ACCOLATE Drug Patent Profile

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

Accolate is a drug marketed by Strides Pharma Intl and is included in one NDA.

The generic ingredient in ACCOLATE is zafirlukast. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Accolate

A generic version of ACCOLATE was approved as zafirlukast by DR REDDYS LABS LTD on November 18^th, 2010.

Summary for ACCOLATE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
Patent Applications:	5,807
Drug Prices:	Drug price information for ACCOLATE
What excipients (inactive ingredients) are in ACCOLATE?	ACCOLATE excipients list
DailyMed Link:	ACCOLATE at DailyMed

See drug prices for ACCOLATE

Recent Clinical Trials for ACCOLATE

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

Sponsor	Phase
Dana-Farber Cancer Institute	Phase 2
National Institutes of Health (NIH)	Phase 2
University of California, San Francisco	Phase 2

See all ACCOLATE clinical trials

Pharmacology for ACCOLATE

Drug Class	Leukotriene Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists

Paragraph IV (Patent) Challenges for ACCOLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACCOLATE	Tablets	zafirlukast	10 mg and 20 mg	020547	1	2008-02-29

US Patents and Regulatory Information for ACCOLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	AB	RX	Yes	No
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	AB	RX	Yes	Yes

Expired US Patents for ACCOLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996

International Patents for ACCOLATE

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

Country	Patent Number	Title	Estimated Expiration
Finland	83866
China	1243827
United Kingdom	9027014
Israel	78569	SUBSTITUTED CARBOXAMIDO-BENZ-HETEROCYCLYL-METHYL-BENZOIC ACIDS,PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM

Supplementary Protection Certificates for ACCOLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0199543	SPC/GB98/033	United Kingdom		PRODUCT NAME: ZAFIRLUKAST AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: IE PA 51/67/1 19960103; UK 12619/0108 19980605
0199543	97C0031	Belgium		PRODUCT NAME: ZAFIRLUKAST; NAT. REGISTRATION NO/DATE: 624 S 295 F 3 19961216; FIRST REGISTRATION: IE PA 51/67/1 19960103

ACCOLATE (nizatidine): Market dynamics and financial trajectory

Last updated: April 25, 2026

What is ACCOLATE’s commercial footprint?

ACCOLATE is the brand of nizatidine, an H2-receptor antagonist (H2RA) used for peptic ulcer disease and gastroesophageal reflux-related conditions. Its market is shaped by (1) long-cycle generic competition, (2) persistent preference for other acid-suppression classes in many formularies, and (3) narrow differentiation versus earlier-generation H2RAs and later-generation proton pump inhibitors (PPIs).

Key commercial dynamic: ACCOLATE operates in a segment with high price erosion once generics enter, and H2RA demand is typically substitution-prone to PPI-based care pathways where clinically appropriate.

How has generic competition changed ACCOLATE’s pricing power?

In mature H2RA brands, the dominant financial driver is loss of brand exclusivity and subsequent generic penetration. For ACCOLATE, the practical effect is consistent with the broader class pattern:

• Generic entry compresses net prices fast after the end of brand exclusivity.
• Formulary placement shifts toward lowest net cost unless there are specific patient-level tolerances or historical prescriber preferences.
• Gross-to-net tends to deteriorate due to rebates and contracting pressure as multiple generic SKUs compete.

Net effect: ACCOLATE’s financial trajectory is structurally biased toward declining revenue growth rates and lower profitability after generic saturation, with revenue largely sustained by residual utilization.

What are the likely market forces affecting volume and share?

For ACCOLATE’s H2RA indication set, the volume base is influenced by treatment selection norms:

1. PPI substitution in reflux and ulcer-related care

   • Many GI and GERD pathways favor PPIs due to stronger acid suppression.
   • H2RAs are still used in defined circumstances (e.g., specific intolerance patterns, step-down therapy, nocturnal breakthrough dosing contexts), which keeps demand from falling to zero.

2. Switching behavior under payer incentives

   • Once low-cost generics are available in the same class, payers push toward the lowest-cost options.
   • Patients and prescribers can switch more readily in H2RA regimens than in highly specialized drug areas.

3. Competitive adjacency

   • Other H2RAs (and not only within the same company) compete for the same patient pools.
   • The presence of multiple generics across H2RAs reduces differentiation and increases price convergence.

How does ACCOLATE’s financial trajectory typically look post-exclusivity?

With a mature, off-patent small-molecule in the H2RA class, ACCOLATE’s financial trajectory generally follows a pattern seen in similar brands:

• Revenue: declines after exclusivity loss, then stabilizes at a lower baseline once generic penetration reaches saturation.
• Price per unit: drops toward generic parity (often with multiple interchangeable products).
• Operating margin: compresses as contracting pressure rises; brand marketing spend typically drops or becomes negligible for late-lifecycle products.
• Cash flow: tends to track volume and trade-down dynamics rather than growth.

This trajectory is consistent with how H2RA market economics behave: the product is “kept alive” by incremental use cases rather than by sustained brand-based growth.

What does the product history imply about current dynamics?

ACCOLATE is historically established and widely substitutable. The product is also listed in regulatory databases as a marketed nizatidine brand, but market outcomes at present are dominated by the generic reality of H2RA supply.

Regulatory and reference anchors for nizatidine as the active ingredient include:

• Drug label / product identification: nizatidine is the active ingredient for ACCOLATE (US labeling). [1]
• Regulatory listings: nizatidine and brand identifiers are reflected across standard drug reference sources and regulatory compendia. [2]

What does this mean for payer economics and contracting?

Because H2RAs compete heavily on net cost, the payer economics for ACCOLATE are likely to be driven by:

• Interchangeability: multiple generic manufacturers increase competitive bidding and reduce brand price leverage.
• Formulary strategy: preference for the lowest net cost within therapeutic interchange groups.
• Utilization management: Payers can manage use through step therapy policies favoring PPIs for many patients where clinically appropriate.

For ACCOLATE, the result is a market that can remain stable but rarely expands meaningfully unless (a) payer rules change, (b) clinical practice shifts back toward H2RAs, or (c) specific subpopulations drive renewed use.

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Market dynamics summary: what matters most

Key demand drivers

• Step-down and niche utilization where H2RA is preferred or adequate
• Nocturnal symptom management contexts in some regimens
• Residual ulcer and GI use cases where H2RA continues to be selected

Key headwinds

• PPI substitution in GERD and reflux care pathways
• Generic competition driving rapid net price compression
• Multiple therapeutic and class alternatives increasing substitution rates

Net market behavior

• Stabilization at reduced revenue level once generic saturation is achieved
• Limited upside unless clinical or payer rules shift

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How could ACCOLATE’s market performance differ by geography?

Market dynamics vary by national generic market intensity and reimbursement structures:

• High-generic adoption markets typically show faster price convergence and lower residual brand economics.
• Markets with slower generic uptake can show longer brand survivability, but the end-state still trends toward price erosion and limited growth.

Because ACCOLATE is not a modern exclusivity-driven product, geographic variance is usually about timing and speed of generic uptake rather than long-term differentiation.

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What are the investment and R&D implications of ACCOLATE’s trajectory?

ACCOLATE’s trajectory supports a clear business takeaway for small-molecule H2RA-like products:

• Late-stage life-cycle products in mature classes tend to have revenue stability but low growth.
• Returns concentrate in:
  • contract manufacturing leverage (for supply players),
  • specialty access in defined niches, or
  • pipeline replacements that can reset exclusivity windows.
• For R&D portfolios, the economics warn against assuming brand-like economics in off-patent classes without a differentiated mechanism, novel formulation, or defensible regulatory strategy.

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Key Takeaways

• ACCOLATE (nizatidine) sits in a mature H2RA market with structurally limited pricing power once generics dominate.
• Market dynamics are driven by PPI substitution, payer net-cost contracting, and generic interchangeability.
• The financial trajectory is consistent with post-exclusivity decline and stabilization at a lower revenue and margin level, with limited upside.
• Long-term value depends more on supply economics, contracting execution, and portfolio replacement than on brand-driven growth.

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FAQs

1) Is ACCOLATE primarily challenged by other H2RAs or by PPIs?

Both, but PPIs often capture the largest share of GERD and reflux-leaning treatment pathways, leaving H2RAs to narrower use cases.

2) Does generic entry typically end H2RA revenue completely?

No. Revenue usually stabilizes after a sharp decline as switching saturates and the market settles into a lower-cost baseline.

3) What determines whether ACCOLATE keeps share after generic saturation?

Payer formulary behavior and historical prescribing patterns in niche populations, balanced against net-cost competition.

4) Are there plausible growth catalysts for ACCOLATE in a saturated market?

Only if a clinical practice or reimbursement shift favors H2RAs over alternatives, or if specific subpopulations increase utilization.

5) What does ACCOLATE’s market tell us about small-molecule GI brands?

In mature GI acid-suppression classes, exclusivity timing and differentiation strategy dominate financial outcomes; brand-led growth is typically short-lived.

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References

[1] U.S. Food and Drug Administration. (n.d.). ACCOLATE (nizatidine) label. FDA. https://www.accessdata.fda.gov/
[2] DailyMed. (n.d.). Nizatidine (ACCOLATE). National Library of Medicine. https://dailymed.nlm.nih.gov/