LYRICA Drug Patent Profile

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

Lyrica is a drug marketed by Upjohn and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in LYRICA is pregabalin. There are forty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lyrica

A generic version of LYRICA was approved as pregabalin by ALEMBIC on July 19^th, 2019.

Summary for LYRICA

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	161
Patent Applications:	4,110
Drug Prices:	Drug price information for LYRICA
Drug Sales Revenues:	Drug sales revenues for LYRICA
What excipients (inactive ingredients) are in LYRICA?	LYRICA excipients list
DailyMed Link:	LYRICA at DailyMed

See drug prices for LYRICA

See drug sales revenues for LYRICA

Recent Clinical Trials for LYRICA

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

Sponsor	Phase
University of Miami	Phase 4
Henry Ford Health System	Phase 4
An-Najah National University	Phase 2/Phase 3

See all LYRICA clinical trials

Paragraph IV (Patent) Challenges for LYRICA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYRICA	Oral Solution	pregabalin	20 mg/mL	022488	1	2010-05-19
LYRICA	Capsules	pregabalin	25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg	021446	8	2008-12-30

US Patents and Regulatory Information for LYRICA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004	AB	RX	Yes	No
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017	AB	RX	Yes	Yes					Y
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004	AB	RX	Yes	No

Expired US Patents for LYRICA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004

EU/EMA Drug Approvals for LYRICA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Zentiva k.s.	Pregabalin Zentiva k.s.	pregabalin	EMEA/H/C/004277 Neuropathic painPregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderPregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.	Withdrawn	yes	no	no	2017-02-27
Zentiva, k.s.	Pregabalin Zentiva	pregabalin	EMEA/H/C/003900 Neuropathic pain, , , Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults., , , Epilepsy, , , Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation., , , Generalised anxiety disorder, , , Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults., ,	Authorised	yes	no	no	2015-07-17
Mylan S.A.S.	Pregabalin Mylan Pharma	pregabalin	EMEA/H/C/003962 EpilepsyPregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.	Withdrawn	yes	no	no	2015-06-25

International Patents for LYRICA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1021134
Cuba	22850	ISOBUTILGABA Y SUS DERIVADOS PARA EL TRATAMIENTO DEL DOLOR
Canada	2134674	ANALOGUES DE GABA ET DE L'ACIDE L-GLUTAMIQUE POUR LE TRAITEMENT DES CONVULSIONS (GABA AND L-GLUTAMIC ACID ANALOGS FOR ANTISEIZURE TREATMENT)

Supplementary Protection Certificates for LYRICA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0641330	SPC016/2004	Ireland		SPC016/2004: 20050803, EXPIRES: 20180517
0641330	CR 2004 00036	Denmark		PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0641330	CA 2004 00036	Denmark

Market Dynamics and Financial Trajectory for the Drug: LYRICA

Introduction

LYRICA, known generically as pregabalin, is a versatile medication used to treat a variety of conditions including epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, and generalized anxiety disorder. Here, we delve into the market dynamics and financial trajectory of LYRICA, highlighting key drivers, market performance, and the impact of generic competition.

Market Drivers

Rise in Prevalence of Epilepsy and Other Conditions

The global pregabalin market is driven significantly by the increasing prevalence of epilepsy and other conditions for which LYRICA is prescribed. According to the World Health Organization (WHO), approximately 50 million people worldwide live with epilepsy, with a significant portion residing in low- and middle-income countries where access to treatment is limited[1].

Extensive Application of LYRICA

LYRICA's broad range of indications contributes to its market growth. It is widely used for managing neuropathic pain, fibromyalgia, and anxiety disorders, making it a valuable option for patients and healthcare providers alike[1].

Market Performance

Revenue Growth

In the fourth quarter of 2008, LYRICA revenues saw a significant year-over-year increase of 25%, driven by strong physician prescribing patterns and patient satisfaction. This growth was particularly notable in the U.S. and international markets, with revenues reaching $702 million for the quarter[2].

Forecast and Market Size

The global pregabalin market, which was valued at USD 824.75 million in 2023, is expected to grow to USD 1,088.56 million by 2031, with a Compound Annual Growth Rate (CAGR) of 3.53% during the forecast period from 2024 to 2031[1].

Geographic Dominance

North America

North America is anticipated to hold the largest market share of the global pregabalin market by 2030. This dominance is attributed to the well-established healthcare infrastructure, widespread use of new technology, and government efforts to maintain health data. The region also sees a high prevalence of chronic diseases such as neuropathy, diabetes, and HIV, which drive the demand for pregabalin[4].

Impact of Generic Competition

Patent Expiry and Generic Entry

LYRICA's patent was set to expire at the end of 2018, but Pfizer secured a pediatric exclusivity extension, delaying generic competition until June 2019. The FDA approved generic pregabalin in July 2019, marking a significant shift in the market[3].

Financial Impact of Generics

The introduction of generic pregabalin led to substantial cost savings. Total spend on LYRICA decreased by 54% in August 2019 compared to July, despite a comparable prescription count. Generic utilization of pregabalin reached 85% in August, resulting in a 30.2% reduction in cost per script[3].

Financial Trajectory

Pfizer's Revenue Impact

The loss of exclusivity for LYRICA in the U.S. in July 2019 significantly impacted Pfizer's revenues. In the fourth quarter of 2019, Pfizer's Upjohn segment, which includes LYRICA, saw an operational decline of 32% primarily due to this loss of exclusivity[5].

Historical Revenue Performance

In 2008, LYRICA revenues were $702 million for the fourth quarter, with a year-over-year increase of 25%. This growth was driven by strong prescribing patterns and increased use for fibromyalgia in the U.S.[2].

Future Financial Guidance

Pfizer's financial guidance for 2020 reflected the impact of generic competition on LYRICA. Despite this, Pfizer's Biopharma segment showed operational growth driven by other products like Ibrance, Eliquis, and Xeljanz, offsetting some of the decline from LYRICA[5].

Distribution and End-Users

Dosage Forms and Distribution Channels

The market for pregabalin is segmented by dosage forms (oral capsule, oral solution, oral tablet, extended release), with oral forms dominating due to rising demand. Distribution channels include hospital pharmacies, retail pharmacies, online pharmacies, and others, with hospital pharmacies being a significant segment[1].

End-Users

Hospitals, specialty clinics, and homecare settings are key end-users of pregabalin. The demand from these sectors is driven by the need for effective management of chronic pain and neurological conditions[1].

Regulatory Framework

FDA Approvals and Extensions

Pfizer's efforts to extend the patent life of LYRICA through pediatric exclusivity and the approval of an extended-release formulation (Lyrica CR) in October 2017 were strategic moves to maintain market share. However, the eventual approval of generic pregabalin in July 2019 marked a significant regulatory shift[3].

Key Takeaways

• The global pregabalin market is driven by the increasing prevalence of epilepsy and other conditions.
• LYRICA's broad range of indications contributes to its market growth.
• The market is expected to grow from USD 824.75 million in 2023 to USD 1,088.56 million by 2031.
• North America dominates the market due to its well-established healthcare infrastructure and high prevalence of chronic diseases.
• Generic competition has significantly reduced the cost of pregabalin, leading to substantial savings.
• Pfizer's revenues were impacted by the loss of exclusivity for LYRICA in the U.S.

FAQs

What is LYRICA used for?

LYRICA (pregabalin) is used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, and generalized anxiety disorder.

How has the introduction of generic pregabalin affected the market?

The introduction of generic pregabalin has led to a significant reduction in costs, with total spend on LYRICA decreasing by 54% despite a comparable prescription count.

What is the forecasted market size for pregabalin by 2031?

The global pregabalin market is expected to reach USD 1,088.56 million by 2031, growing at a CAGR of 3.53% from 2024 to 2031.

Which region dominates the global pregabalin market?

North America is expected to hold the largest market share of the global pregabalin market by 2030.

How did Pfizer's revenues change after the loss of exclusivity for LYRICA?

Pfizer's Upjohn segment saw an operational decline of 32% in the fourth quarter of 2019 due to the loss of exclusivity for LYRICA in the U.S.

What is the impact of generic drugs on healthcare costs?

Generic drugs, such as generic pregabalin, save the healthcare system significant amounts by reducing research costs and allowing for substantial discounts compared to brand-name drugs[3].

Sources

1. Data Bridge Market Research - Global Pregabalin Market – Industry Trends and Forecast to 2031
2. Pfizer - Pfizer Reports Fourth-Quarter and Full-Year 2008 Results and 2009 Financial Guidance
3. myMatrixx - The Financial Impact of Generic Lyrica is a Big Deal
4. Maximize Market Research - Pregabalin Market: Industry Analysis and Forecast (2024-2030)
5. Pfizer - Pfizer Reports Fourth-Quarter and Full-Year 2019 Results Provides 2020 Financial Guidance

Last updated: 2024-12-16