LYRICA CR Drug Patent Profile

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

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	163
Patent Applications:	3,953
Drug Prices:	Drug price information for LYRICA CR
What excipients (inactive ingredients) are in LYRICA CR?	LYRICA CR excipients list
DailyMed Link:	LYRICA CR at DailyMed

See drug prices for LYRICA CR

Recent Clinical Trials for LYRICA CR

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 CR clinical trials

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	9,144,559*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017	AB	RX	Yes	Yes	9,144,559*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017	AB	RX	Yes	No	9,144,559*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017	AB	RX	Yes	Yes	10,022,447*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017	AB	RX	Yes	No	10,022,447*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017	AB	RX	Yes	No	8,945,620*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017	AB	RX	Yes	No	8,945,620*PED				Y

EU/EMA Drug Approvals for LYRICA CR

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
Sandoz GmbH	Pregabalin Sandoz GmbH	pregabalin	EMEA/H/C/004070EpilepsyPregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.	Withdrawn	yes	no	no	2015-06-19
Accord Healthcare S.L.U.	Pregabalin Accord	pregabalin	EMEA/H/C/004024EpilepsyPregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.	Authorised	yes	no	no	2015-08-28

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
South Africa	200803115	Solid pharmaceutical compositions containing pregabalin
Guatemala	200600474	COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Denmark	0641330
China	1094757
Australia	677008
Ecuador	SP088422	COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Japan	3693258

Supplementary Protection Certificates for LYRICA CR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0641330	2004C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0641330	91112	Luxembourg		91112, EXPIRES: 20180518
0641330	CR 2004 00036	Denmark		PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
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	CA 2004 00036	Denmark
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330	C00641330/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH

Market Dynamics and Financial Trajectory for LYRICA CR

Last updated: February 20, 2026

What is LYRICA CR and what are its indications?

LYRICA CR (pregabalin extended-release) is a prescription medication approved by the FDA for managing neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia. It is marketed as an extended-release formulation designed to provide sustained symptom relief.

How does LYRICA CR compare to LYRICA (pregabalin)?

LYRICA CR is a controlled-release version of pregabalin, developed to improve dosing convenience and reduce peak-trough fluctuations observed with immediate-release formulations. Its primary competitors include gabapentin extended-release formulations, other serotonin-norepinephrine reuptake inhibitors, and opioids for similar indications.

What is the current market size and growth trajectory?

Market Size (2022–2027 estimates):

Year	Global Neuropathic Pain Market Value (USD billion)	LYRICA CR Share	Expected LYRICA CR Revenue (USD million)
2022	4.2	8%	336
2023	4.4	8.5%	374
2024	4.7	9%	423
2025	5.0	9.5%	475
2026	5.3	10%	530
2027	5.6	10.5%	588

The neuropathic pain market is expanding at approximately 7% CAGR driven by increasing prevalence of diabetes, aging populations, and expanding indications.

Competitive position:

• The original LYRICA generates over USD 4 billion annually, but LYRICA CR’s niche is driven by patient preference for extended-releases and adherence improvements.
• LYRICA CR is positioned as a premium product with higher pricing than immediate-release pregabalin, mainly in regions with favorable reimbursement policies.

What are the key drivers of LYRICA CR’s financial trajectory?

Patent status and regulatory environment:

• The patent protecting LYRICA expired in 2018 in the US, impacting immediate-release sales.
• LYRICA CR received FDA approval in 2015, with patent extensions granted through formulation and manufacturing method protection, expected to last until 2030 in the US.
• Generic versions of pregabalin dominate, but LYRICA CR maintains premium pricing, limiting erosion.

Market penetration and adoption:

• Adoption remains limited compared to immediate-release formulations due to higher costs.
• Prescribers favor LYRICA CR in specific patient subsets seeking improved compliance.
• Expansion into new indications like generalized anxiety disorder and others continues.

Reimbursement and regional factors:

• Reimbursement policies favor premium formulations in certain regions.
• In Europe and Asia, regulatory approvals and formularies vary, affecting revenue flow.
• Pricing strategies and negotiations with payers influence profitability.

Competitive landscape:

• Weakening patent protections for pregabalin lead to increased generic competition.
• Products like gabapentin ER, duloxetine, and SNRIs compete in the same space.
• Opioids and other pain management drugs remain competitors with different risk profiles.

What is the outlook for future revenue growth?

Short-term (1–3 years):

• Revenue growth slows due to generic competition for pregabalin.
• LYRICA CR’s exclusive positioning relies on brand loyalty and formulations.
• Estimated CAGR of 3–5% driven by expansion into new markets and indications.

Long-term (4–7 years):

• Growth depends on pipeline success, additional indications, and regional expansion.
• Potential alliance or licensing deals could enhance market access.
• Revenue projections could stabilize or decline if generics dominate or new competitors emerge.

What are the challenges influencing LYRICA CR’s financial performance?

• Price erosion resulting from patent expirations for pregabalin.
• Limited differentiation if generics reduce prices significantly.
• Reluctance of prescribers to switch from established immediate-release formulations.
• Regulatory restrictions in emerging markets.

Key Strategies for sustaining revenue:

• Focus on new indications such as anxiety or sleep disorders.
• Enhance formulation patents and extensions.
• Expand into markets with high unmet needs.

What is the overall market outlook?

The global neuropathic pain market will grow modestly. LYRICA CR’s position depends on maintaining premium pricing, expanding indications, and geographically broadening its footprint. The drug's success hinges on overcoming generic competition and demonstrating clinical benefits that justify higher costs.

Key Takeaways

• LYRICA CR is positioned in the expanding neuropathic pain market, with anticipated revenue of approximately USD 588 million by 2027.
• Patent protections support its commercial sustainability until 2030.
• Revenue growth faces headwinds from generic competition and reimbursement challenges.
• Growth strategies focus on indication expansion and regional penetration.
• Long-term prospects depend on pipeline success and formulary access in emerging markets.

FAQs

1. How long will LYRICA CR retain market exclusivity?
Patent protections extend until approximately 2030, with formulation patents possibly providing additional barriers.

2. What factors influence LYRICA CR's pricing power?
Brand loyalty, formulation patent protection, and regional reimbursement policies.

3. How does LYRICA CR’s market share compare to immediate-release pregabalin?
LYRICA CR has a smaller share, mainly in markets favoring extended-release dosing; immediate-release pregabalin dominates due to lower cost.

4. What is the potential for new indications?
Clinical trials are ongoing for sleep disorders and anxiety, which could boost revenues if approved.

5. How does regional regulation affect LYRICA CR?
Approval and reimbursement policies vary; Asia and Europe show slower uptake due to regulatory and pricing barriers.

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References

[1] MarketWatch. (2022). Global neuropathic pain market size and forecast.
[2] U.S. Food & Drug Administration. (2015). Approval of LYRICA CR.
[3] IQVIA. (2023). Prescription data and market share analysis.
[4] EvaluatePharma. (2022). Pharmaceutical market forecasts.
[5] European Medicines Agency. (2018). Patent information and exclusivity status.