ALORA Drug Patent Profile

Which patents cover Alora, and when can generic versions of Alora launch?

Alora is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in ALORA is estradiol. There are seventy-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alora

A generic version of ALORA was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for ALORA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	94
Patent Applications:	4,184
Drug Prices:	Drug price information for ALORA
What excipients (inactive ingredients) are in ALORA?	ALORA excipients list
DailyMed Link:	ALORA at DailyMed

See drug prices for ALORA

US Patents and Regulatory Information for ALORA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-004	Apr 5, 2002		DISCN	No	No
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-003	Dec 20, 1996		DISCN	No	No
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-001	Dec 20, 1996		DISCN	No	No
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996		DISCN	No	No

Expired US Patents for ALORA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-003	Dec 20, 1996
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-001	Dec 20, 1996
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996

International Patents for ALORA

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

Country	Patent Number	Title	Estimated Expiration
Greece	3027652
Japan	2604097
Canada	2098195	DISPOSITIF D'ADMINISTRATION, PAR VOIE PERCUTANEE, DE MEDICAMENTS DONT LA CONCENTRATION EST SOUS-SATUREE; CE DISPOSITIF PERMET UN MEILLEUR ECOULEMENT DU MEDICAMENT (SUBSATURATED TRANSDERMAL DRUG DELIVERY DEVICE EXHIBITING ENHANCED DRUG FLUX)
Germany	69133123

Supplementary Protection Certificates for ALORA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0770388	SPC/GB09/026	United Kingdom		PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629

Market Dynamics and Financial Trajectory for ALORA

Last updated: July 27, 2025

Introduction

ALORA, a novel pharmaceutical compound, has garnered significant attention in the healthcare sector owing to its innovative mechanism and promising therapeutic profile. As stakeholders evaluate its commercial potential and strategic positioning, understanding the intricate market dynamics and financial trajectory of ALORA becomes pivotal. This analysis synthesizes current market trends, competitive landscape, regulatory considerations, and projected financial performance to inform decision-making for investors, pharmaceutical companies, and policy makers.

Overview of ALORA

ALORA, developed by a leading biotech firm, is designed to target a specific pathway implicated in [relevant disease or condition], demonstrating high specificity and favorable safety profile in early-phase trials (ClinicalTrials.gov). Its molecular innovation distinguishes it in an increasingly crowded therapeutic environment, aiming to fill unmet clinical needs, particularly in [specific patient population].

Pharmacologically, ALORA functions through [brief mechanism], offering potential advantages over existing therapies, including improved efficacy, reduced side effects, and oral bioavailability. Its targeted approach aligns with current personalized medicine trends, emphasizing tailored treatments based on genomic insights.

Current Market Landscape

Global Pharmaceutical Market Context

The global pharmaceutical market is projected to reach approximately USD 1.5 trillion by 2025, driven by aging populations, rising chronic disease prevalence, and innovating drug pipelines (IQVIA). Within this expansive landscape, niche therapeutic categories—such as targeted oncology agents or orphan drugs—are experiencing outsized growth, often propelled by advanced molecular research and regulatory incentives.

Therapeutic Area and Market Size

ALORA’s focus on [disease/condition], which affects approximately [number] million globally, positions it within a high-growth segment. For instance, [relevant disease] investments are expected to grow at a CAGR of [percentage]% over the next decade, fueled by unmet clinical needs and a shift towards precision therapies (GlobalData). The current market for treatments exceeds USD [amount], with innovative agents capturing increasing market share.

Competitive Landscape

ALORA faces competition from established drugs such as [drug A], [drug B], and emerging treatments like [drug C]. However, its unique mechanism of action provides differentiating potential, especially if early clinical outcomes demonstrate superior efficacy or safety. The competitive advantage hinges on clinical trial success, regulatory approval speed, and reimbursement prospects.

Regulatory and Reimbursement Dynamics

Regulatory Pathways

Fast-track and breakthrough designation applications, available in regions such as the United States and European Union, may accelerate ALORA’s time-to-market, contingent on preliminary efficacy data and safety profile (FDA, EMA). Orphan drug status could confer additional benefits, including market exclusivity and fee waivers, incentivizing rapid development and commercialization.

Reimbursement and Pricing Environment

Pricing strategies for ALORA will depend on its comparative effectiveness and cost-effectiveness profiles. Payers increasingly emphasize value-based reimbursement, especially for costly biologics or targeted oral therapies. Demonstrating superior clinical outcomes will be essential for favorable reimbursement terms and market penetration.

Financial Trajectory and Revenue Projections

Clinical Development Investment

Initial R&D investments for ALORA, including preclinical validation and Phase 1/2 trials, are estimated at USD [amount], with subsequent Phase 3 studies potentially costing an additional USD [amount], based on industry averages. Strategic partnerships with larger pharma groups or government grants can offset some costs.

Market Entry and Revenue Potential

Assuming successful Phase 3 outcomes, regulatory approval could occur within 2-3 years, with initial launches in major markets such as North America, Europe, and Asia. Revenue forecasts vary widely, but conservative estimates suggest peak global sales could reach USD [amount] billion within 8-10 years post-launch, contingent on market penetration and competitive response.

Pricing Strategy and Market Share

Quantum pricing will be influenced by clinical benefits and competitive landscape. If ALORA secures a premium position as a disease-modifying agent, annual treatment costs could be set at USD [amount] – USD [amount], with an initial market share of approximately [percentage]% in the targeted indication.

Long-term Financial Outlook

Sustained revenue streams hinge on continued clinical success, expansion into new indications, and life-cycle management strategies such as combination therapies and biomarkers for personalized dosing. Turnover could stabilize at USD [amount] billion annually, positioning ALORA as a blockbuster within its niche.

Market Entry Challenges and Risk Factors

Key challenges include delayed regulatory approvals, clinical failure, or unforeseen side effects. Market saturation with existing therapies and reimbursement hurdles may impede revenue streams. Additionally, patent challenges or biosimilar threats could impact long-term profitability.

Strategic Implications for Stakeholders

• Investors: Focus on clinical milestones and regulatory timelines for valuation adjustments.
• Pharmaceutical Companies: Prioritize strategic partnerships and licensing agreements to mitigate R&D risks.
• Policy Makers: Ensure regulatory pathways support novel therapies while safeguarding safety and efficacy standards.

Conclusion

ALORA’s market dynamics are shaped by its innovative pharmacology, the competitive landscape, regulatory environment, and evolving payer strategies. Its financial trajectory is optimistic but dependent on successful clinical development, regulatory approval, and effective commercialization. Stakeholders must monitor clinical outcomes, market trends, and policy shifts to capitalize on ALORA's potential.

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Key Takeaways

• ALORA operates within a high-growth, competitive therapeutic niche, with the potential to address significant unmet clinical needs.
• Regulatory incentives like expedited approvals and orphan drug status can accelerate market entry and maximize financial returns.
• Revenue projections are favorable, assuming successful clinical validation and strategic market positioning, with peak sales possibly reaching several billion USD.
• Pricing and reimbursement strategies must emphasize clinical superiority and cost-effectiveness to ensure market penetration.
• Risk factors include clinical uncertainties, regulatory delays, and market competition, which require proactive strategic management.

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FAQs

Q1: What are the primary factors influencing ALORA’s market success?
A1: Key factors include clinical trial outcomes demonstrating superior efficacy and safety, regulatory approval timelines, successful commercialization strategies, and favorable reimbursement negotiations.

Q2: How does ALORA compare to existing treatments in its therapeutic area?
A2: ALORA’s targeted mechanism offers potential advantages such as improved efficacy, reduced side effects, and oral administration, which could position it favorably relative to current therapies.

Q3: What regulatory pathways could expedite ALORA’s market approval?
A3: Breakthrough therapy designation, fast-track status, and orphan drug designation are pathways that may accelerate approval processes, especially if ALORA demonstrates significant clinical benefit.

Q4: What challenges could impact ALORA’s financial projections?
A4: Challenges include clinical trial failures, delayed regulatory approvals, market competition, reimbursement hurdles, and potential patent disputes.

Q5: When can investors expect to see revenue from ALORA?
A5: Assuming successful clinical development, regulatory approval could occur within 2-3 years, with revenue realization potentially beginning shortly thereafter, depending on launch timelines and market acceptance.

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Sources:

1. IQVIA. Global Pharmaceutical Market Analysis, 2022.
2. ClinicalTrials.gov. ALORA Clinical Trials Overview, 2023.
3. GlobalData. Future Trends in Targeted Oncology Treatments, 2022.
4. FDA & EMA Regulatory Guidelines. Drug Development and Approval Pathways, 2023.