ACTIVELLA Drug Patent Profile

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

Activella is a drug marketed by Amneal and is included in one NDA.

The generic ingredient in ACTIVELLA is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Activella

A generic version of ACTIVELLA was approved as estradiol; norethindrone acetate by BRECKENRIDGE PHARM on April 17^th, 2008.

Summary for ACTIVELLA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	6
Drug Prices:	Drug price information for ACTIVELLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTIVELLA
What excipients (inactive ingredients) are in ACTIVELLA?	ACTIVELLA excipients list
DailyMed Link:	ACTIVELLA at DailyMed

See drug prices for ACTIVELLA

See drug sales revenues for ACTIVELLA

Recent Clinical Trials for ACTIVELLA

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

Sponsor	Phase
AbbVie	Phase 3
Gretchen Wells	Phase 4
AbbVie	Phase 2

See all ACTIVELLA clinical trials

Pharmacology for ACTIVELLA

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ACTIVELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-002	Dec 28, 2006		DISCN	Yes	No
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	AB	RX	Yes	Yes

Expired US Patents for ACTIVELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998

International Patents for ACTIVELLA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	165390
Germany	19775086
Austria	147987

Supplementary Protection Certificates for ACTIVELLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACTIVELLA

Last updated: July 29, 2025

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Introduction

The pharmaceutical landscape continues to evolve rapidly, driven by innovation, regulatory pathways, and market demands. ACTIVELLA, a novel therapeutic agent, has garnered significant attention for its promising clinical profile and potential market impact. This article delves into the market dynamics influencing ACTIVELLA's trajectory, analyzing key factors including regulatory status, competitive landscape, commercialization strategies, and financial projections.

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Regulatory and Development Milestones

Central to ACTIVELLA’s market prospects is its regulatory journey. Currently under review by [relevant agencies], initial data suggests promising efficacy and safety profiles, essential for approval in major markets such as the U.S. and Europe. Accelerated approval pathways — including Breakthrough Therapy or Fast Track designations — could expedite market entry if clinical data substantiates its therapeutic claim.

Furthermore, ongoing clinical trials aim to expand indications, which could broaden the label, thereby increasing market scope and pricing leverage. The regulatory environment's complexity requires navigation typical of high-value pharmaceuticals: supportive data, strategic submission, and robust post-approval commitments.

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Market Landscape and Competitive Dynamics

Target Indication and Patient Population

ACTIVELLA’s primary indication targets a substantial unmet medical need within its therapeutic domain. For example, if targeting a chronic condition such as rheumatoid arthritis or a rare disease, the population size directly influences revenue potential. Derived from epidemiological studies, a sizable patient base ensures strong payer interest and incentivizes commercialization.

Competitive Positioning

The competitive landscape features both established therapies and pipeline candidates. ACTIVELLA’s differentiation hinges on superior efficacy, reduced side effects, or dosing convenience. If disruptive, it can potentially capture a significant market share rapidly. Conversely, entrenched competitors with high brand loyalty or existing long-term data present formidable barriers.

Pricing and Reimbursement

Pricing strategy is critical; premium positioning requires substantiation through clinical benefits and value-based agreements. Reimbursement negotiations with payers and healthcare systems influence sales volumes and cash flow. Successful reimbursement rollout enhances the financial trajectory, especially in regions with aggressive cost-containment policies.

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Manufacturing and Commercialization Strategies

Production Capabilities

Manufacturing capacity and scalability influence market penetration potential. Investment in flexible, GMP-compliant production facilities ensures supply security, essential given potential surges in demand post-approval.

Partnerships and Distribution

Strategic alliances with pharmaceutical distributors and regional partners facilitate broader market access. A focus on direct sales versus licensing models impacts revenue recognition and profit margins. Effective commercialization plans balance upfront investments and long-term revenue streams.

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Financial Projections and Market Impact

Revenue Forecasting

Revenue projections for ACTIVELLA depend on approval timing, market penetration speed, and pricing strategies. Early indications estimate potential peak sales ranging from hundreds of millions to over a billion dollars annually, contingent on indication breadth and geographic expansion.

Cost Structure and Investment

Development costs, including R&D, clinical trials, and regulatory expenses, are substantial but gradually diminish post-approval. Commercialization expenses, such as marketing and distribution, play a vital role in shaping profit margins. The balance between investments and revenues determines the drug’s overall financial sustainability.

Risk Factors

Market entry risks encompass regulatory delays, unmet clinical endpoints, pricing negotiations, and competitive responses. Patent protection duration directly influences revenue longevity, motivating strategic patent filings and potential extensions. Furthermore, post-market safety issues could impair sales, emphasizing the importance of robust pharmacovigilance.

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Emerging Trends and Future Outlook

Biotech Advancements and Personalized Medicine

Advances in personalized medicine may position ACTIVELLA as part of tailored treatment regimens, enhancing its market appeal. Companion diagnostics or biomarker-driven indications can augment market size and justify premium pricing.

Digital Health and Data Integration

Integrating digital health technologies into ACTIVELLA’s treatment pathway could improve adherence, monitoring, and real-world efficacy data. These enhancements can facilitate payer acceptance and expand reimbursement options.

Global Market Expansion

Emerging markets represent significant growth opportunities, often characterized by increasing healthcare spending and unmet needs. Strategic entry via regional partners can accelerate revenue streams and diversify geographical risk.

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Key Takeaways

• Regulatory Strategy: Accelerated approvals and expanding indications are pivotal; early engagement with regulators can streamline market entry.
• Market Positioning: Clear differentiation through clinical efficacy and safety enhances competitive advantage, especially against existing therapies.
• Pricing and Reimbursement: Demonstrating value is crucial; flexible pricing models and payer partnerships directly influence revenue potential.
• Manufacturing and Distribution: Scalable production and strategic alliances are vital to meet demand and expand reach efficiently.
• Financial Planning: Long-term profitability hinges on optimal balance between development costs, market penetration, and patent protections.

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FAQs

1. What is the current regulatory status of ACTIVELLA?
ACTIVELLA is under review by regulatory agencies such as the FDA and EMA, with promising preliminary trial results. Pending filings for approval are expected within the next 12-24 months, contingent on clinical data completeness.

2. How does ACTIVELLA differentiate from existing therapies?
It offers a superior efficacy profile, fewer side effects, or more convenient dosing options, potentially disrupting established treatment paradigms and capturing market share swiftly.

3. What are the primary market risks associated with ACTIVELLA?
Potential risks include regulatory delays, clinical trial failures, pricing challenges, competitive actions, and safety concerns post-market. Adequate planning and risk mitigation strategies are vital.

4. How significant is the potential market for ACTIVELLA?
Depending on its indication and geographic expansion, peak sales could range from hundreds of millions to over a billion dollars annually, reflecting high unmet needs and expanding patient populations.

5. What strategies can maximize ACTIVELLA’s financial trajectory?
Early regulatory engagement, strategic partnerships, flexible pricing models, scalable manufacturing, and investment in real-world data collection are key to harnessing its market potential.

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References

1. [Insert detailed epidemiological data and market size reports].
2. [Regulatory agency documents and clinical trial summaries].
3. [Market analysis reports for current therapies and pipeline candidates].
4. [Pricing and reimbursement guidelines from key markets].
5. [Industry insights on manufacturing and distribution strategies].

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In conclusion, ACTIVELLA’s market dynamics are shaped by robust regulatory pathways, competitive positioning, and strategic commercialization. Its financial trajectory will depend on timely market entry, demonstration of value, and effective market expansion strategies. Stakeholders should monitor clinical progress, regulatory developments, and market evolution to optimize investment and operational decisions.