class erosion: branded share declines as generics gain coverage breadth and formulary preference
• Branded resilience premium: if dexlansoprazole retains niche access via ODT and clinical differentiation, decline may be slower than other branded PPIs
• Entry shock: if a generic can launch at the earliest eligible date, there is often a sharp TRx and sales step-down

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Key Takeaways

• Dexilant SoluTab sits in a mature PPI market where generic substitution is the dominant long-run demand driver.
• The decisive determinants of Dexilant SoluTab’s financial trajectory are payer access, product-specific differentiation (ODT format and dexlansoprazole dosing profile), and the remaining exclusivity/patent calendar tied to the marketed dosage form.
• A defensible revenue trajectory, generic entry timing, and patent strength assessment require Orange Book product data and validated financial statements, which are not included in the prompt.

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FAQs

1. What differentiates Dexilant SoluTab from standard dexlansoprazole capsules in payer coverage?
2. How do prior authorization requirements typically impact branded PPI persistence vs generics?
3. What patent categories most often delay generic entry for orally disintegrating solid-dose PPIs?
4. How does gross-to-net change for branded PPIs as generic competition increases?
5. What launch sequencing patterns do settlements usually create for ANDA entry into branded PPI portfolios?

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References (APA)

No sources were provided in the prompt to cite.