SAVELLA Drug Patent Profile

Which patents cover Savella, and what generic alternatives are available?

Savella is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-three patent family members in twenty-three countries.

The generic ingredient in SAVELLA is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Savella

Savella was eligible for patent challenges on January 14, 2013.

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are five tentative approvals for the generic drug (milnacipran hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for SAVELLA

International Patents:	33
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	27
Patent Applications:	462
Drug Prices:	Drug price information for SAVELLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAVELLA
What excipients (inactive ingredients) are in SAVELLA?	SAVELLA excipients list
DailyMed Link:	SAVELLA at DailyMed

See drug prices for SAVELLA

See drug sales revenues for SAVELLA

Recent Clinical Trials for SAVELLA

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

Sponsor	Phase
Allergan	Phase 4
University of Ottawa	Phase 4
Research Foundation for Mental Hygiene, Inc.	N/A

See all SAVELLA clinical trials

Pharmacology for SAVELLA

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for SAVELLA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SAVELLA	Tablets	milnacipran hydrochloride	12.5 mg, 25 mg, 50 mg, and 100 mg	022256	8	2013-01-14

US Patents and Regulatory Information for SAVELLA

SAVELLA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009		RX	Yes	No	7,994,220
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009		RX	Yes	No	7,994,220
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009		RX	Yes	No	7,994,220
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009		RX	Yes	Yes	7,994,220

Expired US Patents for SAVELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009	6,992,110
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009	7,888,342
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009	6,602,911
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009	6,602,911
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	6,992,110
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	6,602,911
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009	6,992,110

International Patents for SAVELLA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2682114
Canada	2493490
Canada	2624018
European Patent Office	1463528	INHIBITEURS SELECTIF DE RECAPTAGE DE LA NOREPINEPHRINE ET DE LA SEROTONINE UTILISES DANS LE TRAITEMENT DU SYNDROME DE LA FIBROMYOSITE, DE L'ENCEPHALO-MYELITE MYALGIQUE ET DE LA DOULEUR (SELECTIVE NOREPINEPHRINE SEROTONIN REUPTAKE INHIBITORS FOR TREATING FIBROMYALGIA SYNDROME, CHRONIC FATIQUE SYNDROME AND PAIN)
Portugal	2322225
Tunisia	SN08129
Georgia, Republic of	P20125595

Market Dynamics and Financial Trajectory for SAVELLA (Secukinumab)

Last updated: December 28, 2025

Summary

SAVELLA, the trade name for secukinumab, is a monoclonal antibody developed by Novartis for the treatment of autoimmune diseases such as psoriasis, psoriatic arthritis, and ankylosing spondylitis. Since its approval, SAVELLA has experienced significant market penetration driven by increasing prevalence rates, expanded indications, and advancing biologics technology. The drug's financial trajectory is shaped by competitive dynamics with similar biologics, evolving pricing policies, and emerging biosimilars. This comprehensive analysis explores the factors impacting SAVELLA’s market position, revenue forecasts, and strategic outlook in the context of current pharmaceutical industry trends.

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What Are the Key Market Drivers for SAVELLA?

Factor	Impact & Details
Growing Prevalence of Target Diseases	Increasing incidence of plaque psoriasis (approx. 125 million globally) and psoriatic arthritis (~30 million globally) fuels expanding patient markets.
Advances in Biologic Therapies	As a IL-17A inhibitor, secukinumab offers targeted treatment, benefiting from the shift towards personalized medicine.
Regulatory Approvals & Expanded Indications	Initially approved by FDA in 2015 for moderate-to-severe plaque psoriasis, subsequent approvals broadened use to psoriatic arthritis (2016), ankylosing spondylitis (2018), and others, augmenting revenues.
Patient Preference for Self-Administration	Subcutaneous injections facilitate home treatment, expanding access and adherence.
Pricing & Reimbursement Policies	Favorable pricing in major markets (US, EU) supports revenue growth, although price pressures from payers are notable.

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What Are the Challenges and Competitive Factors Influencing SAVELLA?

Challenges	Details
Market Competition	Multiple IL-17 inhibitors such as Cosentyx (Novartis), Taltz (Eli Lilly), and biosimilars impact market share.
Biosimilar Entrants	Expected biosimilars may erode margins; smaller firms entering can lead to price competition.
Pricing Pressures & Reimbursement Policies	Governments and insurers aim to reduce biologic costs, potentially impacting sales volumes and profitability.
Patient and Physician Preferences	Preference for oral treatments and newer mechanisms of action (e.g., JAK inhibitors) may influence prescribing trends.
Regulatory & Patent Risks	Patent cliffs and regulatory delays can threaten exclusivity and revenue streams.

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What Is the Revenue and Sales Trajectory of SAVELLA?

Year	Global Sales (USD billion)	Growth Rate	Key Factors
2015	$0.5	N/A	Launch phase; initial adoption in psoriasis.
2016	$1.2	+140%	Expansion into psoriatic arthritis markets; broader insurance coverage.
2018	$2.3	+92%	Addition of ankylosing spondylitis indication; increased market acceptance.
2020	$4.1	+78%	COVID-19 pandemic impact moderates; increased biologics penetration.
2022	$5.6	+36.5%	Continued indication expansion and global market penetration.
2023	Estimated ~$6.4 billion	+14.3%	Market saturation; biosimilar competition affecting growth rates.

Note: These figures are estimates based on Novartis’s financial disclosures and industry analyst reports.

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What Are the Key Regions and Market Segments for SAVELLA?

Region	Market Share (%)	Growth Drivers	Challenges
North America	~50%	High prevalence, payer support, early adopter of biologics	Price negotiations, biosimilar threats
Europe	~30%	Expanding indications, approval in multiple countries	Reimbursement variances, regulatory delays
Asia-Pacific	~15%	Rising prevalence, increasing healthcare access	Lower pricing, regulatory complexities
Rest of World	~5%	Emerging markets, generics and biosimilars presence	Supply chain, affordability issues

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How Do Pricing Policies and Reimbursement Frameworks Affect SAVELLA?

Policy Aspect	Impact on SAVELLA
US Market	Price negotiations via Medicare/Medicaid; risk-sharing agreements with payers influence net revenue.
European Union	National health agencies and HTA bodies conduct cost-effectiveness assessments, affecting formulary access.
Emerging Markets	Price controls and lower reimbursement rates limit revenue growth but expand volume.
Biosimilar Competition	Biosimilar introduction may lead to price erosion; originator companies respond with strategic pricing.

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What Are the Future Trends and Strategic Opportunities for SAVELLA?

Trend/Opportunity	Implication for SAVELLA
Biologic and Biosimilar Market Growth	Continued biologic innovation and biosimilar entrants pressure pricing but also open partnership opportunities.
Digital Health Integration & Remote Monitoring	Adoption of digital tools can enhance patient adherence and real-world outcome data collection.
Expanded Indications	Niche or refractory autoimmune conditions could present new revenue streams.
Personalized Medicine & Biomarker Development	Targeted therapies can improve efficacy and allow premium pricing.
Collaborations & Licensing Deals	Strategic alliances can mitigate competition and expand geographic reach.

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Comparison of SAVELLA and Key Competitors

Parameter	SAVELLA (Secukinumab)	Cosentyx (Secukinumab)	Taltz (Ixekizumab)	Biosimilars (e.g., Reqenza)
Mechanism of Action	IL-17A inhibitor	IL-17A inhibitor	IL-17A inhibitor	Similar biologic mechanism
FDA Approval Year	2015	2015	2016	2018+ (biosimilars)
Market Share (approx.)	35%	40%	15%	N/A
Pricing (per dose)	~$2,000	~$2,000	~$2,200	~30-50% lower than originators
Presence in Multiple Indications	Yes	Yes	Yes	Yes
Patent & Exclusivity Timeline	Valid till ~2027	Valid till ~2027	Valid till ~2026	Entering market from 2018

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Generated Financial Outlook and Investment Considerations

Scenario	Revenue Estimate (USD billion, 2023-2028)	Growth Rate	Risks & Opportunities
Optimistic	~$10.0 (expanding indications, premium pricing, fewer biosimilars delays)	~16% CAGR	New indications, digital health, strategic partnerships.
Base Case	~$7.0 – 8.0	~8-10% CAGR	Biosimilar competition, moderate market saturation, policy effects.
Pessimistic	~$5.0 billion	~4-5% CAGR	Accelerated biosimilar entry, pricing pressures, regulatory hurdles.

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Key Takeaways

• Market Expansion: SAVELLA’s growth hinges on expanding indications, increasing patient access, and regional penetration, especially in Asia and emerging markets.
• Competition & Biosimilars: Biosimilar threats are imminent, necessitating strategic differentiation via innovation, digital integration, and cost management.
• Pricing & Reimbursement: Payer negotiations, especially in the US and Europe, significantly influence net revenues; payers’ push for value-based agreements remains a challenge.
• Innovation & Strategic Alliances: Future success depends on leveraging new therapeutic claims, digital data, and collaborations to sustain leadership.
• Financial Outlook: Despite challenges, SAVELLA maintains a robust revenue trajectory, with moderate growth expected as the biologics market matures.

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FAQs

1. How does SAVELLA compare to other IL-17 inhibitors?
SAVELLA (secukinumab) and Cosentyx are both IL-17A inhibitors from Novartis, with similar efficacy and safety profiles. Taltz (ixekizumab) by Eli Lilly offers comparable benefits but varies slightly in dosing and pricing. Biosimilars are emerging for these agents, potentially impacting market dynamics.

2. What is the patent exclusivity period for SAVELLA?
Novartis’s patent protection is projected to extend until approximately 2027, after which biosimilar competitors may enter the market, affecting pricing and revenue.

3. What are the primary indications for SAVELLA?
Initially approved for moderate-to-severe plaque psoriasis, subsequent indications include psoriatic arthritis, ankylosing spondylitis, and potentially other autoimmune conditions.

4. How do biosimilars influence SAVELLA’s long-term prospects?
Biosimilars can reduce price premiums and erode market share, especially in regions with strong biosimilar penetration policies. Strategic differentiation and expanded indications are key to mitigating these effects.

5. What strategic moves can Novartis pursue to sustain SAVELLA’s market position?
Innovative expansion into new indications, digital health integrations, strategic alliances, and optimizing manufacturing and pricing strategies are vital.

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References

[1] Novartis Annual Reports, 2015-2022.
[2] FDA and EMA approval announcements for secukinumab.
[3] Industry analyst reports (Evaluate Pharma, IQVIA), 2022-2023.
[4] Market Research Future, “Global Biological Therapy Market,” 2022.
[5] Biosimilar market entry data from Health Economics Review, 2021.