SAVELLA Drug Patent Profile

When do Savella patents expire, 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^® Litigation and Generic Entry Outlook for Savella

A generic version of SAVELLA was approved as milnacipran hydrochloride by HETERO LABS LTD V on October 3^rd, 2024.

Summary for SAVELLA

International Patents:	33
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	27
Patent Applications:	434
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
University of Ottawa	Phase 4
Allergan	Phase 4
Alla Landa	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	AB	RX	Yes	No	7,994,220
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009	AB	RX	Yes	No	7,994,220
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	AB	RX	Yes	No	7,994,220
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-003	Jan 14, 2009	AB	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	6,602,911
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-001	Jan 14, 2009	7,888,342
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	7,888,342
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	6,992,110
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-004	Jan 14, 2009	6,992,110
Abbvie	SAVELLA	milnacipran hydrochloride	TABLET;ORAL	022256-002	Jan 14, 2009	6,602,911

International Patents for SAVELLA

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200803469	Milnacipran for the long-term treatment of fibromyalgia syndrome
World Intellectual Property Organization (WIPO)	2004009069
New Zealand	593199	Milnacipran for the long-term treatment of fybromyalgia syndrome
Brazil	PI0617541	uso de um medicamento e uso de pelo menos inibidor dual de recaptaÇço (dri)
China	1671368
European Patent Office	2322225	Inhibiteurs sélectifs de récaptage de la norépinéphrine et de la sérotonine utilisés dans le traitement du syndrome de la fibromyosite, de l'encéphalo-myélite myalgique et de la douleur (Selective norepinephrine serotonin reuptake inhibitors for treating fibromyalgia syndrome, chronic fatigue syndrome and pain)
Japan	2015134811	線維筋痛症候群の長期治療のためのミルナシプラン (MILNACIPRAN FOR LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME)

Market Dynamics and Financial Trajectory for Savella (Milnacipran)

Introduction to Savella

Savella, also known as milnacipran, is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) approved by the FDA for the management of fibromyalgia. It was approved on January 14, 2009, and released to the market on April 24, 2009, through a collaboration between Forest Laboratories and Cypress Bioscience[3].

Market Approval and Launch

Savella was positioned as a first-line treatment for fibromyalgia, marketed directly to physicians via sales representatives and professional journals. This strategic approach aimed to capitalize on the growing recognition and diagnosis of fibromyalgia[3].

Competitive Landscape

In the fibromyalgia drug market, Savella competes with other approved therapies such as Pfizer's Lyrica (pregabalin) and Eli Lilly/Boehringer Ingelheim's Cymbalta/Xeristar (duloxetine). These drugs have been key drivers of market growth, with Savella offering a unique mechanism of action (MOA) by having greater selectivity for blocking norepinephrine compared to Cymbalta[1][3].

Market Growth and Projections

The fibromyalgia drug market, driven by the sales of Lyrica, Cymbalta/Xeristar, and Savella, was expected to experience a 4.2% annual growth from 2009 to 2018. However, the market faced a significant decline from $1.8 billion in 2018 to $1.4 billion in 2019 due to the generic entry of pregabalin, a market-leading drug at the time[1].

Financial Performance

While specific financial data for Savella alone is not readily available, the overall performance of its parent companies and the broader fibromyalgia market provides insight into its financial trajectory.

• Revenue Contribution: As part of Forest Laboratories' portfolio, Savella contributed to the company's revenue stream. However, detailed financial figures specific to Savella are not isolated in publicly available reports.
• Market Share: Savella's market share was influenced by its competitors, particularly duloxetine, which was in close competition with pregabalin for market leadership in the United States. By 2015, duloxetine was expected to supplant pregabalin as the U.S. patient-share leader, although this did not necessarily translate to higher sales for Savella[1].

Marketing Strategy

Savella's marketing strategy focused on direct outreach to physicians and professional journals. This approach was designed to highlight Savella's clinical trial design, which required concurrent patient improvement on several dimensions, including pain, patient global assessment of change, and physical functioning. This strategy aimed to impress both doctors and patients with its comprehensive benefits beyond just pain management[3].

Clinical and Patient Impact

Savella's clinical trials demonstrated its efficacy in improving daily functioning in addition to pain management, which is a critical aspect for patients with fibromyalgia. The drug's unique MOA and clinical trial design were key selling points in its marketing campaign[3].

Adverse Reactions and Precautions

Like other SNRIs, Savella comes with a range of potential adverse reactions, including GI upset, headache, constipation, dizziness, and others. It also has specific contraindications and precautions, such as substantial alcohol abuse, chronic liver disease, and uncontrolled narrow-angle glaucoma. These factors can influence patient compliance and overall market performance[3].

Generic Competition and Market Impact

The entry of generic versions of leading fibromyalgia drugs significantly impacts the market. For instance, the generic erosion of pregabalin led to a sharp decline in the fibromyalgia drug market from 2018 to 2019. While Savella itself has faced generic competition, its unique MOA and clinical benefits continue to make it a viable option for some patients[1].

Future Outlook and Research

The fibromyalgia treatment market is expected to grow with the launch of novel drugs. Companies like Aptinyx Inc. are developing new treatments, such as NYX-2925, an NMDA receptor modulator, which showed positive results in clinical trials. This ongoing research and development activity suggests that the market will continue to evolve, potentially offering new opportunities for Savella and other existing treatments[4].

Key Takeaways

• Market Approval: Savella was approved in 2009 as a first-line treatment for fibromyalgia.
• Competitive Landscape: Savella competes with Lyrica and Cymbalta/Xeristar in the fibromyalgia market.
• Financial Performance: The market faced a decline due to generic competition, but Savella's unique MOA maintained its market presence.
• Marketing Strategy: Direct marketing to physicians and highlighting clinical trial benefits were key strategies.
• Clinical Impact: Savella improves daily functioning and pain management, critical for fibromyalgia patients.
• Future Outlook: Ongoing research and development in the fibromyalgia market may offer new opportunities.

FAQs

What is Savella used for?

Savella is used for the management of fibromyalgia, a chronic condition characterized by widespread pain and other symptoms.

When was Savella approved?

Savella was approved by the FDA on January 14, 2009, and released to the market on April 24, 2009.

How does Savella differ from other fibromyalgia treatments?

Savella has greater selectivity for blocking norepinephrine compared to other SNRIs like Cymbalta, offering a unique mechanism of action.

What are the common side effects of Savella?

Common side effects include GI upset, headache, constipation, dizziness, and others. It also has specific contraindications and precautions.

How has generic competition affected the fibromyalgia drug market?

Generic competition, particularly the entry of generic pregabalin, led to a sharp decline in the fibromyalgia drug market from 2018 to 2019.

What is the future outlook for the fibromyalgia treatment market?

The market is expected to grow with the launch of novel drugs and ongoing research and development activities.

Sources

1. Decision Resources, "Driven by Sales of Lyrica, Cymbalta/Xeristar and Savella, the Fibromyalgia Drug Market Will Experience 4.2 Percent Annual Growth," PR Newswire, September 8, 2010.
2. Allergan, "Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results," PR Newswire, January 7, 2019.
3. MM+M, "Savella," Medical Marketing and Media, April 24, 2009.
4. Coherent Market Insights, "Fibromyalgia Treatment Market, by Drug Class (Antidepressants (Milnacipran (Savella and Other Generics), Duloxetine (Cymbalta and Other Generics), and Others)," Market Research, 2022.
5. Allergan, "Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results," PR Newswire, February 10, 2020.

Last updated: 2024-12-16