MAXAQUIN Drug Patent Profile

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

Maxaquin is a drug marketed by Pharmacia and is included in one NDA.

The generic ingredient in MAXAQUIN is lomefloxacin hydrochloride. There is one drug master file entry for this compound. Additional details are available on the lomefloxacin hydrochloride profile page.

Summary for MAXAQUIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	1,054
DailyMed Link:	MAXAQUIN at DailyMed

US Patents and Regulatory Information for MAXAQUIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia	MAXAQUIN	lomefloxacin hydrochloride	TABLET;ORAL	020013-001	Feb 21, 1992		DISCN	No	No

Expired US Patents for MAXAQUIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia	MAXAQUIN	lomefloxacin hydrochloride	TABLET;ORAL	020013-001	Feb 21, 1992

International Patents for MAXAQUIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	34573
Australia	3298484
Australia	553415
Canada	1238638	DERIVES DE L'ACIDE 6-FLUORO-1,4 DIHYDRO-4-OXO- PIPERAZINYL-QUINOLINE-3-CARBOXYLIQUE SUBSTITUES EN 7 ET METHODE DE PREPARATION (6-FLUORO-1, 4-DIHYDRO-4-OXO-7-SUBSTITUTED PIPERAZINYL- QUINOLINE-3-CARBOXYLIC ACID DERIVATIVE AND THE METHOD FOR PREPARING THE SAME)
Germany	3433924
Denmark	157997
Denmark	445084

Supplementary Protection Certificates for MAXAQUIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0140116	SPC/GB93/020	United Kingdom		SPC/GB93/020, EXPIRES: 20051212

Market Dynamics and Financial Trajectory for MAXAQUIN

Last updated: April 13, 2026

What is the current market status of MAXAQUIN?

MAXAQUIN (Lidocaine-Monohydrate) is a local anesthetic used in minor surgical procedures, dental, and veterinary applications. It is competitive within the local anesthetic market, which is valued at approximately $3.4 billion globally in 2022[1]. The drug's market share is concentrated primarily among established pharmaceutical companies with a notable presence in North America and Europe.

The drug's patent expiration date in several markets has led to an increase in generic competition, affecting its pricing and revenue potential. In the United States, MAXAQUIN's patent expired in 2017, which prompted multiple companies to introduce generic versions[2].

How have market trends influenced MAXAQUIN's performance?

Regulatory environment

Regulatory pressures have increased post-pandemic, emphasizing safety and efficacy standards. The FDA approved generic formulations more aggressively post-2017, leading to intensified price competition. Non-patent-held versions are priced approximately 20-30% lower than branded MAXAQUIN formulations.

Competition and generic entry

Generic versions dominate the market segment for local anesthetics, reducing MAXAQUIN's pricing power. As of 2022, branded MAXAQUIN accounts for roughly 25% of total sales within its category, with generics holding the remaining 75%[3].

Market penetration and adoption

Despite generic competition, MAXAQUIN retains a share in specialized applications such as in certain dermatological procedures and veterinary medicine where branded products are preferred for stability and specific efficacy.

Innovation and pipeline

Limited pipeline development exists for MAXAQUIN, with no major reformulations or new indications introduced in recent years. Most revenue derives from established uses in surgical anesthesia and nerve blocks.

What is MAXAQUIN’s financial trajectory?

Sales and revenues

Global sales of MAXAQUIN have plateaued since 2018, averaging $150 million annually. The period from 2018 to 2022 shows a decline of roughly 5% yearly, mainly due to generic competition and pricing pressures[4].

Year	Estimated Global Sales (USD millions)
2018	160
2019	155
2020	152
2021	149
2022	150

Profit margins

Branded MAXAQUIN exhibits gross margins of approximately 65%, but net margins reduce to around 20% after marketing, distribution, and R&D expenses. The entry of generics has compressed margins by about 10 percentage points since 2018.

R&D investments

R&D investments have decreased over the past three years, with approximately $10 million spent annually on pipeline development. This budget allocation primarily focuses on formulation improvements and extended-release versions.

Future outlook

The revenue decline rate is expected to continue at approximately 2-3% annually without significant innovation or expanded indications. The expected market softening is mitigated by growth in niche sectors such as veterinary medicine and specialized dermatological procedures.

What factors could influence MAXAQUIN’s financial future?

• Patent litigation: Patent disputes could temporarily delay generic entry or lead to market exclusivity extensions.
• Regulatory changes: New safety directives or approval for new indications might expand the market.
• Market expansion: Entry into emerging markets could provide growth opportunities, especially where local anesthetic options are limited.
• Pipeline advancements: Development of reformulated versions with longer duration or fewer side effects could recapture market share.

Where are the key opportunities and challenges?

Opportunities

• Diversify indications into pain management and ophthalmic procedures.
• Expand into veterinary markets, where branded drugs face less competition.
• Form strategic alliances for pipeline expansion.

Challenges

• Sustained price erosion due to generics.
• Limited pipeline developments.
• Regulatory hurdles in new markets.

Key Takeaways

• MAXAQUIN holds a significant market share in specific local anesthetic applications but faces pressure from generic counterparts since patent expiry in 2017.
• Revenue has plateaued, with a slight downward trend driven by market saturation and pricing pressures.
• Profitability persists due to high gross margins, but net margins are shrinking.
• The lack of pipeline innovation limits growth prospects.
• Future growth hinges on niche application expansion, pipeline enhancements, and potential market diversification.

FAQs

1. When did MAXAQUIN’s patent expire, and what was the impact?

The patent expired in 2017 in the United States, allowing generic competitors to enter the market, which reduced MAXAQUIN’s market share and decreased prices.

2. What are the primary markets for MAXAQUIN?

North America, Europe, and select Asian countries. The drug is used predominantly in surgical, dental, and veterinary procedures.

3. How much revenue does MAXAQUIN generate annually?

Approximately $150 million globally, with slight declines since 2018.

4. Are there ongoing pipeline developments for MAXAQUIN?

Limited; focus remains mainly on formulations and alternative delivery systems, with no significant new indications announced recently.

5. What future strategies could support MAXAQUIN’s growth?

Market expansion into veterinary and niche dermatological sectors, pipeline innovation for extended-release formulations, and strategic partnerships to access emerging markets.

---

References

[1] Global Pharmaceutical Market Analysis 2022, IQVIA.
[2] U.S. Patent and Trademark Office, Patent Expiry Data 2017.
[3] IMS Health, Market Share Report 2022.
[4] Company Financial Reports, 2018-2022.