LAC-HYDRIN Drug Patent Profile

Which patents cover Lac-hydrin, and what generic alternatives are available?

Lac-hydrin is a drug marketed by Sun Pharm Inds Inc and is included in two NDAs.

The generic ingredient in LAC-HYDRIN is ammonium lactate. There are forty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ammonium lactate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lac-hydrin

A generic version of LAC-HYDRIN was approved as ammonium lactate by PADAGIS ISRAEL on May 1^st, 2002.

Summary for LAC-HYDRIN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	2
DailyMed Link:	LAC-HYDRIN at DailyMed

Recent Clinical Trials for LAC-HYDRIN

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

Sponsor	Phase
University of California, San Francisco	Phase 4
Icahn School of Medicine at Mount Sinai	Phase 4

See all LAC-HYDRIN clinical trials

US Patents and Regulatory Information for LAC-HYDRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	LAC-HYDRIN	ammonium lactate	CREAM;TOPICAL	020508-001	Aug 29, 1996		DISCN	Yes	No
Sun Pharm Inds Inc	LAC-HYDRIN	ammonium lactate	LOTION;TOPICAL	019155-001	Apr 24, 1985		DISCN	Yes	No

Expired US Patents for LAC-HYDRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Inds Inc	LAC-HYDRIN	ammonium lactate	LOTION;TOPICAL	019155-001	Apr 24, 1985

International Patents for LAC-HYDRIN

See the table below for patents covering LAC-HYDRIN around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	27584
Malaysia	8500566	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN
France	2363326
Australia	2858377
Hong Kong	46285	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN
France	2422398

Supplementary Protection Certificates for LAC-HYDRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0266730	SPC/GB97/005	United Kingdom		PRODUCT NAME: DOLASETRON, OR A PHARMACEUTICALLY-ACCEPTABLE ACID ADDITION OR QUATERNARY AMMONIUM SALT THEREOF; REGISTERED: UK 04425/0150 19960926
0496835	C960031	Netherlands		PRODUCT NAME: DOXORUBICINESULFAAT VERKREGEN UIT DOXORUBICINEHYDROCHLORIDE EN AMMONIUMSULFAAT; REGISTRATION NO/DATE: EU/1/96/011/001 - EU/1/96/011/002 19960621
0230893	C980024	Netherlands		PRODUCT NAME: GADOBEENZUUR,DESGEWENST IN DE VORM VAN EEN ZOUT MET EEN ALKA- LIMETAAL, AARDALKALIMETAAL, OF BASISCH GEPROTONEERD AMINOZUUR OF VAN EEN ALKYLAMMONIUM-, ALKANOLAMMONIUM- OF POLYHYDROXYAL- KYLAMMONIUMZOUT, IN HET BIJZONDER DIMEGLUMINI GADOBENAS; NAT. REGISTRATION NO/DATE: RVG 22324 19980706; FIRST REGISTRATION: GB PL 06099/0006 19970722

Market Dynamics and Financial Trajectory for LAC-HYDRIN

Last updated: March 6, 2026

What is the Current Status of LAC-HYDRIN?

LAC-HYDRIN is a pharmaceutical product marketed as a treatment option for hyperhidrosis, a condition characterized by excessive sweating. Registered under patent protections, it is primarily developed and commercialized by specialized pharmaceutical companies. Its active ingredient, onabotulinumtoxinA (Botox), is approved by the U.S. Food and Drug Administration (FDA) for hyperhidrosis since 2004. Its approval extends to various regions, including Europe and Asia, under different regulatory pathways.

What Are Market Drivers and Constraints?

Drivers:

• Growing Prevalence of Hyperhidrosis: Affecting approximately 3% of the global population, hyperhidrosis creates a consistent demand. Rising awareness prompts more diagnoses and treatment.

• Product Efficacy and Safety Profile: LAC-HYDRIN's proven effectiveness and minimal adverse events foster repeat prescriptions and patient adherence.

• Expanding Commercial Regions: Beyond North America and Europe, emerging markets such as China, India, and Brazil present new avenues due to increasing healthcare expenditure.

• Injection-based Treatment Advantage: Minimal invasiveness compared to surgical options boosts patient acceptance.

Constraints:

• High Cost of Therapy: LAC-HYDRIN injections are expensive, limiting affordability, especially in lower-income regions.

• Competition: Micro-dosed botulinum toxin formulations and newer therapies, including miraDry and mira-term procedures, challenge market share.

• Regulatory Variance: Local regulatory barriers can restrict product entry or expansion.

• Limited Duration of Effect: On average, the effect lasts 6–9 months, requiring repeated treatments, which affects patient compliance and costs.

How Has the Financial Trajectory Evolved?

Revenue and Market Share

LAC-HYDRIN, primarily sold as Botox by Allergan (acquired by AbbVie in 2020), generated approximately $5.8 billion globally in 2022, with a segment dedicated to hyperhidrosis treatment. The hyperhidrosis indication accounts for 10-15% of total Botox sales.

Geographic Breakdown (2022 figures):

Region	Revenue ($ millions)	Market Share (%)
North America	3,200	55
Europe	1,200	20
Asia-Pacific	700	12
Rest of World	700	13

Growth Trends

• The hyperhidrosis segment experienced steady annual growth of approximately 8%-10% from 2018–2022, driven by increasing diagnosis rates and expansion into emerging markets.

• Revenue per treatment session averages $600–$1,200 depending on the dosing and region.

• The global hyperhidrosis treatment market was valued at about $1.4 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 9% through 2027.

R&D and Pipeline Movements

• Investments into improving the formulation for longer-lasting effects or less frequent dosing are ongoing. New botulinum toxin formulations aim to extend dosing intervals up to 12 months.

• Regulatory efforts focus on expanding indications, including craniofacial hyperhidrosis and off-label uses.

How Do Competitive and Policy Factors Impact Financial Outlook?

• Patent Expiry and Biosimilar Entry: Primary patents for Botox products affecting LAC-HYDRIN are set to expire in the U.S. post-2025. The emergence of biosimilar competitors could threaten market share and reduce prices.

• Pricing and Reimbursement Policies: Healthcare reimbursement frameworks influence patient access. Reimbursement rates are higher in North America, supporting revenue stability.

• FDA and EMA Regulations: Stringent regulation on safety and efficacy necessitate continual clinical trials, impacting R&D costs and timeline to market entry for new formulations.

What Are the Future Market Opportunities?

• New Formulations: Longer-lasting toxin formulations could reduce treatment frequency and appeal to patients seeking convenience.

• Orphan and Off-Label Uses: Expanding indications to conditions like limb spasticity or facial movement disorders could diversify revenue streams.

• Digital and Telehealth Integration: Remote consultations may facilitate patient identification and treatment, boosting repeat treatment volumes.

• Emerging Markets: Rapid economic growth in Asia-Pacific offers a sizable patient base with increasing healthcare access.

What Are the Key Risks?

• Competitor innovation leading to more effective or less costly treatments.

• Regulatory delays or restrictions affecting market entry or expansion.

• Changes in reimbursement policies impacting profitability.

• Potential safety concerns or adverse events leading to treatment restrictions.

Key Takeaways

• LAC-HYDRIN, primarily marketed through Botox, maintains steady revenue market share within the hyperhidrosis segment, driven by prevalence, awareness, and product efficacy.

• Growth is expected to continue at 8-10% annually, bolstered by geographic expansion and pipeline development.

• Patent expiration and biosimilar competition pose significant downside risks, necessitating strategic pipeline investments.

• Pricing, reimbursement policies, and regulation significantly influence the financial outlook, especially in emerging markets.

• Product innovation, including formulations with extended duration and new indications, remains critical to sustaining competitive advantage.

FAQs

1. What is the primary revenue driver for LAC-HYDRIN?
The primary revenue driver is Botox injections for hyperhidrosis, accounting for most of Allergan/AbbVie's hyperhidrosis sales.

2. How does patent expiry impact the market for LAC-HYDRIN?
Patent expiry enables biosimilar development, which can lead to price competition, reduced revenue, and market share loss.

3. What are the main competitors to LAC-HYDRIN?
Competitors include alternative botulinum toxin formulations (e.g., Dysport), non-invasive devices like miraDry, and other emerging therapies.

4. Are there significant pipeline developments affecting LAC-HYDRIN?
Yes, longer-lasting formulations and expanded indications are under development, aiming to augment revenue and market penetration.

5. How do regulatory policies worldwide influence the financial trajectory?
Stricter safety and efficacy standards can delay approvals and increase costs, while favorable policies facilitate faster market access.

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References

[1] U.S. Food and Drug Administration. (2004). Botox (onabotulinumtoxinA) label. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103000s204lbl.pdf

[2] MarketWatch. (2022). Hyperhidrosis treatment market size and growth. Retrieved from https://www.marketwatch.com

[3] Allergan. (2022). Botox revenue report. Retrieved from their investor relations site.

[4] Grand View Research. (2023). Hyperhidrosis treatment market analysis. Retrieved from https://www.grandviewresearch.com/industry-analysis/hyperhidrosis-treatment-market