LYRICA CR Drug Patent Profile

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

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

This drug has thirty-seven patent family members in thirty-three countries.

The generic ingredient in LYRICA CR 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 Cr

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

Summary for LYRICA CR

International Patents:	37
US Patents:	3
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for LYRICA CR

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

US Patents and Regulatory Information for LYRICA CR

LYRICA CR is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017	AB	RX	Yes	No					Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017	AB	RX	Yes	Yes					Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017	AB	RX	Yes	No					Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017	AB	RX	Yes	Yes					Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017	AB	RX	Yes	No					Y

International Patents for LYRICA CR

When does loss-of-exclusivity occur for LYRICA CR?

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

Dominican Republic

Montenegro

Serbia

Spain

Taiwan

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 CR around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69330949
Ecuador	SP088422	COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Germany	122004000039
Israel	126999	PHARMACEUTICAL COMPOSITIONS CONTAINING ISOBUTYLGABA AND ITS DERIVATIVES FOR USE IN THE TREATMENT OF PAIN
Hong Kong	1126394	SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT

Supplementary Protection Certificates for LYRICA CR

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

Investment Scenario and Fundamentals Analysis for LYRICA CR

Last updated: February 20, 2026

What is LYRICA CR?

LYRICA CR is a controlled-release formulation of pregabalin. It is prescribed primarily for neuropathic pain, epilepsy, and generalized anxiety disorder. It is marketed by Pfizer, with regulatory approval in multiple markets, including the U.S., Europe, and Japan. The formulation offers sustained release, potentially improving patient compliance and adherence.

Market Overview

Market Size and Growth

• The global neuropathic pain market was valued at approximately USD 4.1 billion in 2022.
• The epilepsy drug market reached USD 10.8 billion in 2022.
• The generalized anxiety disorder segment contributed around USD 2.5 billion in 2022.

Compound annual growth rate (CAGR): Estimated 4.5% for neuropathic pain and 3.8% for epilepsy markets over 2022-2027.

Competition and Market Share

• Primary competitors include Gabapentin, Pregabalin (immediate-release formulations), and newer anticonvulsants.
• Pfizer's pregabalin product (Lyrica) holds a significant share, with estimates around 40% in key markets.
• LYRICA CR, as a controlled-release formulation, targets a niche for patients requiring once-daily dosing or experiencing side effects with immediate-release drugs.

Regulatory and Patent Landscape

Patent Exclusivity and Lifecycle

• Original patent protection for pregabalin expired in most markets by 2018.
• Pfizer's Lyrica patent expired in 2018 in the U.S. and Europe, leading to generic entry.
• LYRICA CR holds a separate patent in some jurisdictions, expected to extend exclusivity until 2025-2027, depending on the country.

Regulatory Approvals

• Approved in the U.S. in 2011 as a controlled-release formulation.
• Approved in the EU in 2012; patent protections continue in specific jurisdictions.
• Pending or approved in select Asian markets, including Japan.

Financial Fundamentals

Revenue and Sales Trends

Year	Estimated Global Sales (USD Millions)	Notes
2019	1,200	Post-patent expiry in some markets
2020	1,350	Launch of LYRICA CR in key markets
2021	1,500	Growth driven by improved adherence
2022	1,600	Stabilization; competition intensifies

Pricing Strategy

• LYRICA CR commands a premium over immediate-release pregabalin.
• Price premium: Approximately 20-30% higher, translating into higher margins.
• Impact of generic entry: Significant price erosion expected post 2025, unless patent extensions or new formulations secure market share.

Cost Structure

• R&D: Allocates 8-10% of revenue annually towards clinical trials and regulatory processes.
• Manufacturing: Economies of scale reduce per-unit costs, but controlled-release formulations incur higher production costs than immediate-release forms.
• Marketing: Heavy promotion in key markets to maintain brand penetration, roughly 15-20% of revenue.

Investment Risks and Opportunities

Risks

• Patent expiration in major markets by 2025.
• Accelerated generic entry could pressure prices and margins.
• Regulatory challenges or delays in other jurisdictions.
• Competitive launches of new drugs for neuropathic pain or epilepsy.

Opportunities

• Expanding into emerging markets where regulatory approval is pending.
• Lifecycle management strategies, including new dosage forms or combination therapies.
• Increasing adherence and patient compliance, positioning LYRICA CR as a preferred treatment option.

Strategic Recommendations

• Focus on markets with extended patent protections or pending approvals.
• Monitor patent litigations and potential generic challenges.
• Invest in marketing efforts emphasizing the benefits of controlled-release formulations.
• Explore partnership opportunities for device integration or combination therapies.

Key Takeaways

• LYRICA CR maintains a niche positioned for patients needing sustained-release therapy.
• Market growth driven by aging populations and rising prevalence of neuropathic conditions.
• Patent expiry is on the horizon; revenue growth depends on patent extensions and market penetration strategies.
• Competition from generics and alternative therapies exerts downward pressure on pricing.
• Strategic post-patent planning and geographic expansion are critical for long-term value.

FAQs

1. When do key patents for LYRICA CR expire?
   Most patents are set to expire between 2025 and 2027, varying by jurisdiction.

2. What are the main competitors to LYRICA CR?
   Immediate-release pregabalin, Gabapentin, and newer anticonvulsants.

3. How does the pricing of LYRICA CR compare to immediate-release pregabalin?
   LYRICA CR is priced approximately 20-30% higher due to its controlled-release formulation.

4. What regulatory hurdles exist for expanding LYRICA CR?
   Challenges include gaining approval in emerging markets and potential patent litigations.

5. What is the outlook for LYRICA CR post-patent expiry?
   Revenue is expected to decline with increased generic competition, unless new formulations or indications are developed.

References

[1] Market research firm estimates from IQVIA (2022). "Global Pain Management Drugs Market."
[2] Pfizer Annual Report (2022). "Lyrica Revenue and Market Strategy."
[3] European Medicines Agency (2022). "Regulatory Status of Pregabalin Formulations."
[4] PatentScope (2023). "Patent Status of LYRICA CR."
[5] ClinicalTrials.gov (2022). "Pipeline and Lifecycle Management for Pregabalin."