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
Patent Applications:	143
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	4,105,783

International Patents for LAC-HYDRIN

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

Country	Patent Number	Title	Estimated Expiration
South Africa	7705363
France	2422398
Kenya	3401	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN
France	2363326
Belgium	858404
Australia	2858377
Hong Kong	46285	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN

Supplementary Protection Certificates for LAC-HYDRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

LAC-HYDRIN: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is LAC-HYDRIN and where is it sold?

LAC-HYDRIN is a branded topical lotion formulation containing lactic acid (alpha hydroxy acid) used for keratolytic and emollient purposes, historically positioned in dermatology for dry, rough, scaly skin conditions (including hyperkeratotic disorders). The product has long-standing market presence, which typically points to a mature, low-growth commercial profile dominated by generics, formula variants, and payer/plan preference dynamics rather than patent-driven exclusivity.

How does the market structure shape LAC-HYDRIN pricing power?

The competitive setting for lactic-acid topical therapy is shaped by four structural forces:

• Generic and category substitution: Lactic acid topical therapies face frequent substitution at the pharmacy counter because multiple firms market equivalent or functionally overlapping keratolytic emollients.
• Channel concentration in dermatology and primary care formularies: Pharmacy benefit managers (PBMs) often apply step edits or cost caps in topical dermatology classes, compressing net pricing for older, non-protected brands.
• Low differentiation on function: When clinical outcomes are similar, formulary placement and discounting drive performance more than incremental claims.
• Private label and re-packaged strengths: Product formats and strength variations (commonly lactic acid concentration and base type) allow retailer and wholesaler strategies that compete on acquisition cost.

Implication for financial trajectory: For mature topical brands, revenue typically scales with population treatment incidence and dermatology demand, while margin expansion is constrained and net sales growth depends on formulary wins and contract pricing, not patent moat.

What demand drivers matter most?

Demand for lactic-acid topical therapy is largely driven by:

• Prevalence of chronic dry skin and hyperkeratotic conditions in aging populations.
• Dermatology practice flow (eczema, ichthyosis variants, callus and keratosis-associated presentations).
• Seasonality: Dry winter periods tend to lift usage in colder regions.
• Switching behavior: In topical categories, patients often switch based on tolerability (sting, dryness), perceived efficacy, and insurer copays.

How does reimbursement and payer behavior affect net revenue?

For mature topical products, net revenue is usually a function of:

• Formulary status: Whether the product is preferred, non-preferred, or subject to prior authorization or step therapy.
• Copay tier placement: Higher tiers reduce adherence and conversion.
• Brand-to-generic switching: If the class has multiple generic lactic-acid options, PBMs push utilization toward lower-cost agents.
• Manufacturer rebates: Net pricing often depends on rebate structures tied to utilization thresholds.

Net effect on financial trajectory: Even where gross price remains stable, net sales generally face downward pressure from utilization migration to cheaper equivalents and annual contract resets.

What product lifecycle forces apply to LAC-HYDRIN?

Given LAC-HYDRIN’s long-standing status, its lifecycle typically aligns with a late-maturity profile:

• Reduced promotional leverage relative to newer branded dermatology launches.
• Increased trade pressure from generics and authorized generics.
• Margin compression as payers and channels renegotiate.
• Incremental revenue from minor formulation or strength extensions, if any, rather than step-change adoption.

What is the likely financial trajectory (revenue, growth, and margins)?

Without audited financial statements for the specific branded SKU(s) labeled “LAC-HYDRIN,” the only defensible trajectory characterization is category-driven. For mature branded topical lactic-acid products, the expected path is:

Revenue

• Mid-to-low single digit growth or flat performance once category adoption is saturated and substitution accelerates.
• Temporary uplifts around seasonal peaks and localized formulary changes.

Gross-to-net conversion

• Gross-to-net typically compresses over time due to recurring rebate pressure, wholesaler channel incentives, and payer contract renegotiations.

Operating margins

• Margin headwinds persist as marketing intensity and trade spend rise to defend share against generics, while price cannot keep pace.

Portfolio risk

• Higher volatility from formulary tier changes rather than clinical discontinuations, since topical tolerability and class equivalence are well established.

Key market signals to track (commercial reality checks)

For LAC-HYDRIN specifically, the most decision-relevant indicators are not clinical. They are commercial:

1. Formulary status changes in major PBMs and state Medicaid programs.
2. Claims-based utilization versus generic lactic-acid topical comparators.
3. Channel inventory and sell-through (topicals are prone to stock swings with seasonal demand).
4. Price-per-unit trends at wholesaler and pharmacy levels after contract resets.
5. Competitive moves by other keratolytic emollients with better formulary fit (including urea-based and salicylic-acid alternatives, depending on payer edits).

Competitive set: what substitutes matter most?

In the keratolytic and dry-skin therapeutic neighborhood, substitution pressure commonly comes from:

• Urea-based creams (often used for xerosis and hyperkeratotic scaling).
• Salicylic-acid keratolytics (especially for callus and thickened skin presentations).
• Other alpha-hydroxy acid (AHA) moisturizers when treated as interchangeable by payers.
• Combination dermatology products where formularies bundle or prefer multipurpose options.

The practical point for LAC-HYDRIN is that its differentiation is formulation-based, while payer logic is typically class- and function-driven.

What does this mean for investors and R&D planners?

• Mature branded topical assets behave like cash engines, not growth engines. Their economics depend on share defense and contract management.
• R&D and lifecycle strategy must address substitution risk. For topical dermatology, the highest ROI is often in differentiation that payers can recognize (e.g., dosing frequency reduction, tolerance improvements that reduce discontinuations, or clear comparative evidence that drives formulary exceptions).
• Marketing spend is a defensive tool. If formulations are similar, promotional acceleration rarely offsets generic substitution for long.

---

Key Takeaways

• LAC-HYDRIN sits in a mature topical keratolytic category with high substitution and limited pricing power.
• Revenue dynamics are dominated by formulary status, PBM contracting, and generic migration, not patent exclusivity.
• Financial trajectory is expected to follow a late-maturity profile: flat-to-slight growth, net price pressure, and margin compression from trade and rebate dynamics.
• The most actionable monitoring set is utilization trends, formulary tier changes, and gross-to-net evolution.

FAQs

1) Is LAC-HYDRIN primarily a growth product or a cash-flow product?

It functions as a cash-flow oriented mature brand because topical lactic-acid therapies face ongoing substitution and net price compression pressure.

2) What drives LAC-HYDRIN sales performance most?

Formulary placement, payer copay tiering, and seasonal dry-skin demand generally dominate over new patient acquisition.

3) What is the biggest financial risk for LAC-HYDRIN?

Contracting outcomes that shift utilization to lower-cost lactic-acid generics or alternative keratolytics.

4) How do competitors typically impact LAC-HYDRIN margins?

Through lower acquisition costs and payer preference moves that increase brand switching, forcing higher trade or rebate to sustain share.

5) What commercialization lever has the highest ROI for a mature topical brand?

Securing and defending preferred formulary status and minimizing net pricing erosion via contract terms and utilization-based rebates.

---

References

[1] FDA. (n.d.). Labeling and prescribing information search. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] U.S. Patent and Trademark Office. (n.d.). Patent full-text and image database (PatFT)/Patent Application Full Text (AppFT). https://patft.uspto.gov/
[3] Centers for Medicare & Medicaid Services. (n.d.). Medicaid drug price and utilization resources. https://www.cms.gov/