DEXILANT Drug Patent Profile

Which patents cover Dexilant, and what generic alternatives are available?

Dexilant is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty patent family members in thirty-one countries.

The generic ingredient in DEXILANT 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

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

Summary for DEXILANT

International Patents:	120
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	31
Patent Applications:	952
Drug Prices:	Drug price information for DEXILANT
Drug Sales Revenues:	Drug sales revenues for DEXILANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXILANT
What excipients (inactive ingredients) are in DEXILANT?	DEXILANT excipients list
DailyMed Link:	DEXILANT at DailyMed

See drug prices for DEXILANT

See drug sales revenues for DEXILANT

Recent Clinical Trials for DEXILANT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Karachi	Phase 1
SAMI Pharmaceutical, Karachi Pakistan	Phase 1
Taipei Veterans General Hospital, Taiwan	N/A

See all DEXILANT clinical trials

Pharmacology for DEXILANT

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Paragraph IV (Patent) Challenges for DEXILANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DEXILANT	Delayed-release Capsules	dexlansoprazole	30 mg	022287	1	2010-11-30

US Patents and Regulatory Information for DEXILANT

DEXILANT is protected by eight 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	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	9,233,103
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	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	8,173,158*PED				Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	AB	RX	Yes	No	9,011,926		Y
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes	8,871,273		Y

Expired US Patents for DEXILANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	9,145,389
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	9,238,029
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	9,011,926
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-001	Jan 30, 2009	9,238,029
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	9,011,926

International Patents for DEXILANT

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	61202
Canada	1327010	COMPOSITIONS PHARMACEUTIQUES CONTENANT UN COMPOSE ANTI-ULCEREUX DE TYPE BENZIMIDAZOLE ET SA PRODUCTION (STABILIZED SOLID PHARMACEUTICAL COMPOSITION CONTAINING ANTIULCER BENZIMIDAZOLE COMPOUND AND ITS PRODUCTION)
Canada	1338377	COMPOSITION PHARMACEUTIQUE STABILISEE ET SA PREPARATION (STABILIZED PHARMACEUTICAL COMPOSITION AND ITS PRODUCTION)
Canada	1338399	COMPOSITION PHARMACEUTIQUE STABILISEE ET SA PREPARATION (STABILIZED PHARMACEUTICAL COMPOSITION AND ITS PRODUCTION)
Germany	3750431

Supplementary Protection Certificates for DEXILANT

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

DEXILANT (dexlansoprazole delayed-release): Market Dynamics and Financial Trajectory

Last updated: July 7, 2026

DEXILANT is a branded proton pump inhibitor (PPI) with a revenue profile driven by ulcerative indications, payer contracting, and channel shifts from commercial to Medicare Part D. After generic entry pressure in the broader PPI class, DEXILANT’s financial trajectory has depended on (1) label breadth across erosive esophagitis and maintenance, (2) formulary position versus omeprazole/esomeprazole/pantoprazole, and (3) the continued performance of the dual release platform (DEXILANT MR dosing) relative to older PPIs on convenience and persistence in real-world use.

How has DEXILANT performed commercially since launch and what is the revenue trajectory?

What do trend lines show for DEXILANT sales after generic PPI competition intensified?

DEXILANT’s sales trajectory follows the typical branded PPI curve: steady growth into maturity, then flattening and decline as generics gained share across the class. The key differentiator for revenue maintenance is not therapeutic superiority but formulary and switching behavior in managed care.

Which factors most influence DEXILANT revenue performance each year?

1. Payer coverage and step therapy: PPIs are a mature therapeutic class with extensive generic penetration. DEXILANT’s performance is highly correlated to rebate rates, preferred formulary status, and restrictions that steer patients to lower-cost alternatives.
2. Channel mix: Retail and specialty pharmacy mix in GI drugs affects net sales through different discount structures and distribution costs. DEXILANT is primarily a retail GI product, so retail contracting is central.
3. Dose and regimen adherence: DEXILANT’s dual delayed-release dosing supports once-daily adherence, which can improve persistence compared with off-formulary switching. This can partially offset class-level price pressure.
4. Indication targeting: Revenue is tied to erosive esophagitis and maintenance therapy volumes, which are sensitive to guideline adherence and diagnostic rates.

What is DEXILANT’s exposure to “class” pricing and substitution?

DEXILANT faces rapid substitution to generic omeprazole/esomeprazole/pantoprazole wherever formulary rules allow. Even when DEXILANT remains preferred, plan changes can reduce utilization through step edits.

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What market dynamics shape PPI category growth and DEXILANT share?

Is the PPI market shrinking or expanding, and how does that affect DEXILANT?

The PPI market is largely mature. Growth is driven by demographic aging, GERD prevalence, and new diagnosis rates, while price erosion from generics and payer-led contracting compresses value.

What buyer-side dynamics matter most for PPIs like DEXILANT?

1. Formulary tiering and rebate strategy
   • Plans use tier placement and prior authorization to route to generics.
   • Branded PPIs maintain volume by negotiating net price and demonstrating clinical and adherence value.
2. National and regional contracting
   • GI drugs are subject to multi-year contracting with renewal points that can shift share quickly.
3. Pharmacy benefit design
   • Differential copays, step therapy, and quantity limits determine which PPIs patients can access without switching.

How do patient-level factors influence DEXILANT switching risk?

• Patients stable on a branded PPI may remain on it if it is low-cost at the point of sale.
• High out-of-pocket costs increase discontinuation risk and switching to generics mid-therapy.

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What competitive landscape pressures DEXILANT, and who are the main substitutes?

Which drugs compete directly with DEXILANT in GERD and erosive esophagitis?

DEXILANT’s principal substitutes are other PPIs, especially generic versions:

• omeprazole (including omeprazole delayed-release)
• esomeprazole
• pantoprazole
• lansoprazole
• rabeprazole
  Competition is primarily price and coverage driven, not new molecular mechanism differentiation.

How does DEXILANT compare against older PPIs on practical value?

DEXILANT’s economic position depends on real-world outcomes in persistence, symptom control, and tolerance relative to generic PPIs in payer-constrained environments. In most markets, the class’s clinical efficacy is broadly comparable, so formulary access is the main determinant of branded persistence.

What role do non-PPI GERD therapies play?

Histamine-2 receptor antagonists (H2 blockers), alginate therapies, and newer GERD adjuncts can influence segment share at the margins, but DEXILANT’s revenue is still mainly linked to PPI channel utilization.

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How does DEXILANT’s dosing platform influence payer and prescriber behavior?

Does DEXILANT’s delayed-release and dual release profile reduce switching?

The dual delayed-release design can support symptom coverage across a 24-hour period, which may reduce breakthrough symptoms that drive re-prescribing and prior authorizations. That operational advantage can improve adherence in patient groups that are sensitive to nighttime or morning symptoms.

What does that mean for net sales volatility?

• If a plan restricts branded PPIs, switching risk rises quickly.
• If DEXILANT remains accessible without frequent authorization triggers, volume tends to be more stable even as pricing erodes.

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What pricing and reimbursement dynamics govern DEXILANT net sales?

How does net price typically change for branded PPIs under generic threat?

Net price compresses through rebates and contracting concessions. Even if gross price remains, net realization declines when:

• formulary access is narrowed,
• rebate demands increase,
• utilization is pressured to generics.

What drives DEXILANT’s gross-to-net gap?

• payer mix changes
• evolving rebate structures
• chargebacks and wholesaler discounts
• pharmacy benefit administration fees

What is the implication for margin and cash flow?

Margin is pressured by contracting economics, while brand marketing spend and medical affairs budgets typically persist at a level required to sustain share. Financial trajectory therefore reflects both topline volume and net price effectiveness.

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What does DEXILANT’s financial trajectory imply for future market positioning?

What is the likely path under continued PPI generic dominance?

DEXILANT’s future value is most likely to be shaped by:

• maintaining a defendable formulary position in select accounts,
• using payer-friendly evidence narratives tied to adherence and symptom control,
• sustaining a durable base of persistent patients.

What are the “peak-to-decline” levers for DEXILANT-style brands?

• timing of generic substitution at the PBM level
• intensity of step therapy and prior authorization enforcement
• ability to stay in preferred tiers and limit prior auth denials

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How do manufacturing and supply dynamics affect DEXILANT performance?

Brand PPIs can experience volatility from:

• packaging/labeling changes required for updates
• distribution optimization tied to wholesaler and PBM demand forecasts
• mitigation of supply constraints that can temporarily disrupt fill rates

Supply disruption would show up as volume shortfalls and could increase short-term promotional spend to regain share, impacting net sales and earnings quality.

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What regulatory and lifecycle items can alter DEXILANT’s market outlook?

Does DEXILANT face ongoing exclusivity and label expansion that support commercial value?

DEXILANT’s long-term commercial value is tied to its approved label and how quickly generic products dominate the active ingredient market. Any new formulation, new dosage strengths, or updated labeling that broadens use can extend revenue life, but in mature PPIs, the binding constraints are payer preferences and generic competition.

How do FDA labeling and post-marketing data influence formularies?

Plan formularies react to:

• updated safety communications
• comparative effectiveness narratives in managed care dossiers
• real-world evidence on adherence and outcomes

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What patent estate and generic entry risks should be assumed for DEXILANT?

DEXILANT’s market dynamics are shaped by active ingredient patent expiry and generic competition. Under standard PPI lifecycle patterns, once generic access is achieved at scale, branded revenue is driven less by residual exclusivity and more by contracting leverage.

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Key Takeaways

• DEXILANT operates in a mature PPI market where revenue is driven primarily by formulary access, net contracting economics, and persistence rather than by ongoing molecular differentiation.
• The financial trajectory has been shaped by generic substitution and payer-led step therapy, with the dual delayed-release dosing supporting adherence-based share stability when access is protected.
• Net sales performance is most sensitive to rebate and coverage dynamics that determine how often patients are forced to switch to lower-cost PPIs.
• Future market positioning will depend on maintaining preferred coverage in high-value segments and minimizing authorization barriers that accelerate switching to generics.

FAQs

1. How does DEXILANT’s formulary status differ across commercial vs Medicare Part D plans?
2. What rebate and gross-to-net pressures typically accelerate branded PPI decline after generic expansion?
3. What metrics best track DEXILANT performance: TRx, persistence, adherence, or net price realization?
4. How do prior authorization and step therapy rules change switching rates from DEXILANT to generics?
5. What GI subpopulations (erosive vs non-erosive GERD) drive the most sensitivity to payer restrictions for DEXILANT?

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drug databases: Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data
3. FDA. (n.d.). Labeling for dexlansoprazole products. https://www.accessdata.fda.gov/scripts/cder/daf/
4. IQVIA. (n.d.). National and regional prescription sales analytics (industry reports). https://www.iqvia.com/solutions/commercialization/market-access-and-analytics

DrugChatter Q&A for DEXILANT

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