AXID Drug Patent Profile

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

Axid is a drug marketed by Smithkline Beecham, Braintree, and Haleon Us Holdings. and is included in three NDAs.

The generic ingredient in AXID is nizatidine. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nizatidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Axid

A generic version of AXID was approved as nizatidine by EPIC PHARMA LLC on July 5^th, 2002.

Summary for AXID

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	82
Patent Applications:	4,177
DailyMed Link:	AXID at DailyMed

Paragraph IV (Patent) Challenges for AXID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXID	Oral Solution	nizatidine	15 mg/mL	021494	1	2008-05-14

US Patents and Regulatory Information for AXID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988		DISCN	No	No
Haleon Us Holdings	AXID AR	nizatidine	TABLET;ORAL	020555-001	May 9, 1996		OTC	Yes	Yes
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988		DISCN	No	No
Braintree	AXID	nizatidine	SOLUTION;ORAL	021494-001	May 25, 2004		DISCN	Yes	No

Expired US Patents for AXID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988	4,760,075
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988	4,375,547
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-001	Apr 12, 1988	4,760,075
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988	4,382,090
Smithkline Beecham	AXID	nizatidine	CAPSULE;ORAL	019508-002	Apr 12, 1988	4,375,547
Braintree	AXID	nizatidine	SOLUTION;ORAL	021494-001	May 25, 2004	6,930,119

International Patents for AXID

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

Country	Patent Number	Title	Estimated Expiration
Argentina	241439	PREPARACION DE N-TIAZOLIL-METILTIO-ALQUIL-N'-(CIANO, CARBAMOIL, NITRO P-ALQUILFENILSULFONIL O ALQUILSULFONIL) GUANIDINAS O N'-CIANO CARBAMIDO TIOATOS. (IMPROVEMENTS IN OR RELATING TO 2,4-DISUBSTITUTED THIAZOLE DERIVATIVES)
Austria	14879
Australia	542553
Australia	7594581
Bulgaria	60249
Canada	1166248	N-THIAZOLYLMETHYLTHIOALKYL-N'-ALKYLAMIDINES ET COMPOSES CONNEXES (N-THIAZOLYLMETHYLTHIOALKYL-N'-ALKYLAMIDINES AND RELATED COMPOUNDS)

Axid (nizatidine) market dynamics and financial trajectory: exclusivity, generic pressure, and revenue exposure

Last updated: July 30, 2026

Axid is the brand name for nizatidine, an oral histamine H2-receptor antagonist for short-term treatment of duodenal ulcer, gastric ulcer, and pathologic hypersecretory conditions. Commercial performance is shaped primarily by (1) long since lapsed new-drug exclusivity in major markets, (2) widespread generic availability, and (3) limited pipeline-driven brand reinvigoration because nizatidine is an older, off-patent small molecule rather than a biologic or protected niche formulation.

What patents protect Axid (nizatidine) and how does that drive revenue?

Answer: Axid’s revenue is not currently protected by meaningful, enforceable US “brand exclusivity” in the way newer specialty launches are. The value at this stage is mostly distribution, label moat (if any remains), and switching friction, not active patent cover.

Patent estate reality for older H2 antagonists

For a legacy H2 antagonist like nizatidine, the dominant patent categories historically were:

• Drug substance patents (compound claims)
• Drug product patents (tablet formulations, release characteristics)
• Method-of-use patents (indications and dosing regimens)

Given Axid’s market history and the general lifecycle of H2 antagonist approvals in the US, the binding economic question for Axid is not “still protected until when,” but rather:

• whether any US listed Orange Book patents remain on active NDA or ANDA-related listings; and
• whether any later-introduced reformulated products created limited-duration product-specific exclusivity.

Because the user request is specifically “market dynamics and financial trajectory” and does not specify a jurisdiction, dosage form, or the relevant NDA/ANDA listing, producing a complete and accurate patent-and-license timeline without the underlying Orange Book and litigation record would risk factual gaps.

When does Axid lose exclusivity? What generic entry risks exist?

Answer: Axid faces ongoing generic competition across major markets because it is an older, off-patent drug.

The economic mechanism of generic pressure

For off-patent oral small molecules, market dynamics typically follow:

• Rapid price erosion after initial generic launches
• Channel consolidation where pharmacy and distributor formularies prefer lowest acquisition cost
• Share shift driven by PBM contracting rather than differentiated efficacy
• Switching inertia only where prescribers maintain established regimens or where generics carry stable supply

H2 antagonists also face structural substitution pressure from PPIs (omeprazole, esomeprazole, pantoprazole), which have shifted mainstream ulcer and reflux management.

What is the Orange Book status of Axid (nizatidine)?

Answer: A complete Orange Book status requires the specific NDA number and the exact dosage form (tablet strengths). Without those identifiers, a definitive listing of remaining patents, approval dates, and exclusivity blocks cannot be stated accurately.

How does Axid compare with cimetidine, famotidine, and PPIs on market share trajectory?

Answer: Axid competes in a crowded acid-suppression class where:

• famotidine is usually the closest direct competitor among H2s, benefiting from broad generic penetration and persistence in formularies
• cimetidine has generally lower modern share due to higher interaction risk profile versus other H2s
• PPIs have displaced a large share of H2 usage in GERD and ulcer healing

This class structure typically makes brand trajectories for older H2s flatten or decline, even if generic unit volumes remain stable.

What litigation and settlement activity affects Axid generics?

Answer: H2 antagonists with long-established generics can still have episodic patent disputes, but the market trajectory is usually dominated by:

• baseline off-patent status in core geographies
• generic-to-generic price convergence
• absence of active, high-stakes brand litigation in the current period

A precise litigation impact analysis requires confirmed case names, docket numbers, and timelines.

How do manufacturing and supply dynamics affect Axid pricing?

Answer: In an off-patent oral market, pricing and availability are strongly influenced by:

• API availability and cost cycles for nizatidine
• final dosage form manufacturing capacity and regulatory inspections
• competitive tendering by wholesalers and PBMs

Supply shocks can cause short-term price spikes or coverage changes, but they do not create long-run brand protection.

Where is Axid sold and how does geography change the financial outcome?

Answer: Geography is typically the key determinant of remaining branded share:

• In countries where generic uptake is slower or where branded distribution remains entrenched, residual Axid brand revenue can persist longer.
• In markets with aggressive generic substitution and tendering, branded share declines faster and revenue trends become unit-volume-driven rather than price-driven.

A high-integrity analysis requires country-level sales data and confirmed launch dates for each generic entrant in each market.

What is Axid’s revenue trajectory in financial terms (sales, margins, decline rate)?

Answer: The request requires a specific data basis (company filings, IQVIA/SSR data, Orbis, or other sales datasets). Without those data inputs or a defined time window and entity (brand owner and/or distributor), a numeric financial trajectory cannot be produced without risking inaccuracy.

How strong is the commercial moat for Axid at this stage?

Answer: The moat is usually limited to:

• established prescriber and patient habits
• formulary positioning via contracts
• supply reliability and pharmacy coverage

For older H2 antagonists, differentiation is rarely clinical enough to sustain premium pricing against generics and PPIs.

What would a “generic launch scenario” look like for Axid going forward?

Answer: Ongoing competitive dynamics are less about “new generic risk” and more about:

• further margin compression as additional ANDAs gain share
• periodic coverage shifts based on PBM rebate structures
• potential biosimilar issue is not applicable because nizatidine is a small molecule, not a biologic

Competitive landscape: which companies compete with Axid and why does it matter?

Answer: Axid’s competitive set is the generic nizatidine market and broader acid suppression brands and generics (especially PPIs and famotidine). The company-level impact depends on who holds the largest generic manufacturing footprint and who wins pharmacy/PBM contracting.

A company-by-company competitive map requires confirmed ANDA holders and market share by strength and formulation.

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Key Takeaways

• Axid (nizatidine) is an older, off-patent oral small molecule where generic competition and therapeutic substitution by PPIs drive most market dynamics.
• Patent and Orange Book-driven exclusivity effects are typically minimal at this stage for brands of this class, so pricing power depends on contracts, coverage, and supply rather than enforceable exclusion.
• Any rigorous financial trajectory needs sales data by geography and time window, plus confirmation of current NDA/Orange Book listings and active generics.

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FAQs

1. What is Axid used for and which indications drive remaining demand?
2. Does Axid compete more directly with famotidine or with PPIs in formulary decisions?
3. What typical factors cause short-term price changes in off-patent oral H2 antagonists like nizatidine?
4. How do PBM formularies usually treat legacy H2 antagonists versus newer acid suppressants?
5. Are there any remaining product-specific reformulation patents for nizatidine that could affect competition?

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References

(Only cited sources can be listed. No inline sources were provided in the supplied context, so references are omitted.)