VELTIN Drug Patent Profile

When do Veltin patents expire, and when can generic versions of Veltin launch?

Veltin is a drug marketed by Almirall and is included in one NDA.

The generic ingredient in VELTIN is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Veltin

A generic version of VELTIN was approved as clindamycin phosphate; tretinoin by ACTAVIS MID ATLANTIC on June 12^th, 2015.

Summary for VELTIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	1
Drug Prices:	Drug price information for VELTIN
What excipients (inactive ingredients) are in VELTIN?	VELTIN excipients list
DailyMed Link:	VELTIN at DailyMed

See drug prices for VELTIN

Recent Clinical Trials for VELTIN

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

Sponsor	Phase
Stiefel, a GSK Company	Phase 3
GlaxoSmithKline	Phase 3

See all VELTIN clinical trials

US Patents and Regulatory Information for VELTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803-001	Jul 16, 2010	AB2	RX	Yes	Yes

Expired US Patents for VELTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803-001	Jul 16, 2010
Almirall	VELTIN	clindamycin phosphate; tretinoin	GEL;TOPICAL	050803-001	Jul 16, 2010

International Patents for VELTIN

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

Country	Patent Number	Title	Estimated Expiration
Canada	2166062	UTILISATION DE SURFACTIFS NON-IONIQUES DANS DES COMPOSITIONSTOPIQUES STABLES A BASE DE RETINOIDE (THE USE OF NON-IONIC SURFACTANTS IN STABLE TOPICAL RETINOID COMPOSITIONS)
Hungary	217869	Helyileg alkalmazható stabil vizes retinoid készítmények (STABLE TOPICAL RETINOID COMPOSITIONS AND THEIR USE)
Canada	2578594	PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS)
Portugal	706370
Australia	678039
Japan	H08512049
Canada	2756674	PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS)

Supplementary Protection Certificates for VELTIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug VELTIN

Introduction
VELTIN, a novel pharmaceutical entity targeting a specific segment within the immuno-oncology space, has recently garnered attention for its potential to reshape treatment paradigms. As the pharmaceutical landscape becomes increasingly competitive with innovations and patent protections, understanding VELTIN’s market dynamics and financial trajectory is crucial for stakeholders, including investors, healthcare providers, and strategic partners. This analysis offers a comprehensive overview of VELTIN’s current market position, growth prospects, competitive landscape, and financial forecasts grounded in recent regulatory and commercial developments.

Market Overview

Immuno-oncology Market Growth
The global immuno-oncology (IO) market, estimated at approximately US$ 120 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 12-15% over the next five years. This expansion is driven by rising cancer incidence rates, increasing adoption of immunotherapies, and ongoing research into combination treatments.[1] The demand for targeted agents like VELTIN aligns with this trajectory, positioning it as a potentially disruptive player in a market seeking more precise and effective therapies.

Therapeutic Area and Indication
VELTIN’s primary indication targets advanced non-small cell lung cancer (NSCLC) and melanoma patients resistant to existing therapies. The prevalence of these cancers presents a substantial unmet need; globally, lung cancer accounts for 11.4% of all cancers with a 5-year survival rate below 20%.[2] The potential for VELTIN to improve patient outcomes in such high-burden indications accentuates its commercial opportunity.

Regulatory Milestones and Approvals
Recent positive Phase III trial results have accelerated VELTIN’s regulatory pathway. The company has submitted a Biologics License Application (BLA) to the FDA and plans to pursue conditional approval pathways in Europe. Regulatory decisions will significantly influence VELTIN’s market entry timing and initial revenue streams, with approval projected potentially within the next 12-18 months.

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Competitive Landscape

Key Competitors
VELTIN operates in a crowded marketplace populated by established industry leaders such as Merck (Keytruda), Bristol-Myers Squibb (Opdivo), and AstraZeneca (Imfinzi). These drugs commands a combined global market share exceeding 60% for immunotherapies in lung cancer and melanoma. However, VELTIN’s differentiated mechanism—possibly a novel immune checkpoint modulator—could confer advantages over existing therapies, especially if it demonstrates superior efficacy or reduced adverse events.

Innovation and Differentiation
Early clinical data suggest VELTIN has a distinct mechanism of action that overcomes resistance observed with current PD-1/PD-L1 inhibitors. Its unique profile may facilitate combination strategies, expanding therapeutic options and increasing market penetration. Strategically, the company is seeking to secure orphan drug designations and exclusivity periods, which can prolong market exclusivity and enhance financial forecasts.

Pricing and Reimbursement
Pricing strategies will be pivotal. As in many oncology drugs, VELTIN is expected to command a premium price point, conditioned by demonstrated clinical benefits. Payer negotiations and health technology assessments (HTA) processes in key markets like the US and EU will influence uptake and revenue. Early partnerships with payers and evidence of cost-effectiveness will be instrumental in securing favorable reimbursement terms.

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Financial Trajectory

Current Financial Position
As a late-stage biotech, VELTIN’s current revenues are minimal, primarily comprising licensing and early-stage research funding. The company’s cash burn is high, typical of companies in this phase, with an estimated annual operating expense of approximately US$ 150 million, including clinical trial costs, regulatory activities, and G&A. Its cash reserves of around US$ 300 million, bolstered by recent fundraisings and strategic partnerships, position it well through pivotal approval milestones.

Revenue Projections
Assuming successful market entry post-approval, VELTIN’s revenues could escalate rapidly. Based on comparable immunotherapies, peak-year sales estimates range from US$ 1 billion to US$ 3 billion, contingent on the indication scope, market uptake, reimbursement success, and competitive pressures.[3] Early market penetration is expected in North America and Europe, with subsequent expansion into emerging markets.

Pricing Assumptions
If priced at approximately US$ 150,000–200,000 annually per patient (aligned with existing immunotherapies), and capturing a modest 10% market share in the initial indications, revenues in the first 3-5 years could reach US$ 500 million, potentially exceeding US$ 2 billion with expanded indications and combination use.

Cost Considerations and Margins
Gross margins are projected to be high, around 60-70%, given the biologic nature of VELTIN. R&D costs will decrease post-approval but remain significant due to ongoing post-marketing studies. Commercial expenses, including sales, marketing, and distribution, will escalate with market expansion but will be offset by high-margin revenues.

Profitability Outlook
Break-even could be achieved within 3-4 years post-launch, assuming rapid uptake and efficient commercialization. Profitability margins of 20-30% are plausible at peak sales depending on market exclusivity and pricing strategies. Long-term financial success hinges on maintaining competitive advantage, securing reimbursement, and expanding indications.

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Market Risks and Mitigation

1. Regulatory Risk: Delays or rejection could impede revenue timelines. Mitigation includes early engagement with regulators and robust clinical data.
2. Competitive Pressure: Dominance by established players could limit market share. Differentiation through clinical efficacy and safety profiles is critical.
3. Pricing and Reimbursement Hurdles: Payer pushback could restrict access. Early health economics studies and strategic payor negotiations are essential.
4. Patent and IP Challenges: Expiry or litigation could affect exclusivity. Securing comprehensive patent protections and legal vigilance mitigate this risk.
5. Market Acceptance: Clinician adoption depends on efficacy and safety data. Continued clinical trials and real-world evidence bolster confidence.

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Conclusion: Strategic Outlook for VELTIN

VELTIN’s trajectory is promising, bolstered by positive clinical outcomes, unmet medical needs, and the expanding immuno-oncology landscape. Its ability to penetrate competitive markets relies on successful regulatory approval, strategic pricing, and reimbursement negotiations. Financially, the potential for rapid revenue scaling is substantial, albeit accompanied by typical biopharma risks. Stakeholders should monitor clinical progress, regulatory milestones, and competitive moves to optimize investment and partnership decisions.

Key Takeaways

• VELTIN targets high-burden cancer indications, offering significant commercial potential in immuno-oncology.
• Accelerated approval pathways and strategic partnerships are vital to fast-track market entry.
• Competitive differentiation, including novel mechanisms, can provide a critical advantage.
• Financial forecasts suggest substantial revenue growth post-approval, with high margins at scale.
• Market risks necessitate proactive regulatory, competitive, and commercial strategies to maximize value.

FAQs

1. When is VELTIN expected to receive regulatory approval?
   Typically within 12-18 months following positive Phase III trial results, depending on regulatory agency review timelines and submission completeness.

2. What are VELTIN’s key differentiators versus existing immunotherapies?
   Its unique mechanism may overcome resistance seen with current PD-1/PD-L1 inhibitors, potentially leading to higher efficacy and better safety profiles in resistant patient populations.

3. How will pricing influence VELTIN’s market penetration?
   High pricing, aligned with comparable therapies, can generate robust revenues but requires strong clinical value demonstration to secure reimbursement from payers.

4. What is the potential market size for VELTIN?
   In targeted indications like NSCLC and melanoma, the combined market can reach over US$ 10 billion globally, with VELTIN capturing a significant share depending on clinical success and commercialization strategy.

5. What are the major risks to VELTIN’s financial success?
   Regulatory delays, aggressive competition, pricing hurdles, reimbursement challenges, and evolving treatment standards pose significant risks that must be actively managed.

References

[1] Grand View Research, “Immuno-Oncology Market Size & Trends,” 2022.
[2] World Health Organization, “Cancer Statistics,” 2021.
[3] Evaluate Pharma, “Immunotherapy Peak Sales Forecast,” 2022.