CYMBALTA Drug Patent Profile

When do Cymbalta patents expire, and what generic alternatives are available?

Cymbalta is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in CYMBALTA is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cymbalta

A generic version of CYMBALTA was approved as duloxetine hydrochloride by AUROBINDO PHARMA LTD on December 11^th, 2013.

Summary for CYMBALTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	147
Patent Applications:	4,690
Drug Prices:	Drug price information for CYMBALTA
Drug Sales Revenues:	Drug sales revenues for CYMBALTA
What excipients (inactive ingredients) are in CYMBALTA?	CYMBALTA excipients list
DailyMed Link:	CYMBALTA at DailyMed

See drug prices for CYMBALTA

See drug sales revenues for CYMBALTA

Recent Clinical Trials for CYMBALTA

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

Sponsor	Phase
National Cancer Institute, Egypt	Phase 4
Ain Shams University	Phase 4
Grünenthal GmbH	Phase 3

See all CYMBALTA clinical trials

Pharmacology for CYMBALTA

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

Paragraph IV (Patent) Challenges for CYMBALTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CYMBALTA	Delayed-release Capsules	duloxetine hydrochloride	40 mg	021427	1	2012-05-10
CYMBALTA	Delayed-release Capsules	duloxetine hydrochloride	20 mg, 30 mg and 60 mg	021427	16	2008-08-04

US Patents and Regulatory Information for CYMBALTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-001	Aug 3, 2004	AB	RX	Yes	No
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-002	Aug 3, 2004	AB	RX	Yes	No
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004	AB	RX	Yes	Yes

Expired US Patents for CYMBALTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004	6,596,756*PED
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-001	Aug 3, 2004	5,023,269*PED
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004	5,508,276*PED
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-002	Aug 3, 2004	6,596,756*PED
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-002	Aug 3, 2004	5,023,269*PED
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-001	Aug 3, 2004	5,508,276*PED

International Patents for CYMBALTA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	9913671
Greece	3001207
Israel	84863	3-ARYLOXY-3-SUBSTITUTED PROPANAMINES,PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM
Portugal	693282
Slovenia	1113797
U.S.S.R.	1598865	CПOCOБ ПOЛУЧEHИЯ 3-APИЛOKCИ-3-ЗAMEЩEHHЫX ПPOПAHAMИHOB ИЛИ ИX ФAPMAKOЛOГИЧECKИ ПPИEMЛEMЫX KИCЛOTHO-AДДИTИBHЫX COЛEЙ (METHOD OF PRODUCING 3-ARYLOXY-3-SUBSTITUTED PROPANE AMINES OR THEIR PHARMACEUTICALLY ACCEPTABLE ACID-ADDITIVE SALTS)

Supplementary Protection Certificates for CYMBALTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273658	3/2005	Austria		PRODUCT NAME: 3-ARYLOXY-3-SUBSTITUIERTE-PROPANAMINE; REGISTRATION NO/DATE: EU/1/04/280/001 - EU/1/04/280/006 20040811
0273658	300171	Netherlands		300171, 20071218, EXPIRES: 20121217
0273658	C00273658/01	Switzerland		PRODUCT: DULOXETIN; REG. NO/DATE: SWISSMEDIC 56727 20041217; DER WIDERRUF VOM 05.03.2009 ERFOLGTE IRRTUEMLICH
0273658	C300171	Netherlands		PRODUCT NAME: DULOXETINE EN FARMACEUTISCH AANVAARDBARE ZUURADDITIEZOUTEN DAARVAN, EN IN HET BIJZONDER DULOXETINE HYDROCHLORIDE; NATL REGISTRATION NO/DATE: EU/1/04/280/001-006 20040811
0693282	PA2005001	Lithuania		PRODUCT NAME: DULOXETINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/04/280/001, EU/1/04/280/002, EU/1/04/280/003, EU/1/04/280/004, EU/1/04/280/005, EU/1/04/280/006 20040811
0693282	PA2005001,C0693282	Lithuania		PRODUCT NAME: DULOXETINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/04/280/001, EU/1/04/280/002, EU/1/04/280/003, EU/1/04/280/004, EU/1/04/280/005, EU/1/04/280/006 20040811

Market Dynamics and Financial Trajectory for Cymbalta (Duloxetine)

Introduction to Cymbalta (Duloxetine)

Cymbalta, known generically as duloxetine, is a medication used to treat a variety of conditions including depression, anxiety disorders, fibromyalgia, and neuropathic pain. Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders in the pharmaceutical industry.

Market Growth Drivers

The duloxetine market is driven by several key factors:

Rising Prevalence of Mental Health Disorders

The increasing rates of anxiety and depression globally are significant drivers for the duloxetine market. As mental health awareness grows, so does the demand for effective treatments like duloxetine[1][3][4].

Growing Healthcare Expenditure

Rising healthcare expenditure and improvements in healthcare infrastructure, particularly in regions like North America and Asia-Pacific, contribute to the market's growth. This increased spending enables more people to access mental health treatments[1][3].

Expanding Therapeutic Applications

Duloxetine's approval for various conditions, including off-label uses such as diabetic neuropathy and fibromyalgia, expands its market potential. The drug's effectiveness in treating a range of diseases makes it a preferred choice among healthcare practitioners[3][4].

Generic Drug Penetration

The rise in generic drug penetration is another factor driving the market. As patents expire, generic versions of duloxetine become available, increasing accessibility and affordability for patients[4].

Market Size and Forecast

Current Market Size

The duloxetine market was valued at USD 4.3 billion in 2023 and is expected to grow significantly in the coming years[3].

Projected Growth

The market is projected to reach USD 7.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.8% from 2024 to 2031. For the active pharmaceutical ingredients (API) market, the size is expected to reach USD 20.88 billion by 2031, growing at a CAGR of 4.60% during the same period[3][4].

Geographical Market Analysis

Dominant Regions

North America currently dominates the duloxetine market due to high awareness about mental health disorders, the presence of major key players, high disposable income, and well-developed healthcare infrastructure[1].

Emerging Markets

The Asia-Pacific region is expected to show significant growth during the forecast period due to increasing research and development activities and rising awareness about mental health disorders in this region[1].

Financial Performance of Key Players

Eli Lilly and Company

Eli Lilly, the original manufacturer of Cymbalta, has seen fluctuations in revenue due to the entry of generic competition. Despite this, the company reported solid financial performance in 2021, with revenue increasing by 8% in the fourth quarter. However, the loss of exclusivity in certain markets led to lower realized prices for some products, including Cymbalta[2].

Impact of Generic Competition

The entry of generic versions of duloxetine has impacted Eli Lilly's revenue from Cymbalta. The company's financial reports indicate a decrease in net income and EPS due to the loss of exclusivity and the subsequent generic competition[2].

Challenges and Limitations

Side Effects and Safety Concerns

Side effects associated with duloxetine, such as nausea, dizziness, and sleep disturbances, can hinder market growth. These safety concerns may lead to reduced prescription rates and patient compliance[1][4].

Economic Factors

Changing economic conditions in different regions can also impact the market. Economic instability can affect healthcare spending and access to medications like duloxetine[1][4].

Research and Development Activities

Emerging Opportunities

The rise in research and development activities is providing beneficial opportunities for the duloxetine market. New markets and emerging therapeutic applications are expected to drive growth in the forecast period[1].

Market Segmentation

Application and Product Segmentation

The duloxetine market is segmented based on application (capsules, tablets, extended-release capsules) and product (depression, anxiety, fibromyalgia, neuropathic pain). This segmentation helps in understanding the specific demand and growth potential in different therapeutic areas[3].

Key Takeaways

• The duloxetine market is driven by rising mental health disorders, growing healthcare expenditure, and expanding therapeutic applications.
• The market is expected to grow significantly, reaching USD 7.1 billion by 2031.
• North America dominates the market, while Asia-Pacific is expected to show substantial growth.
• Generic competition and side effects are key challenges.
• Research and development activities are crucial for market expansion.

FAQs

What are the primary drivers of the duloxetine market?

The primary drivers include the rising prevalence of anxiety and depression, growing healthcare expenditure, and expanding therapeutic applications.

How is the duloxetine market expected to grow in the coming years?

The market is expected to reach USD 7.1 billion by 2031, growing at a CAGR of 5.8% from 2024 to 2031.

Which regions dominate the duloxetine market?

North America currently dominates the market, while the Asia-Pacific region is expected to show significant growth.

What are the challenges facing the duloxetine market?

Challenges include side effects associated with duloxetine and changing economic conditions in different regions.

How has generic competition affected Eli Lilly's revenue from Cymbalta?

Generic competition has led to lower realized prices and a decrease in net income and EPS for Eli Lilly due to the loss of exclusivity in certain markets.

What role do research and development activities play in the duloxetine market?

Research and development activities provide beneficial opportunities for the market by opening up new therapeutic applications and emerging markets.

Sources:

1. Data Bridge Market Research - Global Duloxetine Market - Industry Trends and Forecast to 2028
2. Eli Lilly and Company - Lilly Reports Solid Fourth-Quarter and Full-Year 2021 Financial
3. Market Research Intellect - Duloxetine Market Size, Share, Growth & Forecast [2031]
4. Verified Market Research - Duloxetine Active Pharmaceutical Ingredients (API) Market Size And Forecast