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In our previous bulletin, we discussed the legal considerations related to branding prescription drugs in Canada.1 In this bulletin, we focus on legal considerations related to over-the-counter drugs ("OTCs") in Canada.
Unlike prescription drugs, OTCs compete in a consumer-driven market. Therefore, branding may play an even greater commercial role for OTCs than prescription drugs. In this bulletin, we outline the key considerations for life sciences companies when developing brand names for OTCs in Canada and abroad.
Overview of Health Canada Rules on OTC Branding
OTCs are regulated health products subject to naming rules and advertising standards, and product name review is part of Health Canada's pre-market regulatory approval process for such non-prescription drugs. Similar to prescription drugs, the proposed brand name for OTCs must not be mistaken for another authorized health product in Canada.2
Currently, Health Canada has issued a guidance document on brand name review only for prescription drugs.3 A separate guidance document for non-prescription products is being developed.4 Until a dedicated framework is established, one may consider referring to the prescription drug guidance when preparing OTC brand-name submissions.5 For an OTC, if the proposed brand name is neither exclusively descriptive of the product's proposed therapeutic or functional claims (e.g., its intended use or effects) nor a proper or common name of its ingredient(s), a "Look-Alike, Sound-Alike" (LASA) assessment6 may be required to determine whether the proposed brand name may be confusing with an existing health product authorized for use in Canada,7 as is the case for a prescription drug.8
Balancing Consumer Appeal with Regulatory Constraints
Compared to prescription drugs, OTC brand names face greater pressures to appeal to consumers, as they often compete with other brands on retail shelves. This pressure may cause companies to pursue brand names that are suggestive, evocative, or emotionally driven (e.g., CalmEase, QuickRelief), or that use superlative language. However, these marketing considerations must be balanced against regulatory concerns that Health Canada screens for, including but not limited to:
- misleading with respect to product composition;
- unsubstantiated superiority claims (e.g. "better", "richer", "stronger");
- minimization of product risk (e.g. "safe");
- undue emphasis on certain ingredients or a secondary attribute (e.g. "non-drowsy"); and
- similarity or potential confusion with the names of other products (including discontinued products).9
Trademark Considerations
As with any trademark, a clearance search10 should be performed in Canada on a proposed brand name for an OTC. Filing trademark applications early – before seeking Health Canada approval for the name – should be considered as well, as the trademark registration process in Canada is generally longer than Health Canada's approval process. In addition, trademark applications are examined in the order in which they are received and therefore applicants are generally encouraged to file their trademark applications as soon as possible.
In Canada, although trademark rights may arise through use, registration provides stronger, nationwide protection and better enforcement mechanisms. For OTCs intended for multiple jurisdictions, it is also important to consider jurisdiction-specific trademark availability and registration requirements, as these can differ between jurisdictions.
Steps that producers of OTCs may wish to take when seeking trademark protection in and beyond Canada include:
- registering the brand name early in Canada;
- coordinating with international counsel on jurisdiction-specific advertising, naming rules, translations and trademark clearance; and
- filing trademark applications in target jurisdictions, either directly or via the Madrid Protocol.11
In some jurisdictions, particularly those with greater incidences of trademark squatting activity, defensive filing strategies12 may be employed.
For brands to be marketed in a multicultural or multilingual context, it is important to consider potential issues related to translation or transliteration. A proposed brand name may convey negative meanings, unintended slang, offensive phonetics, or misleading therapeutic implications in the local language or cultural context.
OTC branding strategies in Canada should address linguistic and cultural issues arising from the French language13 and the French-Canadian cultural context. If you use a French version of the brand name, a separate trademark application for the French mark may also be appropriate.14
Using Brand Names Carefully: Preventing Genericide
Popular OTC brand names can be vulnerable to genericide if they become widely used household terms for a type of product rather than identifying a specific product. Genericide occurs when a trademark is used in common parlance to describe the goods themselves, which can lead to the loss of distinctiveness of a mark and consequently the loss of trademark protection.
Brand owners may reduce the risk of genericide by:
- using the trademark as an adjective rather than a noun, with descriptive terms following the brand name (e.g. "BRAND NAME Cold Medication");
- using trademark indicators (i.e., using superscript "TM" for unregistered trademarks and ® for registered trademarks); and
- maintaining clear distinction between the brand name and the OTC's generic or chemical name in communications and marketing materials.
Conclusion
Despite the commercial pressure on OTC brands to appeal to consumers, Canadian branding regulations can limit the options for brand names. Proposed OTC brand names require clearance checks similar to those for prescription drugs. Selecting names that are creative, compliant, and culturally neutral across jurisdictions is important. Further, proper use, notice and enforcement of the trademark is key to preventing the brand name from becoming generic.
As a national firm with strong global connections, our team of legal professionals provides integrated IP, regulatory, and commercial advice to support clients with brand development and commercialization in Canada and internationally.
Footnotes
1 Yue Fei, Aki Kamoshida, Pablo Tseng and Hugo Mak (Summer Articled Student), "Naming Prescription Drugs: Navigating Regulatory and Trademark Challenges", McMillan LLP, (6 August 2025) ["Naming Prescription Drugs"], available here.
2 See Health Canada, Guidance Document – Questions and Answers: Plain Language Labelling Regulations for Non-Prescription Drugs (Ottawa, Health Canada, 1 April 2020) ["PLL Regulations Guidance"], ss 3-3.1.
3 See Health Canada, Guidance Document for Industry – Review of Drug Brand Names (Ottawa, Health Canada, 13 June 2015).
4 See Health Canada, Frequently Asked Questions – Guidance Document for Industry – Review of Drug Brand Names (Ottawa, Health Canada, 15 July 2015) ["Brand Name Guidance"].
5 PLL Regulations Guidance, supra note 2, s 3.3.
6 Brand Name Guidance, supra note 4, s. 2.3.
7 PLL Regulations Guidance, supra note 2, s 3.2.
8 See our previous bulletin.
9 PLL Regulations Guidance, supra note 2, Appendix B.
10 See our previous bulletin, Naming Prescription Drugs (available here) for more information on what this search entails.
11 See Canadian Intellectual Property Office, "International Trademarks under the Madrid Protocol", available here.
12 Defensive filing is a filing strategy where a trademark owner registers their mark for goods or services they do not currently offer, but might in the future, or to prevent others from registering similar marks for those goods or services. These filings are often used to prevent potential infringers or to protect a brand's reputation from dilution.
13 Food and Drug Regulations, CRC, c 870, A.01.015, which requires any statement, information, or declaration required on a drug label must be in either French or English, in addition to any other language; Charter of the French Language, CQLR c C-11, s. 51.
14 Additional considerations may arise from use and registration of trademarks in Quebec, which are not fully addressed in this article. Please contact a member of the McMillan team for further guidance on the recent changes to the Regulations related to Bill 96 and the Charter of the French Language.
The foregoing provides only an overview and does not constitute legal advice. Readers are cautioned against making any decisions based on this material alone. Rather, specific legal advice should be obtained.
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