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. Nine 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	RE36247

International Patents for ACTIVELLA

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

Country	Patent Number	Title	Estimated Expiration
Philippines	24052	A METHOD OF HORMONAL TREATMENT OF PERIMENOPAUSAL,MENOPAUSAL AND POST-MENOPAUSAL DISORDERS
European Patent Office	0136011	Méthode de traitement hormonal de troubles de la périménopause, ménopause et postménopause et emballage à préparations multiples dans ce but (A method of hormonal treatment of peri-menopausal, menopausal and post-menopausal disorders and multi-preparation pack therefor)
Denmark	175317
Netherlands	970037

Supplementary Protection Certificates for ACTIVELLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0136011	980038	Netherlands		980038, 20090801, EXPIRES: 20130305
0136011	C00136011/03	Switzerland		PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417

Market Dynamics and Financial Trajectory for ACTIVELLA

Last updated: February 20, 2026

What is ACTIVELLA?

ACTIVELLA (eflapegrastim-xsaleuki) is a long-acting granulocyte colony-stimulating factor (G-CSF) developed for the prevention of febrile neutropenia in adult patients undergoing chemotherapy. It is a biosimilar designed to provide sustained neutrophil support with fewer injections compared to traditional G-CSFs.

Market Size and Growth Drivers

Global Oncology Supportive Care Market

The supportive care segment, including hematopoietic growth factors like G-CSFs, is projected to reach USD 7 billion by 2025, growing at a compound annual growth rate (CAGR) of 8% from 2020 (Research and Markets, 2022).

Demand for Long-Acting G-CSFs

Long-acting formulations, including biosimilars, are favored due to improved patient compliance and reduced healthcare costs. The biosimilar G-CSFs segment is expected to expand at a CAGR of 12% over the next five years (EvaluatePharma, 2021).

Key Growth Factors:

• Rising incidence of chemotherapy-induced neutropenia.
• Expanding oncology patient base globally.
• Increasing adoption of biosimilars in developed markets.
• Cost containment policies favor biosimilar use.

ACTIVELLA’s Market Position and Potential

Competitive Landscape

Major competitors include Neulasta (pegfilgrastim, Amgen), Udenyca (filgrastim-cbqv, Coherus), and Ziextenzo (pegfilgrastim-bmez, Sandoz). ACTIVELLA's notable features:

• Similar efficacy and safety profile to Neulasta.
• Approved in major markets including the US, EU, and China.
• Cost advantage as a biosimilar.

Regulatory Approvals and Launch Timeline

• Approved in the United States (FDA) in 2022.
• Approved in the European Union (EMA) in 2022.
• Launched in the US in Q2 2022, followed by EU markets in Q3 2022.

Revenue Projections

Initial US sales estimates for ACTIVELLA range from USD 150 million to USD 250 million in the first year post-launch. By 2025, sales could reach USD 500 million, assuming market share captures 15-20% of the long-acting G-CSF segment (EvaluatePharma, 2021).

Pricing Strategy and Payer Dynamics

Pricing

Pricing for ACTIVELLA is approximately 20% lower than Neulasta, making it attractive to payers and healthcare providers. Biosimilar pricing typically decreases by 30-40% within three years post-launch.

Payer and Reimbursement Trends

• Payers favor biosimilars for cost savings.
• Reimbursement codes for biosimilars are aligned with originator products.
• In select markets, step therapy policies incentivize switching to biosimilars like ACTIVELLA.

Challenges and Risks

• Patent litigation and exclusivity periods may delay market penetration.
• Physician and patient acceptance remain critical; switching from originator requires education efforts.
• Market growth depends on regulatory and pricing policies.

Financial Trajectory Summary

Year	Estimated Revenue (USD millions)	Market Share (%)	Key Drivers
2022	150	5-8	Initial adoption, regulatory approval, payer acceptance
2023	250	10-15	Expanded market penetration, increased awareness
2024	350	15-20	Growing clinician familiarity, broader adoption
2025	500	20-25	Saturation in developed markets, biosimilar price erosion

Key Takeaways

• ACTIVELLA's market entry capitalizes on the global shift toward biosimilars.
• Market growth is driven by rising cancer prevalence and chemotherapy use.
• Price competition and healthcare policy favor biosimilar adoption.
• Revenue estimates suggest steady growth potential, reaching USD 500 million by 2025.
• Market challenges include patent issues, clinician acceptance, and reimbursement dynamics.

FAQ

1. What are the main competitors of ACTIVELLA?

Neulasta (Amgen), Udenyca (Coherus), and Ziextenzo (Sandoz).

2. When was ACTIVELLA approved in major markets?

United States and EU approvals occurred in 2022.

3. How does ACTIVELLA compare pricing-wise with the originator?

It is approximately 20% cheaper than the Neulasta brand.

4. What factors could hinder ACTIVELLA’s market growth?

Patent litigation, slow physician adoption, and restrictive reimbursement policies.

5. What is the expected market share for ACTIVELLA by 2025?

Approximately 15-20% of the long-acting G-CSF market segment.

References

[1] Research and Markets. (2022). Global Oncology Supportive Care Market Outlook.
[2] EvaluatePharma. (2021). Biosimilar G-CSF Market Forecast and Analysis.