PEPCID COMPLETE Drug Patent Profile

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

Pepcid Complete is a drug marketed by Kenvue Brands and is included in one NDA.

The generic ingredient in PEPCID COMPLETE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for PEPCID COMPLETE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	35
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEPCID COMPLETE
What excipients (inactive ingredients) are in PEPCID COMPLETE?	PEPCID COMPLETE excipients list
DailyMed Link:	PEPCID COMPLETE at DailyMed

Recent Clinical Trials for PEPCID COMPLETE

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

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2/Phase 3
Leidos Life Sciences	Phase 2
United States Department of Defense	Phase 2

See all PEPCID COMPLETE clinical trials

Pharmacology for PEPCID COMPLETE

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

Paragraph IV (Patent) Challenges for PEPCID COMPLETE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PEPCID COMPLETE	Chewable Tablets	calcium carbonate; famotidine; magnesium hydroxide	800 mg/10 mg/ 165 mg (OTC)	020958	1	2004-11-01

US Patents and Regulatory Information for PEPCID COMPLETE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000		OTC	Yes	Yes

International Patents for PEPCID COMPLETE

See the table below for patents covering PEPCID COMPLETE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	374800
Austria	A103080
Australia	534329
Australia	5597580
Belgium	882071
Canada	1134836	METHODE DE PREPARATION DE NOUVEAUX GUANIDINOTHIAZOLES (PROCESS FOR PREPARING NOVEL GUANIDINOTHIAZOLE COMPOUNDS)

Supplementary Protection Certificates for PEPCID COMPLETE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0247633	62/1997	Austria		PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
0933372	PA2008006	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372	SPC/GB08/018	United Kingdom		PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321

PEPCID COMPLETE market dynamics and financial trajectory: unit volume, pricing, channel mix, exclusivity/generic risk, and revenue outlook

Last updated: July 30, 2026

PEPCID COMPLETE (famotidine + calcium carbonate; antacid and H2 blocker combination) is an OTC gastrointestinal (GI) product whose financial trajectory is driven by (1) OTC pricing, (2) promotional intensity and retail shelf competition with other heartburn/indigestion brands, (3) generic and store-brand substitution for famotidine antacid formats, and (4) inventory and distribution dynamics typical of US OTC categories. A defensible revenue forecast and IP exclusivity view depends on package-specific data (SKU, strength, count), which is not provided here.

What is the current market position of PEPCID COMPLETE in US OTC heartburn and indigestion?

PEPCID COMPLETE sits in the OTC heartburn segment where consumers choose between:

• H2 blockers alone (famotidine)
• antacids alone (calcium carbonate products)
• combination products (H2 + antacid)
• proton pump inhibitors (PPIs) in OTC settings (omeprazole, etc.) where available and category-typical

In practice, PEPCID COMPLETE’s market position depends on whether consumers perceive it as faster relief than H2-only products and whether the added value justifies the price premium versus antacid-only options.

Which retailers and channels drive PEPCID COMPLETE velocity?

OTC heartburn SKUs typically concentrate in:

• mass retail and drugstore chains
• club and warehouse channels
• online marketplaces where price competition is intense

Channel mix changes can swing reported revenue even if unit demand is stable, because retail pricing and promotional allowances differ by channel.

How do price and promotions typically move PEPCID COMPLETE sales?

For OTC GI brands, key financial drivers are:

• shelf price changes (MSRP versus net price after trade and promotions)
• temporary retailer price cuts and couponing
• planogram visibility and merchandising support
• pack-count and “value pack” shifts that change average selling price (ASP)

Without SKU-level net sales and promotional spend, the direction and magnitude of impact cannot be quantified.

How does PEPCID COMPLETE compare with key competitors on product format and substitution risk?

PEPCID COMPLETE competes against three main substitution buckets:

H2 blocker substitutes

• famotidine monotherapy OTC products
• competing H2 blocker brands and generics

Substitution risk is high because H2-only products are often cheaper once branded premiums fall.

Antacid substitutes

• calcium carbonate antacids and multi-ingredient antacids
• “fast relief” formulations

Antacid competition can pressure PEPCID COMPLETE during periods when consumers prioritize speed and price over duration.

OTC PPI substitutes

• OTC omeprazole-based products (where applicable in the market)

PPIs can take share when consumer behavior shifts to prevention/recurrence management rather than episodic relief.

What market dynamics impact demand for PEPCID COMPLETE year over year?

Demand in OTC GI is typically influenced by:

• consumer incidence of heartburn and dyspepsia (seasonality and diet-related patterns)
• competitive promotional cycles and retailer inventory resets
• macroeconomic factors that alter brand versus private label choice
• consumer preference shifts between “quick relief” and “longer control”

Is PEPCID COMPLETE vulnerable to private label and generic substitution?

Yes, by structure. The active components are established OTC ingredients. Combination products can face substitution from:

• store-brand antacid + H2 formulations
• competing private label “complete relief” products
• lower-priced multi-ingredient antacid formats

The degree of vulnerability depends on whether competitors match perceived onset and convenience, plus whether PEPCID COMPLETE holds a branded price premium supported by marketing.

What is the financial trajectory of PEPCID COMPLETE: revenue growth, margin pressure, and cash-flow drivers?

A complete financial trajectory requires:

• historical net sales by quarter/year
• gross margin by SKU and package configuration
• trade spend and marketing expense
• chargebacks, returns, and inventory movements
• OTC category sell-through and retailer replenishment rates

No financials are supplied in the prompt, so a quantified trajectory (CAGR, margin, profit trend) cannot be produced without fabricating data.

When do patents, exclusivity, and regulatory status constrain or accelerate PEPCID COMPLETE competition?

PEPCID COMPLETE is an OTC combination of long-standing ingredients. For OTC brands like this, the relevant “exclusivity” concept is often not the same as prescription drug exclusivity, and competition typically hinges on:

• labeling and formulation differentiation
• brand marketing strength
• the presence of equivalent OTC competition
• manufacturing and packaging differences

No patent or regulatory dossier identifiers are provided in the prompt, so a time-based exclusivity schedule cannot be constructed.

What generic entry risks exist for PEPCID COMPLETE, and how do they show up in pricing?

Generic and private label risk typically manifests as:

• net price compression after equivalent products achieve distribution
• incremental promotional intensity to defend shelf share
• SKU rationalization by retailers and wholesalers
• pack-count changes that rebase ASP

Combination formats sometimes reduce direct substitution if competitors cannot replicate the perceived benefits at the same price point, but with established ingredients, replication is generally feasible.

How does PEPCID COMPLETE manufacturing and supply chain affect financial results?

OTC GI brands are sensitive to:

• raw material availability for calcium carbonate and famotidine intermediates
• packaging line capacity and lead times for blister and bottle formats
• distribution logistics and wholesaler ordering patterns
• quality control events that can trigger recalls or supply constraints

Supply disruption can temporarily lift sell-in but often harms sell-through and creates revenue volatility.

What do investors and licensors typically monitor for PEPCID COMPLETE?

For an OTC GI brand, watchpoints that correlate to financial outcomes:

• net sales trend by pack and strength (not just category)
• trade spend rate and promotional calendar intensity
• retailer inventory and reorder frequency
• online pricing parity and negative review patterns that reduce conversion
• competitive launch cadence of private label and branded equivalents

No such metrics are provided here, so a monitoring dashboard cannot be numerically specified.

Key Takeaways

• PEPCID COMPLETE’s market dynamics are dominated by OTC substitution between H2-only, antacid-only, and combination relief products.
• Financial performance is primarily a function of net pricing (after trade/promo), promotional intensity, and channel mix rather than IP-driven exclusivity.
• Generic and private label substitution risk is structurally high in OTC GI because the underlying actives are long established.
• A quantified financial trajectory and SKU-level revenue outlook cannot be produced from the information provided.

FAQs

1. Is PEPCID COMPLETE more price-competitive than famotidine-only OTC products?
2. Do combo antacid + H2 products gain share during periods of heightened promotional activity in OTC heartburn?
3. What retail channel best predicts PEPCID COMPLETE sell-through in OTC GI?
4. How do package size and count (e.g., value packs) typically affect PEPCID COMPLETE average selling price?
5. What competitive moves most commonly pressure OTC heartburn brands’ net revenue in the US?

References

1. None provided in the prompt.