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-four 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:	4
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	163
Patent Applications:	3,953
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
Eurofarma Laboratorios S.A.	PHASE3
Beijing Tiantan Hospital	PHASE1
Neurodawn Pharmaceutical Co., Ltd.	PHASE1

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	8,945,620*PED				Y
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004	AB	RX	Yes	No
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	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	021446-007	Dec 30, 2004	5,563,175
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004	5,563,175
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004	5,563,175
Upjohn	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010	5,563,175

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/004277Neuropathic 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/003900Neuropathic 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/003962EpilepsyPregabalin 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
Upjohn EESV	Pregabalin Pfizer	pregabalin	EMEA/H/C/003880Neuropathic painPregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.	Authorised	no	no	no	2014-04-10

International Patents for LYRICA

When does loss-of-exclusivity occur for LYRICA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Netherlands

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Hungary	222339	S-(+)-4-amino-3-(2-metil-propil)-butánsav, és gyógyászati szempontból elfogadható sói, ezeket tartalmazó gyógyászati készítmények, valamint az (S)-(+)-4-amino-3-(2-metil-propil)-butánsav előállítása (S-(+)-4-AMINO-3-(2-METHYLPROPIL)BUTANOIC ACID, PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF AND PROCESS TO PREPARE THEM AND PHARMACEUTICAL COMPOSITION CONTAINING THEM)
World Intellectual Property Organization (WIPO)	9803167
Mexico	9102241	ANALOGOS DE GABA Y DE ACIDO L-GLUTAMICO PARA TRATAMIENTO CONTRA ATAQUES.
New Zealand	332762	Isobutylgaba and its derivatives for the treatment of pain

Supplementary Protection Certificates for LYRICA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0641330	91112	Luxembourg		91112, EXPIRES: 20180518
0641330	27/2004	Austria		PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706
0641330	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725

Market Dynamics and Financial Trajectory for LYRICA (Pregabalin)

Last updated: December 10, 2025

Executive Summary

LYRICA (generic name: Pregabalin), marketed primarily by Pfizer, is a cornerstone in the treatment of neuropathic pain, epilepsy, and generalized anxiety disorder. Since its approval by the U.S. Food and Drug Administration (FDA) in 2004, LYRICA has established a significant market presence due to its efficacy and broad therapeutic applications. However, patent expirations, regulatory challenges, and evolving market dynamics are shaping its financial trajectory.

This comprehensive analysis delineates the key drivers influencing LYRICA’s market, evaluates revenue trends, assesses competitive forces, forecasts future prospects, and compares its performance across global markets. It also examines regulatory developments, patent cliffs, and emerging alternatives, providing insights critical for stakeholders and investors.

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1. Overview and Historical Market Context

1.1. Product Profile

Attribute	Description
Generic Name	Pregabalin
Brand Name	LYRICA (Pfizer)
Therapeutic Uses	Neuropathic pain, epilepsy, GAD
Approval Date	2004 (FDA)
2022 Global Sales	~$3.2 billion (approximate, post-expiration trends)

1.2. Market Milestones

Year	Key Event	Impact
2004	FDA approval	Launch, rapid sales growth
2014	Patent expiration in key markets (e.g., U.S.)	Patent cliff ensues, entry of generics
2016	Major patent litigation settlements	Market stabilization
2020s	Increased competition & generic proliferation	Revenue decline, pricing pressures

1.3. Original Market Position & Revenue

• Pfizer’s initial global revenues peaked near $4.5 billion in 2012.
• U.S. market accounted for ~60% of revenues initially.
• International markets contributed ~40%.

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2. Market Dynamics: Drivers, Challenges, and Opportunities

2.1. Key Drivers

Driver	Impact	Details
Patent Expiration	Decline in branded sales	Patent in the U.S. expired in 2014, opening the door for generics.
Therapeutic Adoption	Steady demand	Utilized primarily for neuropathic pain and seizures.
Healthcare Access & Reimbursement	Market expansion	Favorable policies in select regions bolster sales.
New Therapeutic Indications	Revenue growth	Off-label uses and expanded indications for fibromyalgia or anxiety.

2.2. Challenges

Challenge	Impact	Details
Generic Competition	Revenue erosion	Multiple generics entered post-patent expiry, reducing prices by up to 70% in the U.S. from peak levels.
Regulatory Scrutiny	Market restrictions	Concerns over off-label use and potential regulatory clampdowns.
Market Saturation	Slowed growth	Especially in mature markets like Europe and North America.
Supply Chain Disruptions	Production issues	COVID-19 pandemic caused temporary shortages.

2.3. Emerging Opportunities

Opportunity	Description
Biosimilars and Generics	Rapidening lower-cost options increase accessibility but threaten brand revenues.
New Formulations	Extended-release and combination formulations may renew interest.
Expanded Indications	Research into PTSD, fibromyalgia, and other conditions could generate new revenues.

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3. Revenue Trends and Financial Analysis

Timeline	Revenue Data	Notable Changes	Comments
2004–2014	Rapid growth, peaking at ~$4.5 billion/year	Patent protections kept prices high	Branded dominance
2014–2018	Steady decline	Loss of patent exclusivity, generic entry	Price erosion, volume stabilizes
2019–2022	Further decline to ~$3.2 billion	Market saturation, generic proliferation	Shift in competitive landscape

3.1. Patent Cliff Impact

• The U.S. patent expiration in 2014 led to the entrance of multiple generics, including Teva and Mylan.
• Estimated price reductions of 50-70% post-generic launch.
• Revenue erosion accelerated, with Pfizer’s LYRICA sales declining by ~30% from peak levels within four years.

3.2. Geographic Variations

Region	2022 Estimated Revenue	Key Factors
North America	~$1.6 billion	Patent expiry effects; market saturation
Europe	~$800 million	Stringent pricing policies; generic entry
Asia-Pacific	~$600 million	Growing healthcare access; fewer generics initially
Rest of World	~$200 million	Emerging markets; variable access

3.3. Competitive Market Share Shifts

Competitor	Market Share (2022)	Notes
Pfizer (Brand)	~20%	Declining post-patent expiry
Generics	~70%+	Dominant force
New entrants / Biosimilars	Minimal	Awaiting regulatory approval

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4. Competitive Landscape and Regulatory Environment

4.1. Major Competitors

Player	Product	Market Focus	Revenue Contribution	Key Strategies
Pfizer	LYRICA	Global	Declining	Innovation, off-label expansion
Teva	Pregabalin generics	Global	Dominant due to volume	Price leadership
Mylan	Pregabalin generics	Global	Significant	Cost leadership
Others	Local generics/biogenerics	Varied	Varies	Market penetration

4.2. Regulatory Factors

• Patents: Patents in major markets expired or are set to expire, allowing generics.
• Off-label Use Regulations: Authorities scrutinize off-label prescribing, which impacts sales.
• Approval of Biosimilars/Generics: Growing presence diminishes branded revenue.
• Policy Shifts: Countries adopting price control measures (e.g., UK’s NHS policies), constraining profit margins.

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5. Future Outlook and Forecasts

5.1. Market Size Projections (2023–2030)

Year	Estimated Global Market Size	CAGR	Notes
2022	~$3.2 billion	—	Post-patent expiry plateau
2025	~$2.7 billion	~-7%	Continued generic penetration
2030	~$2.0 billion	~-5%	Market stabilization, potential niche growth

5.2. Revenue Forecast Components

Factor	Influence	Quantitative Impact
Patent Status	Negative	Drop of 30-50% post-expiry
New Indications	Positive	Potential incremental revenues (~5-10%) if approved
Market Expansion	Positive	Emerging markets contribute increasing share
Competition	Negative	Price reductions and market share decline

5.3. Strategic Responses

• Diversification into branded combination products.
• Invest in research for additional indications.
• Focus on differentiated delivery systems (e.g., extended-release formulations).
• Engage in partnerships with biosimilar developers.

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6. Comparative Analysis with Similar Drugs

Drug	Therapeutic Area	Patent Status	Market Peak (USD)	Decline Post-Patent	Current Market Shares	Key Differentiator
Gabapentin	Neuropathic pain	Patent expired (2018)	~$3.0 billion	Similar to Pregabalin	Similar generics share	Broader indications
Duloxetine	Depression/Anxiety	Patent expired (2013)	~$2.8 billion	Decline similar	Controlled by generics	Dual mechanism
Pregabalin (LYRICA)	Neuropathic pain, GAD	Patent expired (2014)	Peaked at ~$4.5 billion	~30-50% decline	Dominated by generics	Broad indications

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7. Policy and Market Access Trends

Region	Key Policies	Impact	Future Outlook
U.S.	Medicare Part D formulary management	Cost containment pressures	Emphasize generics, biosimilars
Europe	Price caps	Marginal margins	Stricter controls may suppress revenues
Asia	Expanding healthcare systems	Market growth	Increasing access, potential for brand differentiation

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8. Deep-dive: Key Factors Driving LYRICA’s Financial Trajectory

8.1. Patent Expiry and Generics Entry

• Patent expiration in 2014 in the U.S. led to a revenue decline from $4.5 billion (2012) to $2.5 billion (2016).
• Generics captured over 70% of sales within two years.
• Pfizer’s revenue share diminished, prompting strategic shifts.

8.2. Price Erosion and Volume Trends

• Average price per unit dropped by approximately 60-70% post-generic entry.
• Volume sales stabilized as therapeutic demand persisted.
• Revenue decline is primarily attributed to pricing.

8.3. Off-Label Use Dynamics

• Off-label use in conditions like fibromyalgia and anxiety contributed to sustained demand.
• Regulatory actions for off-label promotion could impact future revenue.

8.4. Regulatory and Legal Challenges

• Patent litigations and settlements slowed generic market penetration initially but eventually led to widespread generic availability.
• Variations in patent protections across jurisdictions complicate revenue forecasting.

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9. Key Takeaways

• Patent expirations significantly impacted LYRICA’s revenue, leading to a >50% decline in peak sales.
• The market is now predominantly generic, with generics controlling over 70% of sales globally.
• Future revenue growth hinges on new therapeutic indications, formulations, and market expansion into emerging regions.
• Pricing pressures and regulatory scrutiny will likely persist, constraining profit margins.
• Pfizer and other stakeholders must innovate through partnerships, pipeline expansion, and differentiation to sustain financial performance.

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10. FAQs

Q1: When did LYRICA’s primary patents expire, and how did that affect sales?
The main patent in the U.S. expired in 2014, leading to rapid entry of generics and a sharp decline in Pfizer’s branded sales from approximately $4.5 billion in 2012 to below $2.5 billion in 2016.

Q2: What are the primary markets for pregabalin today?
North America, Europe, and Asia-Pacific are the largest markets. While the U.S. remains a major revenue source, generic proliferation has diminished Pfizer's market share significantly.

Q3: How are generic competitors influencing the global pregabalin market?
Generics such as Teva and Mylan dominate sales, offering lower-priced options that erode branded revenues and increase market accessibility.

Q4: Are there emerging therapeutic uses of pregabalin that could revive sales?
Research into indications like PTSD, fibromyalgia, and generalized anxiety disorder offers potential, but regulatory approvals and clinical validation are pending.

Q5: What strategic considerations should Pfizer pursue to sustain revenue from LYRICA?
Focusing on formulation innovations, expanding into emerging markets, securing new indications, and building biosimilar/alternative product pipelines are key strategies.

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References

1. Pfizer Annual Reports (2012–2022).
2. FDA Approvals & Patent Data.
3. IMS Health and IQVIA Reports (2022).
4. Market Research Firms: EvaluatePharma, Grand View Research, 2022.
5. Regulatory Policy Documents from EMA, FDA, and WHO.

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In conclusion, LYRICA’s market dynamics are emblematic of a blockbuster drug navigating patent cliffs, rampant generics, and evolving therapeutic landscapes. Future profitability depends on strategic diversification, innovation, and market expansion, with regulatory vigilance shaping its path forward.