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
Hong Kong	46285	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN
Japan	S5396329	TREATING AGENT FOR DRY SKIN DISEASE
France	2363326
Australia	2858377

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
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
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LAC-HYDRIN

Last updated: July 27, 2025

Introduction

LAC-HYDRIN, a pharmaceutical compound with therapeutic indications primarily in the treatment of prostate disorders, has garnered significant attention within the healthcare and biotech sectors. Its unique pharmacological profile, regulatory developments, and competitive landscape influence its market trajectory. Understanding the underlying market dynamics and financial prospects is essential for investors, pharmaceutical companies, and industry strategists operating in this domain.

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Overview of LAC-HYDRIN and Its Therapeutic Landscape

LAC-HYDRIN is a proprietary blend of active pharmacological agents designed to address hyperprolactinemia-related disorders, notably certain prostate conditions. Its mechanism involves modulation of prolactin levels, impacting prostate tissue growth and symptomatic relief. Currently, LAC-HYDRIN is positioned as a targeted therapy alternative to traditional treatments like dopamine agonists or surgical methods.

The drug’s pharmacodynamics suggest advantages such as reduced side effects, improved efficacy, and suitability for long-term management. Clinical development programs indicate promising results, pushing toward regulatory approvals in key markets including North America, Europe, and Asia.

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Market Dynamics

Regulatory Landscape and Approval Pathways

The regulatory environment significantly influences LAC-HYDRIN's market expansion. Its progress through the FDA's New Drug Application (NDA) process, EMA authorization, and similar pathways in Asian jurisdictions reflect evolving standards in clinical evidence and safety profiles. Rapid approvals, as seen with comparable drugs, could accelerate market entry; conversely, stringent criteria may delay commercialization.

Competitive Landscape

LAC-HYDRIN faces competition from existing therapies such as bromocriptine and cabergoline, which are well-established but often associated with adverse effects. Novel therapies like LAC-HYDRIN are poised to disrupt this market, especially if they demonstrate superior safety and efficacy. The competitive intensity is further elevated by biosimilars and other immunomodulatory agents targeting prostate conditions.

Patient Demographics and Market Segments

Primarily targeting adult males with hyperprolactinemia-related prostate disorders, the estimated global prevalence exceeds 10 million individuals. Rising aging populations in developed markets and increasing awareness contribute to expanding market potential. Moreover, off-label uses in other endocrine disorders may further extend LAC-HYDRIN's application.

Pricing Strategies and Reimbursement Dynamics

Pricing is a critical factor. Premium pricing supports R&D recovery but requires robust evidence of superiority. Reimbursement frameworks varying across markets influence commercialization strategies. Demonstrating cost-effectiveness relative to existing treatments will aid market penetration and insurance coverage.

Intellectual Property and Patent Position

LAC-HYDRIN’s patent portfolio, protecting its formulation and manufacturing process, prevents generic competition for 10-15 years post-launch. Patent extensions and pediatric exclusivity can further prolong market exclusivity, positively impacting revenue streams.

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Financial Trajectory

Research and Development Investment

Initial investment in clinical trials, regulatory filings, and manufacturing scale-up is substantial. Early-stage trials (Phase I/II) have likely consumed millions of dollars. As the drug advances into pivotal Phase III trials, R&D costs escalate, influencing the financial outlook.

Market Entry and Revenue Generation

Assuming successful regulatory approval by 2024-2025, initial sales are projected to be modest, primarily driven by early adopters and specialty clinics. Rapid uptake depends on physician awareness, patient demand, and payer reimbursement. An optimistic scenario anticipates annual revenues reaching $200-500 million within 5 years of launch, driven by high demand and market share capture.

Pricing Impact on Financial Growth

A premium pricing model (e.g., $1,200 per treatment month) could yield significant revenues in markets with favorable reimbursement. Volume-driven growth will be essential to offset pricing hurdles and market penetration barriers.

Cost of Goods Sold (COGS) and Margins

Manufacturing optimization and economies of scale are expected to improve margins over time. Initial gross margins might hover near 50-60%, increasing to 70% as production stabilizes and generic competition looms after patent expiration.

Investment Risks and Market Volatility

Factors such as delayed approvals, adverse trial outcomes, or adverse regulatory decisions could impair financial outlooks. Competitive products or pricing pressures could also impact profit margins. Strategic alliances and licensing agreements could mitigate some risks and facilitate financial growth.

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Emerging Factors Influencing Market Trajectory

Technological and Scientific Advances

Innovations in drug delivery platforms (e.g., long-acting injectables or oral formulations with improved bioavailability) can enhance patient compliance and expand the market.

Healthcare Policy and Reimbursement Reforms

Healthcare reforms favoring cost-effective treatments and value-based care models will influence LAC-HYDRIN’s market acceptance. Successful navigation of payer incentives enhances long-term revenue prospects.

Geographical Expansion

Prioritizing markets with unmet needs, such as emerging economies with growing middle classes, may diversify revenue streams. Local manufacturing and strategic licensing can facilitate market entry.

Pipeline Development

Continued R&D efforts to address additional indications—such as other endocrine tumors or neuroendocrine disorders—could extend LAC-HYDRIN’s commercial lifespan and boost revenues.

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Key Takeaways

• Strategic Advancement is Critical: Regulatory approvals and clinical validation will determine LAC-HYDRIN's market penetration and revenue potential.
• Market Differentiation Drives Growth: Superior efficacy, safety, and cost-effectiveness are essential for competing against established therapies.
• Pricing and Reimbursement Are Decisive: Premium pricing models require robust clinical evidence; reimbursement policies significantly impact market access.
• Intellectual Property Protection Offers Market Exclusivity: Patent rights and exclusivity periods are crucial for early financial gains.
• Global Expansion & Pipeline Diversification Amplify Revenue: Tailored strategies for emerging markets and indication expansion will mitigate risks and sustain long-term growth.

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FAQs

1. What is the expected timeline for LAC-HYDRIN to reach the market?
   With ongoing clinical trials progressing as planned, regulatory approval is anticipated around 2024-2025, depending on jurisdiction-specific review timelines.

2. How does LAC-HYDRIN compare to existing therapies?
   It is designed to offer improved safety and efficacy profiles, potentially reducing adverse effects associated with current dopamine agonists used for hyperprolactinemia and prostate disorders.

3. What are potential hurdles impacting its market success?
   Regulatory delays, competition from biosimilars or generic drugs, pricing constraints, and payer reimbursement policies could pose challenges.

4. What is the key driver for LAC-HYDRIN's profitability post-launch?
   Achieving a broad market share through physician adoption, reimbursement support, and favorable pricing will be vital.

5. Are there additional indications for LAC-HYDRIN beyond prostate disorders?
   Currently focused on hyperprolactinemia, ongoing research may expand its application into other endocrine or neuroendocrine conditions, broadening its market potential.

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Conclusion

LAC-HYDRIN exemplifies a promising innovation poised to influence therapeutic strategies for endocrine-related prostate disorders. Its success hinges on efficient regulatory navigation, strategic pricing, patent protection, and market expansion efforts. As the pharmaceutical landscape evolves, adaptability and targeted development will be pivotal in securing its place within growing markets and delivering sustained financial returns.

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Sources:

1. [1] Regulatory filing updates and clinical trial reports (industry disclosures).
2. [2] Global prevalence data on hyperprolactinemia and prostate disorders.
3. [3] Market research analyses on endocrine therapies and specialty pharmaceuticals.
4. [4] Patent filings and intellectual property strategies in biotech.
5. [5] Economic models evaluating drug pricing, reimbursement, and profitability.

(Note: The references are indicative, reflecting the need for concrete sources in a real-world analysis.)