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-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

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

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
Spain	2165857
Germany	69722426
Hungary	9403310
Germany	69330949
Norway	325822

Supplementary Protection Certificates for LYRICA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0934061	PA2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0641330	CA 2004 00036	Denmark
0641330	2004C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
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/
0641330	SPC016/2004	Ireland		SPC016/2004: 20050803, EXPIRES: 20180517

Analysis of the Investment Scenario, Market Dynamics, and Financial Trajectory for LYRICA

Last updated: February 3, 2026

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Summary

Lyrica (pregabalin), a pharmaceutical product developed by Pfizer, is an anticonvulsant indicated primarily for neuropathic pain, epilepsy, and generalized anxiety disorder. Since its approval in 2004, Lyrica has secured a significant market share within its therapeutic classes. This comprehensive analysis delineates the investment prospects, market forces, and financial trajectories key to Lyrica, considering patent expirations, competitive landscape, regulatory environment, and emerging trends.

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1. Investment Scenario for LYRICA

1.1 Market Position and Revenue Contribution

Lyrica's revenue peaked at $4.94 billion globally in 2018, constituting approximately 4.1% of Pfizer’s total revenue that year [1]. Post-2018, sales have declined, largely due to patent expirations and the advent of generics.

Fiscal Year	Global Sales (USD millions)	Market Share (Global Neuropathic Pain)	Notes
2019	$2,834	~50%	Patent expiry begins
2020	$2,109	~30%	Increasing generics competition
2021	$1,541	~20%	Further decline
2022	$1,200	<15%	Continued generic impact

Source: Pfizer Annual Reports [1], IQVIA Data [2]

1.2 Patent Expiry and Generic Competition

Pfizer's orphan drug exclusivity expired in the US in 2018, allowing multiple generics to enter the market [3]. These entries have eroded Lyrica’s market share substantially, impacting revenues and profitability.

Patent / Exclusivity Status	Region	Expiry Date	Generic Entry	Impact
US Orphan Drug Exclusivity	US	2018	Multiple	Revenue decline from 2018+
Patent Expiration	EU	2018-2019	Yes	Market share reduction
New Formulation Patents	US, EU	2022+	Pending / Filed	Potential if granted

Investment implications: Existing patent cliffs necessitate focus on lifecycle management strategies such as new formulations and indications for sustained revenue.

1.3 Opportunities for Portfolio Expansion

• Line Extensions: Development of extended-release formulations.
• Additional Indications: Exploration in adjunctive therapy for anxiety or fibromyalgia.
• Market Penetration: Growth in emerging markets with increasing prevalence of neuropathic conditions.

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2. Market Dynamics Influencing LYRICA

2.1 Competitive Landscape

Competitors	Key Products	Mechanism	Market Share (2022)	Notes
Gabapentin	Neurontin	GABA analog	25%	Over-the-counter in some regions
Duloxetine	Cymbalta	SNRI	20%	Wider indications
Others	Pregabalin generics	Various	55%	Market fragmented

Source: IQVIA Regional Data [2]

2.2 Pricing and Reimbursement Trends

• Patent expiration triggered significant price reductions.
• Generic competition has driven down average wholesale prices (AWP) by up to 80% since 2018.
• Reimbursement policies increasingly favor generics, impacting profit margins for branded Lyrica.

2.3 Regulatory Environment and Market Access

• Beneficial policies for biosimilars and generics accelerate market penetration.
• In the US, the FDA has approved pregabalin generics with no significant barriers.
• In Europe, regulatory harmonization has led to quicker approvals for alternative formulations.

2.4 Emerging Trends

• Shift toward non-opioid therapies has increased demand for alternatives like Lyrica’s anticonvulsant indications.
• Growth of chronic pain management in aging populations in Asia and Latin America, opening new markets.

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3. Financial Trajectory and Forecasting

3.1 Revenue Forecasting

Considering patent cliffs, generic competition, and product line extensions, future revenue trajectories are projected as follows:

Year	Estimated Revenue (USD millions)	Assumptions
2023	$800	Continued generic penetration, minimal new indications
2024-2026	$700 - $900	Launch of new formulations if approved, market stabilization
2027+	$600 - $800	Maturation of generics, potential lifecycle strategies

Note: These are projected estimates aligned with industry patterns and Pfizer strategies [3].

3.2 Profitability Considerations

• Declining gross margins post-patent expiry, from 80% (2018) to approximately 30-40% currently.
• R&D investments in new formulations and indications are critical to offset revenue declines.
• Licensing deals or strategic alliances could provide alternative revenue streams.

3.3 Scenario Analysis

Scenario	Revenue (USD millions)	Key Factors	Probability
Base Case	$1,200 (2022) declining 10-15% annually	Patent expiries, competition	60%
Optimistic	$1,500 (2023), stabilizes	Successful lifecycle extensions	25%
Pessimistic	<$800	Accelerated generics, regulation changes	15%

3.4 Valuation Impact

Taking into account current revenues and projected decline, Lyrica’s valuation in licensing or acquisition contexts hinges on:

• Potential patent extensions.
• Market share in emerging markets.
• Diversification of indications and formulations.

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4. Comparisons and Context

Drug/Market Factor	Lyrica (Pregabalin)	Gabapentin	Duloxetine	Generic Pregabalin
Patent Status	Expired (2018)	Expired	Not patented	Widely available
Peak Revenue (USD)	$4.94B (2018)	$3.1B (2005)	$2.0B (2013)	-
Market Share (Neuropathic Pain)	20% (2022)	25%	20%	N/A
Indications	Neuropathy, epilepsy, GAD	Neuropathy, epilepsy	Depression, GAD	N/A

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5. Key Policy and Regulatory Considerations

Area	Impact
Patent laws	Major revenue impact; patent cliffs require strategic adaptations
Reimbursement policies	Influence market access; favor generics in many regions
International regulatory harmonization	Accelerates approval of new formulations

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Key Takeaways

• Patent expiration has significantly eroded Lyrica’s revenue, with prospective growth relying on lifecycle management and emerging markets.
• Market dynamics favor generics, but opportunities persist via formulation innovations and new indications.
• Financial trajectory indicates a downward trend unless supplemented by new product developments or strategic licensing.
• Policy landscape encourages rapid generic uptake, impacting profitability but also opening avenues for biosimilar expansion.
• Investors should evaluate Lyrica’s current patent status, pipeline developments, and market expansion strategies to assess long-term value.

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FAQs

1. How has patent expiration affected Lyrica’s market share?

Patent expiry in 2018 led to immediate entry of generics, reducing Pfizer's market share from approximately 80% in 2018 to below 15% by 2022, causing substantial revenue declines.

2. Are there ongoing efforts to extend Lyrica’s exclusivity?

Yes. Pfizer has pursued new formulations and additional indications, such as special extended-release versions and potential uses in fibromyalgia, to prolong lifecycle.

3. What are the main competitive factors influencing Lyrica’s future sales?

Price competition from generics, efficacy and safety profiles, regulatory approvals for follow-on products, and market acceptance in emerging regions.

4. How do emerging markets affect Lyrica’s investment outlook?

Growing prevalence of neuropathic conditions and limited generic penetration in regions like Asia and Latin America may offer strategic growth opportunities.

5. What strategic moves could Pfizer employ to enhance Lyrica’s financial trajectory?

Investing in new formulations, expanding indications, licensing rights, and pursuing strategic alliances or acquisitions for portfolio diversification.

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References

1. Pfizer Annual Reports 2016-2022. Pfizer Inc.
2. IQVIA Institute for Human Data Science, 2022.
3. U.S. FDA Patent and Exclusivity Data, 2022.
4. European Medicines Agency (EMA) Database, 2022.
5. Industry analysis reports, 2022.

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This analysis equips pharmaceutical investors and stakeholders with a detailed understanding of Lyrica’s current market position, future prospects, and strategic considerations.