COLGATE TOTAL Drug Patent Profile

Which patents cover Colgate Total, and when can generic versions of Colgate Total launch?

Colgate Total is a drug marketed by Colgate Palmolive and is included in one NDA.

The generic ingredient in COLGATE TOTAL is sodium fluoride; triclosan. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium fluoride; triclosan profile page.

Summary for COLGATE TOTAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	46
Patent Applications:	3
DailyMed Link:	COLGATE TOTAL at DailyMed

Recent Clinical Trials for COLGATE TOTAL

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

Sponsor	Phase
Loma Linda University	PHASE3
Procter and Gamble	PHASE4
University of Sao Paulo	PHASE4

See all COLGATE TOTAL clinical trials

US Patents and Regulatory Information for COLGATE TOTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Colgate Palmolive	COLGATE TOTAL	sodium fluoride; triclosan	PASTE;DENTAL	020231-001	Jul 11, 1997		DISCN	Yes	No

Expired US Patents for COLGATE TOTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Colgate Palmolive	COLGATE TOTAL	sodium fluoride; triclosan	PASTE;DENTAL	020231-001	Jul 11, 1997
Colgate Palmolive	COLGATE TOTAL	sodium fluoride; triclosan	PASTE;DENTAL	020231-001	Jul 11, 1997
Colgate Palmolive	COLGATE TOTAL	sodium fluoride; triclosan	PASTE;DENTAL	020231-001	Jul 11, 1997
Colgate Palmolive	COLGATE TOTAL	sodium fluoride; triclosan	PASTE;DENTAL	020231-001	Jul 11, 1997
Colgate Palmolive	COLGATE TOTAL	sodium fluoride; triclosan	PASTE;DENTAL	020231-001	Jul 11, 1997
Colgate Palmolive	COLGATE TOTAL	sodium fluoride; triclosan	PASTE;DENTAL	020231-001	Jul 11, 1997
Colgate Palmolive	COLGATE TOTAL	sodium fluoride; triclosan	PASTE;DENTAL	020231-001	Jul 11, 1997

International Patents for COLGATE TOTAL

See the table below for patents covering COLGATE TOTAL around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	102494	Antibacterial, antiplaque, anticalculus oral composition
Taiwan	215056
Japan	H0383911	ANTI-BACTERIAL, ANTI-BACTERIAL FILTH AND ANTI-TARTAR COMPOUND FOR ORAL CAVITY
Greece	910100287
Norway	912589
Australia	671133
Greece	1004463	ΑΝΤΙΒΑΚΤΗΡΙΑΚΗΑΚΑΤΑΑΤΗΣΑΠΛΑΚΑΣΑΣΤΟΜΑΤΙΚΗΑΣΥΝΘΕΣΗ (ANTIPLAQUE ANTIBACTERIAL ORAL COMPOSITION)

Supplementary Protection Certificates for COLGATE TOTAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
1948158	93075	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
2822954	1890030-8	Sweden		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313

Market Dynamics and Financial Trajectory for Colgate Total

Last updated: February 28, 2026

Colgate Total, an oral health care product, is marketed by Colgate-Palmolive as an anticavity toothpaste with added antimicrobial properties. The product's market presence is shaped by oral hygiene trends, regulatory developments, consumer preferences, and competitive strategies.

Market Position and Competition

Colgate Total competes within the global toothpaste market, which was valued at approximately USD 23.1 billion in 2022. The product's unique selling points include long-lasting antimicrobial effects and cavity prevention, positioned against other multi-benefit toothpaste brands such as Crest Pro-Health, Sensodyne, and Aquafresh.

Global market share estimates place Colgate-Palmolive as the leader with approximately 40% of the toothpaste segment, with Colgate Total being a significant contributor. The product maintains a strong presence in North America, Asia-Pacific, and Latin America, accounting for roughly 50%, 25%, and 15% of revenue derived from toothpaste sales, respectively.

Competitive Landscape

Brand	Market Share (2022)	Key Features	Price Range (USD) per tube
Colgate Total	15-20%	Long-lasting antimicrobial, cavity prevention	3.50–4.50
Crest Pro-Health	10-12%	Gingivitis control, sensitivity relief	3.00–4.00
Sensodyne	8-10%	Sensitivity, enamel protection	4.50–6.00
Private Label	8-10%	Competitive pricing	2.00–3.50

Regulatory Environment and Reformulation Impact

The core ingredients of Colgate Total, primarily triclosan, faced regulatory scrutiny due to concerns over environmental and health effects. The US Food and Drug Administration (FDA) issued a final rule in 2016 classifying triclosan as "not generally recognized as safe" (GRAS) for use in antiseptic washes, leading to its removal from many consumer products.

In response, Colgate-Palmolive reformulated Colgate Total in 2019 to eliminate triclosan, replacing it with alternative antimicrobial agents such as stannous fluoride and zinc citrate, which meet regulatory standards. These reformulations aimed to maintain efficacy while complying with evolving regulations.

Market Trends and Consumer Behavior

The shifting focus toward natural and chemical-free oral care products impacts Colgate Total. Currently, there is increased consumer demand for:

• Natural ingredients
• Minimal chemical formulations
• Eco-friendly packaging
• Transparency about ingredient sourcing

This trend influences sales, especially in North America and Europe, where natural products accounted for roughly 30% of oral care market sales in 2022, growing at about 7% annually.

Revenue Projections and Financial Outlook

Colgate Total's contribution to Colgate-Palmolive’s oral care revenue stood at USD 1.5 billion in 2022, representing approximately 25% of total oral care sales. The product's growth rate has stabilized around 2-3%, reflective of market saturation and increased competition.

Financial forecasts suggest:

• Compound annual growth rate (CAGR) of 2-3% through 2027
• Rebounding sales in emerging markets driven by increasing oral health awareness
• Margins remain stable, supported by brand strength and product innovation

Investment Considerations and Risks

Investors should consider:

• Regulatory risks associated with ingredient bans and reformulations
• Market share erosion due to natural and organic competitors
• Potential decline in triclosan-reliant formulations affecting product efficacy perception

Colgate-Palmolive's strategy includes product pipeline diversification, emphasizing dual-function formulations, and sustainable packaging. These initiatives aim to sustain revenue streams, including Colgate Total.

Key Financial Metrics (2022)

Metric	Value
Total oral care revenue	USD 6 billion
Colgate Total revenue	USD 1.5 billion
Operating margin	22%
R&D expenditure	USD 300 million annually

Strategic Outlook

Colgate Total remains a core product with modifications to adapt to regulatory and market trends. Its future depends on maintaining antimicrobial efficacy, regulatory compliance, and consumer demand for effective oral health solutions.

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Key Takeaways

• Colgate Total controls a significant share of the global toothpaste market, with stable but plateauing growth.
• Reformulating to remove triclosan has maintained regulatory compliance but strained efficacy perceptions.
• Consumer preference shifts toward natural ingredients present a market threat.
• Revenue is expected to grow modestly at 2-3% CAGR through 2027, supported by emerging markets.
• Regulatory, competitive, and ingredient efficacy risks factor into the product's long-term trajectory.

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FAQs

1. What are the main competitors of Colgate Total?
Crest Pro-Health, Sensodyne, and private label brands are primary competitors, especially those emphasizing natural ingredients or specialized benefits.

2. How did regulatory changes affect Colgate Total?
The FDA’s 2016 ban on triclosan in consumer antiseptic products prompted reformulation in 2019, replacing it with alternative antimicrobials.

3. What is the outlook for sales growth of Colgate Total?
Sales are projected to grow at a 2-3% CAGR through 2027, driven by emerging markets and product innovations.

4. How does consumer demand impact Colgate Total’s strategy?
The trend toward natural and chemical-free products pressures the brand to innovate formulations and enhance transparency.

5. What financial risks does Colgate-Palmolive face regarding Colgate Total?
Ingredient restrictions and shifting consumer preferences could reduce sales, impacting margins and market share.

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References

1. Statista. (2023). Global toothpaste market size. Retrieved from https://www.statista.com
2. U.S. Food and Drug Administration. (2016). Final rule on triclosan. Retrieved from https://www.fda.gov
3. Euromonitor International. (2022). Oral care trends by region. Retrieved from https://www.euromonitor.com
4. Colgate-Palmolive. (2022). Annual Report.
5. Mintel. (2022). Natural oral care market report.