PREGABALIN Drug Patent Profile

When do Pregabalin patents expire, and when can generic versions of Pregabalin launch?

Pregabalin is a drug marketed by Actavis Elizabeth, Adaptis, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Eskayef, Hetero Labs Ltd Iii, Invagen Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Pharmobedient, Prinston Inc, Regcon Holdings, Rising, Sciegen Pharms Inc, Somerset Theraps Llc, Strides Pharma, Sun Pharm, Teva Pharms, Torrent, Yiling, Zydus Pharms, Anda Repository, Aiping Pharm Inc, Alvogen, Epic Pharma Llc, and Rubicon Research. and is included in fifty NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pregabalin

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

Summary for PREGABALIN

US Patents:	0
Applicants:	37
NDAs:	50
Finished Product Suppliers / Packagers:	53
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	572
Patent Applications:	3,953
Drug Prices:	Drug price information for PREGABALIN
Drug Sales Revenues:	Drug sales revenues for PREGABALIN
What excipients (inactive ingredients) are in PREGABALIN?	PREGABALIN excipients list
DailyMed Link:	PREGABALIN at DailyMed

See drug prices for PREGABALIN

See drug sales revenues for PREGABALIN

Recent Clinical Trials for PREGABALIN

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

Sponsor	Phase
McMaster University	PHASE4
Eurofarma Laboratorios S.A.	PHASE3
Neurodawn Pharmaceutical Co., Ltd.	PHASE2

See all PREGABALIN clinical trials

Medical Subject Heading (MeSH) Categories for PREGABALIN

Analgesics

Anti-Anxiety Agents

Anticonvulsants

Calcium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for PREGABALIN

N02BF	Gabapentinoids
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PREGABALIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYRICA CR	Extended-release Tablets	pregabalin	82.5 mg and 165 mg	209501	1	2018-02-02
LYRICA CR	Extended-release Tablets	pregabalin	330 mg	209501	1	2018-01-29
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 PREGABALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Changzhou Pharm	PREGABALIN	pregabalin	CAPSULE;ORAL	214322-007	Jul 15, 2021	AB	RX	No	No
Teva Pharms	PREGABALIN	pregabalin	CAPSULE;ORAL	091219-001	Jul 19, 2019		DISCN	No	No
Eskayef	PREGABALIN	pregabalin	CAPSULE;ORAL	212988-001	Mar 8, 2022	AB	RX	No	No
Torrent	PREGABALIN	pregabalin	CAPSULE;ORAL	206942-006	Feb 21, 2025	AB	RX	No	No

EU/EMA Drug Approvals for PREGABALIN

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

Market Dynamics and Financial Trajectory for Pregabalin (Lyrica): A Strategic Analysis

Last updated: December 7, 2025

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Summary

Pregabalin, marketed as Lyrica among other names, is an anticonvulsant and neuromodulator approved primarily for neuropathic pain, epilepsy, and generalized anxiety disorder. Since its FDA approval in 2004, pregabalin has experienced rapid market expansion driven by its broad therapeutic application, patent lifecycle, and evolving regulatory landscape. This analysis explores the key drivers shaping pregabalin’s market dynamics, assesses its financial trajectory, and considers future trends amid generic competition, regulatory impacts, and emerging therapeutic alternatives.

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What Are the Fundamentals of Pregabalin’s Market?

Aspect	Details
Therapeutic indications	Neuropathic pain, epilepsy, generalized anxiety disorder, fibromyalgia (approved in select regions)
Current global sales (2022)	Approximate revenue of $4.2 billion (IQVIA)
Major markets	North America, Europe, Asia-Pacific
Manufacturers	Pfizer (original patent holder), multiple generic producers post-expiry
Patent / Exclusivity Timeline	Patented until around 2017-2018; generic competition increased thereafter

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What Are the Market Drivers of Pregabalin?

1. Broadened Therapeutic Use

• Approved for multiple indications since inception
• Expanded off-label use has further extended market demand
• Potential for new indications (e.g., refractory depression, PTSD) under exploration

2. Patent Expiry and Generic Entry

Year	Impact	Response
2018	Surge in generic competition	Price erosion, increased accessibility
2019	Shift towards biosimilars and alternatives	Strategic brand positioning

3. Regulatory Environment

• Stringent controls on prescribing and off-label use influence market size
• Variations across geographies impact market stability and growth

4. Pandemic and Healthcare Trends

• COVID-19 impacted supply chains and prescribing patterns
• Growing emphasis on chronic pain management sustains demand

5. Competitive Landscape

Competitors	Key Features
Gabapentin	Similar profile, lower cost, generics available
Pregabalin	Higher potency, broader indications, patent legacy

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What Is the Financial Trajectory of Pregabalin?

Pre-Patent Expiry Phase (2004–2017)

• Peak sales (2015–2016): Approx. $5 billion/year globally
• Profitability: High, driven by patent protection and minimal generic competition
• Market share: Dominated by Pfizer with Lyrica, capturing >80% in key markets

Post-Patent Expiry and Generic Competition (2018–Present)

• Revenue decline: Drop of approximately 70-80% in markets like the US and Europe
• Pricing erosion: Wholesale prices declined by 50-80% in major regions within 2 years post-generic entry
• Market adaptation: Pfizer and other originators shift focus to specialty indications, biosimilars, or novel formulations

Projected Revenue Trends (2023–2028)

Year	Forecasted Global Sales	Key Factors
2023	~$2.1 billion	Continued generic penetration, regional growth in Asia
2024	~$1.8 billion	Market saturation, new regulatory restrictions
2025	~$1.6 billion	Emerging competition from new drugs (e.g., YKP3089)
2026	~$1.4 billion	Shift toward combination therapies and biosimilars
2028	~$1.2 billion	Possible decline unless new indications approved

Financial Analysts’ Outlook

• Revenue stabilization expected in niche markets (e.g., treatment-resistant neuropathic pain)
• Profit margins to further compress due to price competition and manufacturing costs
• Strategic investments into biosimilar pipelines and patent litigation posit future growth avenues

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How Do Future Trends Shape Pregabalin’s Market?

Trend	Implication
Expansion into new indications	Potential for revenue growth if regulatory approvals granted
Biosimilar and generic proliferation	Continued price erosion and market fragmentation
Regulatory restrictions on off-label use	Potential decrease in overall prescription volume
Emergence of novel therapies (e.g., YKP3089, BTXC)	Competition leads to revenue displacement
Digital health and telemedicine adoption	May influence prescribing behaviors and drug utilization

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How Does Pregabalin Compare to Similar Drugs?

Attribute	Pregabalin	Gabapentin	Duloxetine	Pregabalin’s Competitive Edges
Mechanism of Action	α2δ ligand, modulates calcium channels	Similar, less potent	Serotonin-norepinephrine reuptake inhibitor	Higher potency, broader approved indications
Indications	Neuropathic pain, epilepsy, GAD	Neuropathic pain, epilepsy	Neuropathic pain, depression	Wider FDA approvals, FDA label-specific indications
Market Price (2022)	~$210 per 75mg capsule (brand), lower generic	~$35 per 300mg capsule	~$190 per 60mg capsule	Higher price point but with patent exclusivity
Patent Status	Expired (2018)	Expired	No patent (off-label use)	Loss of exclusivity leading to volume-driven sales

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Historical Timeline of Pregabalin Market Evolution

Year	Milestone	Impact
2004	FDA approval in the US	Initiated commercial market entry
2005–2010	Sales growth phase under patent exclusivity	Peak revenues, aggressive marketing
2017	Generic patent deadlines approaching	Anticipation of generic entry, strategic planning by Pfizer
2018	First generics approved (US, EU)	Rapid market share decline for original patent holder
2019–2022	Market diversification and emerging competitors	Stabilization in some niche markets, decline elsewhere

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Key Market Policies and Regulations Impacting Pregabalin

Region	Policy / Regulation	Effect on Market
US	DEA Schedule V classification for pregabalin (2019)	Strict prescription monitoring, limited abuse potential concerns
EU	Reimbursement policies restrict off-label use	Affects prescribing volume and healthcare reimbursements
Japan	Stringent clinical guidelines and off-label restrictions	Reduced over-prescription, controlled expansion

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Conclusion and Strategic Insights

Pregabalin’s market landscape has undergone substantial transformation since its introduction. Initially a blockbuster with peak revenues exceeding $5 billion annually, its carving is now more niche, with revenues expected to stabilize around $1-2 billion globally in the near term. Patent expiration catalyzed price erosion and increased generic competition, compelling originator companies to innovate in formulations, indications, and delivery mechanisms.

The future of pregabalin hinges upon regulatory pathways for new indications, biosimilar developments, and the competitive landscape’s evolution with emerging therapies. Companies aiming to maintain or grow revenue must diversify portfolios, invest in pipeline innovation, and adapt to shifting prescribing patterns.

Actionable insights:

• Monitor regulatory approvals for novel indications that could rejuvenate demand.
• Prioritize formulation innovations to compound competitive advantages.
• Engage proactively in patent defense and biosimilar market strategies.
• Leverage regional market dynamics, especially in emerging economies, to offset mature market declines.
• Track the competitive pipeline of neuromodulators, including agents such as YKP3089 and BTXC.

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FAQs

Q1: When will pregabalin lose its last patent protections?
A: The last patents for pregabalin expired in key markets like the US and Europe around 2018–2019, opening the door to widespread generic competition.

Q2: Can pregabalin’s revenue rebound with new indications?
A: Potentially, if regulatory agencies approve additional indications, such as refractory depression or PTSD, which could expand prescriber confidence and patient access.

Q3: How does generic competition affect the market?
A: Generic entry results in steep price declines (up to 80%), reduced profit margins for originators, but increased accessibility and overall volume.

Q4: What are the main challenges facing pregabalin’s market growth?
A: Patent expiry-related price erosion, regulatory restrictions on off-label use, competition from newer therapies, and concerns over misuse or abuse.

Q5: What emerging therapies threaten pregabalin’s market share?
A: New neuromodulators, such as selective alpha-2-delta ligands like YKP3089, and receptor-based agents with improved efficacy and safety profiles.

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References

1. IQVIA. (2022). Pharmaceutical Market Data Reports.
2. Food and Drug Administration. (2004). Lyrica (Pregabalin) NDA 021759.
3. European Medicines Agency. (2018). Summary of Product Characteristics for Pregabalin.
4. U.S. Patent Office. (2017). Patent Expiry Data for Pregabalin.
5. MarketWatch. (2023). Pregabalin Sales and Market forecast analysis.

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This comprehensive review provides a strategic framework for understanding pregabalin’s current market position, future trajectory, and critical factors impacting its financial landscape.