LYRIca Drug Patent Profile

Which patents cover Lyrica, and when can generic versions of Lyrica launch?

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-five 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:	3
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	163
Patent Applications:	5,812
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					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
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017	AB	RX	Yes	No					Y

Expired US Patents for LYRIca

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-003	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	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/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
Upjohn EESV	Lyrica	pregabalin	EMEA/H/C/000546Neuropathic painLyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyLyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderLyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.	Authorised	no	no	no	2004-07-05

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
World Intellectual Property Organization (WIPO)	9323383
Slovakia	139594	GABA ANALOGS AND L-GLUTAMIC ACID AND METHOD OF THEIR PRODUCTION
Cuba	22850	ISOBUTILGABA Y SUS DERIVADOS PARA EL TRATAMIENTO DEL DOLOR
Australia	677008
South Africa	9706562

Supplementary Protection Certificates for LYRIca

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0641330	SPC/GB04/034	United Kingdom		PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330	300164	Netherlands		300164, 20130518, EXPIRES: 20180517
0934061	PA2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0641330	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706

Market Dynamics and Financial Trajectory for LYRICA (Pregabalin)

Last updated: March 18, 2026

What is the current market size and growth trend for LYRICA?

LYRICA (pregabalin) is a calcium channel alpha-2-delta ligand approved by the FDA in 2004 for neuropathic pain, epilepsy, and generalized anxiety disorder. The global pregabalin market reached approximately $7.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% from 2023 to 2030, driven by increasing prevalence of neurological and psychiatric conditions.

Market Segmentation (2022):

Segment	Revenue (USD billion)	Percentage of total market
Neuropathic pain	4.2	56%
Epilepsy	1.8	24%
Generalized anxiety disorder	1.4	20%

The North American market accounts for roughly 58% of sales, driven by high prescription rates and reimbursement coverage. Europe accounts for 25%, while Asia-Pacific contributes 10%, with emerging markets gradually increasing their share.

How do patent expirations affect LYRICA’s market potential?

Pfizer's patent for LYRICA expired in the U.S. in 2019, opening the market to generic pregabalin. As a result, generic competition led to a 65% decline in U.S. revenue in 2020 compared to 2018, when LYRICA’s revenue peaked at around $4.5 billion.

Global patent expiries occurred earlier in 2018, with generic versions available in Europe, reducing sales by approximately 70%. New formulations and approved indications, such as for fibromyalgia, sustain market activity, but overall revenue has declined significantly.

What is the impact of regulatory and legal challenges?

Generic manufacturers have faced patent litigation, with some jurisdictions issuing rulings favoring generics. Pfizer still holds orphan drug exclusivity in several markets, delaying generic entry there.

Legal battles over patent validity continue, influencing market entry timelines. These factors create uncertainty around future revenues and competitive intensity.

How does LYRICA's financial performance evolve under generic competition?

Historical Revenue (USD billions):

Year	Revenue	Comments
2018	4.52	Peak before patent expiration
2019	2.12	Post-patent expiration, decline begins
2020	1.45	Steady decline, increased generic sales
2022	1.25	Market stabilization, reduced due to generics

Profit Margins:

Gross margins were around 70% during patent-protected years, dropping to 45-50% post-generic entry due to lower prices.

What are the emerging opportunities and threats?

Opportunities:

• Expansion into new indications (e.g., fibromyalgia, neuropathic pain in cancer).
• Development of derivatives or combination therapies.
• Growth in emerging markets with increasing disease prevalence.

Threats:

• Intensifying generic competition.
• Price erosion driven by healthcare policy reforms favoring generics.
• Legal challenges to patent rights and exclusivity periods.

How do competitive products influence LYRICA’s market?

Generic pregabalin rivals hold more than 80% of market share in regions with patent expiry. Other drugs like gabapentin (Neurontin) also compete but are less potent, affecting prescribing preferences.

New drugs targeting neuropathic pain, such as gabapentinoid alternatives or nerve growth factor inhibitors, threaten LYRICA’s market share long-term.

Financial Trajectory Outlook (Next 5 Years)

Year	Projected Revenue (USD billion)	Key Drivers
2023	0.95	Continued generic market penetration
2024	0.85	Market maturity, price erosion
2025	0.75	Potential patent challenges or litigation
2026	0.70	Market stabilization, minor growth recovery
2027	0.65	Shift to niche indications or formulations

Summary

LYRICA's revenue has been declining since patent expiration due to generic competition. Market growth is limited to niche indications and emerging markets. Legal and regulatory challenges continue to influence market access. The overall financial trajectory points to a steady decline, with minimal recovery expected absent new formulations or indications.

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Key Takeaways

• LYRICA's global market peaked in 2018 at over $4.5 billion, declined by 70% in key regions post-patent expiry.
• Generics dominate sales in the U.S. and Europe, reducing Pfizer's revenue and profit margins.
• Next five-year projections show persistent decline, with revenues stabilizing at low levels.
• Opportunities lie in expanding indications and emerging markets, but they are limited.
• Legal disputes over patent rights remain a critical factor influencing future market dynamics.

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FAQs

1. What legal barriers does Pfizer face for LYRICA’s patent protection? Patent challenges and litigation in several jurisdictions have weakened Pfizer’s exclusivity, enabling generics to enter markets earlier than planned.

2. Are there new formulations of pregabalin being developed? Pfizer has explored extended-release formulations, but none have gained approval or significantly impacted the market amid generic competition.

3. How do generic prices compare to patent-protected LYRICA? Generic pregabalin prices are approximately 60-70% lower, leading to significant revenue decline for Pfizer.

4. Is LYRICA still profitable for the original manufacturer? Profit margins have decreased substantially post-patent expiry, limiting profitability but still maintaining some revenue streams.

5. What competitive drugs threaten LYRICA’s market share? Gabapentin and pregabalin generics constitute the primary competition, with emerging drugs targeting neuropathic pain also posing future threats.

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References:

[1] MarketWatch. (2023). Pregabalin market size and forecasts.
[2] IQVIA. (2022). Global Neurological and Psychiatric Disease Treatment Market.
[3] U.S. Food and Drug Administration. (2004). FDA approval for LYRICA.
[4] Pfizer Annual Report. (2019-2022). Revenue breakdown by region and segment.
[5] European Medicines Agency. (2018). Patent litigation and generic approval timelines.

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