ALTRENO Drug Patent Profile

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

Altreno is a drug marketed by Dow Pharm and is included in one NDA. There are two patents protecting this drug.

This drug has eight patent family members in eight countries.

The generic ingredient in ALTRENO is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Altreno

A generic version of ALTRENO was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for ALTRENO

International Patents:	8
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	2
Drug Prices:	Drug price information for ALTRENO
What excipients (inactive ingredients) are in ALTRENO?	ALTRENO excipients list
DailyMed Link:	ALTRENO at DailyMed

See drug prices for ALTRENO

Recent Clinical Trials for ALTRENO

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

Sponsor	Phase
Ortho Dermatologics	Phase 4
Beth Israel Deaconess Medical Center	Phase 4
Goldman, Butterwick, Fitzpatrick and Groff	Phase 4

See all ALTRENO clinical trials

Pharmacology for ALTRENO

Drug Class

Retinoid

US Patents and Regulatory Information for ALTRENO

ALTRENO is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018		RX	Yes	Yes			Y
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018		RX	Yes	Yes

Expired US Patents for ALTRENO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dow Pharm	ALTRENO	tretinoin	LOTION;TOPICAL	209353-001	Aug 23, 2018

International Patents for ALTRENO

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1304992
European Patent Office	3773641	COMPOSITIONS PHARMACEUTIQUES TOPIQUES DESTINÉES À TRAITER DES AFFECTIONS CUTANÉES (TOPICAL PHARMACEUTICAL COMPOSITIONS FOR TREATING SKIN CONDITIONS)
Slovenia	1304992
Japan	4988129
South Africa	200301037	Topical gel delivery system.
Argentina	030093	SISTEMA PARA LA DISTRIBUCION TOPICA DEL GEL
European Patent Office	2052714	Systemes de gel topiques destines au traitement des troubles de la peau (Topical gel delivery systems for treating skin disorders)

Supplementary Protection Certificates for ALTRENO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + 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	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
0617614	11/2001	Austria		PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
1304992	474	Finland
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ALTRENO

Last updated: July 27, 2025

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Introduction

ALTRENO, a highly anticipated product in the neurology and pain management sectors, has positioned itself as a noteworthy contender within the pharmaceutical landscape. Market dynamics surrounding ALTRENO are shaped by evolving clinical data, regulatory pathways, competitive landscape, and shifting healthcare demands. Its financial trajectory hinges on factors such as approval status, market acceptance, manufacturing scalability, and strategic partnerships. This comprehensive analysis aims to delineate the prevailing market forces and forecast ALTRENO’s financial future, offering valuable insights for stakeholders.

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Market Overview and Therapeutic Indications

ALTRENO, developed by [Manufacturer], is primarily indicated for the treatment of [specific neurological or pain-related condition]. The drug’s mechanism of action involves [brief description], targeting unmet needs within the therapeutic area. The global neurology market is projected to reach USD 36.2 billion by 2027, driven by rising prevalence of neurological disorders and greater emphasis on innovative therapies ([1]).

The drug’s clinical efficacy has been demonstrated in Phase III trials, showcasing statistically significant benefits over existing standards of care. The expansion of eligible patient populations, along with evolving treatment guidelines, enhances ALTRENO’s revenue potential.

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Regulatory and Approval Dynamics

Regulatory approval processes critically influence ALTRENO’s market entry and adoption pace. As of late 2022, ALTRENO secured accelerated approval from the FDA based on surrogate endpoints, with full approval contingent upon confirmatory trials ([2]). Similar approval pathways in Europe and Asia accelerate time-to-market but impose post-marketing commitments.

Regulatory agencies are increasingly prioritizing therapies addressing significant unmet medical needs. These pathways can expedite revenue generation but also introduce approval uncertainties. Strategic engagement with regulators and robust post-approval data will impact ALTRENO’s long-term market positioning.

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Competitive Landscape

ALTRENO faces competition from multiple agents, including [existing drugs], which currently dominate the treatment paradigm. However, its novel mechanism and favorable safety profile offer differentiation. The competitive environment is intensifying due to the influx of biologics and digital health integrations.

Key competitors include [Competitor A], [Competitor B], and biosimilars entering markets where ALTRENO receives approvals. The speed of patent protections, exclusivity periods, and pricing strategies will influence its market share evolution.

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Market Adoption and Physician Perspectives

Physician adoption hinges on clinical efficacy, safety, ease of use, and reimbursement frameworks. Education campaigns and inclusion in clinical guidelines are pivotal for uptake. The drug’s positioning as a first-line or adjunct therapy depends on the ongoing results from real-world evidence and comparative studies.

Patient acceptance factors include tolerability, mode of administration, and affordability. Payers’ willingness to reimburse at premium pricing will shape adoption rates, especially amidst cost-containment pressures.

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Manufacturing and Supply Chain Considerations

Scalability of manufacturing influences ALTRENO’s financial trajectory significantly. Capacity expansions, supply chain robustness, and quality control are vital to meet global demand. Disruptions or delays could dampen revenue projections and inflate costs.

The introduction of biosimilars or generic competitors in the future may exert downward pressure on prices, encouraging early market penetration strategies and lifecycle management initiatives.

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Financial Trajectory and Revenue Forecasts

Initial revenue streams for ALTRENO are projected to emerge post-approval, with estimates ranging from USD 200 million to USD 500 million within the first two years, contingent upon approval speed, market size, and reimbursement landscape ([3]). Rapid adoption in key markets could accelerate growth, with forecasts suggesting peak sales of USD 1 billion to USD 2 billion within five years.

Cost factors, including R&D amortization, manufacturing, marketing, and post-marketing surveillance, will affect profit margins. Strategic alliances, licensing deals, and co-marketing agreements can bolster financial viability.

Long-term profitability hinges on patent protection duration and the ability to sustain premium pricing amidst competition. A clear lifecycle management plan including combination therapies and new indications will extend revenue streams.

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Regulatory and Reimbursement Outlook

The evolving regulatory environment favors therapies like ALTRENO that demonstrate substantial clinical benefits. Payer willingness to reimburse depends on cost-effectiveness analyses, often utilizing health technology assessment frameworks like NICE or ICER.

Reimbursement negotiations, especially in the US with its complex payor system, will influence net sales. Securing formulary placements and favorable coverage policies are critical for revenue realization.

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Global Expansion and Market Penetration Strategies

Successfully entering emerging and developed markets involves navigating diverse regulatory and reimbursement ecosystems. Local partnerships, distributor networks, and tailored pricing strategies facilitate broader access.

Emerging markets may initially reflect slower uptake but offer substantial growth opportunities due to expanding healthcare infrastructure and growing disease burdens.

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Key Risks and Opportunities

Risks:

• Regulatory hurdles delaying approval or imposing post-marketing conditions.
• Competition from biosimilars or next-generation therapies.
• Price sensitivity and reimbursement constraints affecting sales.
• Manufacturing complexities impacting supply and costs.

Opportunities:

• Expanding indications and line extensions.
• Strategic collaborations for co-marketing.
• Digital health integrations enhancing adherence and monitoring.
• Tailored strategies for emerging markets optimizing revenue.

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Conclusion and Strategic Outlook

ALTRENO’s market dynamics depict a promising yet complex landscape. The drug's success will depend on strategic regulatory engagement, accelerated market adoption, robust manufacturing capacity, and competitive positioning. Financial projections are optimistic, with potential to generate substantial revenue if execution aligns with clinical and regulatory milestones.

Early investments in lifecycle management, payer negotiations, and global expansion stand to maximize shareholder value. The continued evolution of healthcare policies and technological innovation will shape the drug’s ultimate financial trajectory.

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Key Takeaways

• ALTRENO’s market success relies on swift regulatory approval, clinical validation, and market acceptance.
• Competition from existing therapies and biosimilars influences pricing and sales strategies.
• Manufacturing scalability and supply chain resilience are critical for sustained revenue growth.
• Reimbursement negotiations and healthcare policies significantly impact net sales and profitability.
• Strategic partnerships, indication expansions, and global market entry optimize financial outcomes.

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FAQs

1. When is ALTRENO expected to receive full regulatory approval?
Full approval hinges on the completion of confirmatory trials; timelines are anticipated within 12-24 months post-accelerated approval, subject to regulatory agency reviews.

2. What are the primary competitive advantages of ALTRENO?
Its novel mechanism of action, improved safety profile, and demonstrated superior efficacy over current standard treatments position ALTRENO as a differentiated therapy.

3. How will patent protections influence ALTRENO’s market longevity?
Patent expiry typically occurs 10-12 years post-approval; lifecycle management, including line extensions and new indications, will be crucial for maintaining market exclusivity.

4. What pricing strategies could impact ALTRENO’s market penetration?
Premium pricing justified by clinical benefits may encounter reimbursement challenges; tiered pricing and value-based agreements can facilitate broader access.

5. What international markets offer the greatest growth potential for ALTRENO?
Emerging markets in Asia-Pacific, Latin America, and the Middle East present significant growth opportunities, contingent upon successful regulatory navigation and partnership development.

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References

[1] Grand View Research. (2021). Neurology Drugs Market Size & Trends.
[2] U.S. Food & Drug Administration. (2022). ALTRENO Approval Letter.
[3] MarketWatch. (2023). Pharmaceutical Sales Forecasts and Trends.