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:	5,812
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
Neurodawn Pharmaceutical Co., Ltd.	PHASE1
Beijing Tiantan Hospital	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					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
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	209501-002	Oct 11, 2017	AB	RX	Yes	No					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
Argentina	058175	COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Australia	2006310217
Brazil	PI0618211	composição farmacêutica contendo pregabalina e uso do referido composto
Canada	2628200	COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSINGCONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
China	101330907	Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent
Costa Rica	9950	COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Cyprus	1115009

Supplementary Protection Certificates for LYRICA CR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0641330	91112	Luxembourg		91112, EXPIRES: 20180518
0641330	300164	Netherlands		300164, 20130518, EXPIRES: 20180517
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	CA 2004 00036	Denmark
0641330	SPC016/2004	Ireland		SPC016/2004: 20050803, EXPIRES: 20180517
0641330	C00641330/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0641330	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706

Last updated: June 23, 2026

LYRICA CR market dynamics and financial trajectory (US)

Executive summary: Pregabalin extended-release tablets (LYRICA CR) has matured into a lower-growth, loss-of-exclusivity-exposed branded franchise in the US. Market dynamics are dominated by (1) generic penetration of pregabalin across multiple immediate-release strengths and dosing regimens, (2) payor and pharmacy benefit manager (PBM) formulary pressure on branded pregabalin products, and (3) switching behavior between branded and generic pregabalin based on dose equivalence and side-effect/tolerability perceptions. Financial trajectory is shaped by brand share erosion, periodic wholesaler destocking cycles, contracting intensity in commercial channels, and ongoing generic supply expansion.

Core takeaways for business planning: Expect continued margin compression from competitive pricing, limited incremental volume growth, and a steady-to-declining revenue path unless new lifecycle events (new patents or reformulation) materially change competitive access. Litigation-driven “brand hold” is unlikely to reverse generic substitution dynamics at scale in late-stage markets for a mature CNS product.

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What is LYRICA CR (pregabalin extended-release) and where is it used?

Quick answer: LYRICA CR is pregabalin in an extended-release tablet format used for neuropathic pain and fibromyalgia indications in the US, with dosing designed to provide prolonged exposure relative to immediate-release pregabalin.

Indications and practical payer coverage

• Neuropathic pain
  • Includes painful diabetic peripheral neuropathy (PDPN) and postherpetic neuralgia (PHN).
• Fibromyalgia
• Dosing pattern
  • Extended-release schedule changes day-to-day dosing behavior versus immediate-release pregabalin, which can affect adherence and perceived tolerability.

Why formulation matters commercially

Extended-release products can sustain some differentiated uptake early, but in late stages:

• Generic immediate-release typically captures the bulk of neurologic pain spend once pricing compresses.
• Therapeutic substitution is common when formularies tier pregabalin classes broadly and apply copay differentials.

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How big is the LYRICA CR market and what drives volume?

Quick answer: The relevant market is the broader pregabalin neuropathic pain and fibromyalgia spend, with LYRICA CR taking a minority share after generic penetration.

Market demand drivers

• Neuropathic pain incidence and chronicity
  • Long treatment durations support baseline demand even as pricing falls.
• Switching and dose equivalence
  • Payors often treat pregabalin as a class or cluster drug with narrow clinical distinctions.
• Formulary design
  • PBMs use step edits and preferred generic tiers to reduce brand share.

Key volume sensitivities

• Copay and deductible structures
  • Brand-labeled copays drive adherence and persistence.
• Prior authorization (PA) and step therapy
  • These mechanisms tend to reduce brand share in favor of cheaper generics.
• Institutional channel dynamics
  • Health systems often standardize on generics for CNS pain.

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What market dynamics are most impacting LYRICA CR’s sales growth or decline?

Quick answer: The dominant forces are generic substitution and net price erosion.

1) Generic pregabalin pricing and shelf competition

• Immediate-release generic supply generally prices below branded pregabalin.
• Extended-release differentiation loses impact once PBMs prefer lowest-cost options.
• Pharmacy claims behavior increasingly reflects tier placement rather than formulation preference.

2) PBM contracting and clawback mechanics

• Branded manufacturers typically face:
  • Higher rebates for preferred access.
  • Increased pressure to match competitor net pricing.
• Net sales growth can diverge from gross sales due to rebate intensity.

3) Wholesale and channel inventory cycles

• CNS brands often show:
  • Periodic wholesaler destocking.
  • Follow-on restocking if demand stabilizes.
• These inventory shifts can create quarter-to-quarter noise, even when underlying patient demand is stable.

4) Persistence and tolerability narratives

• Prescriber confidence in extended-release pregabalin can persist in segments with:
  • adherence issues on immediate-release,
  • tolerability sensitivity,
  • patient preference after stabilization.
• These segments shrink as payer access tightens.

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What is the financial trajectory of LYRICA CR revenue and profitability?

Quick answer: The long-run pattern for mature pregabalin brands is revenue contraction with compressed margins as generic penetration intensifies and net prices fall.

Revenue drivers

• Units
  • Declines when brand share erodes and patients shift to generic pregabalin.
• Net price
  • Net price is pressured by contracting, rebates, and competitor undercutting.
• Mix
  • Any mix shift toward higher-cost strengths or institutional channels can temporarily stabilize net sales, but this rarely reverses the broader erosion trend.

Profitability drivers

• Gross-to-net compression
  • Rebates, discounts, and fees rise as the brand fights for formulary placement.
• Lifecycle spend
  • Increased investment in marketing and access programs usually cannot offset persistent price erosion.

Business interpretation

A typical late-stage branded CNS extended-release product shows:

• stable-to-declining volume,
• declining net price,
• net sales contraction,
• margin compression after peak access loss.

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When does LYRICA CR lose exclusivity and how does that affect generic entry risk?

Quick answer: Generic entry risk is already realized for pregabalin products, with ongoing competition from multiple generic manufacturers and continuing price pressure.

Why “loss of exclusivity” is not the whole story

Even after exclusivity ends, branded performance depends on:

• how quickly formularies move to preferred generic status,
• whether clinical habits maintain some brand loyalty,
• whether payer policies incentivize brand continuation through narrow PA or step criteria.

Implication for planning

• For new entrants: competition is structural and ongoing.
• For the brand: revenue stabilization requires differentiated access levers, not only patent status.

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What is the Orange Book status of LYRICA CR and what does it imply for market competition?

Quick answer: LYRICA CR’s Orange Book listings historically reflect an evolved patent estate with a number of patents that are no longer preventing generic competition at scale; the market is therefore shaped by generic product availability and contracting rather than ongoing exclusivity.

How to interpret Orange Book listings in commercial terms

• Approved ANDA/AB-rated competitors typically translate to:
  • shelf presence,
  • PBM formulary substitution,
  • rapid volume shifts once net pricing makes brand access unattractive.
• Method-of-use and formulation patents can delay a subset of launches, but class switching at PBM level often still drives revenue erosion.

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Which companies compete with LYRICA CR and what is the competitive landscape?

Quick answer: The competitive set is dominated by generic pregabalin manufacturers offering immediate-release capsules/tablets and, where available, extended-release offerings.

Competitive forces to track

• Generic count per strength
  • More ANDA products reduce the likelihood of stable brand net pricing.
• Launch timing and supply reliability
  • Rapid supply scaling accelerates payer substitution.
• PBM switching rules
  • Once preferred status changes, pharmacy fill patterns pivot quickly.

Practical market structure

• Retail and mail
  • Generally show faster generic share gains.
• Hospital and specialty
  • Exhibit slower transitions if formularies are slower to update, but end-to-end movement toward generics still occurs over time.

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How does LYRICA CR compare with generic pregabalin and with Lyrica (immediate-release)?

Quick answer: The clinical rationale for extended-release is dosing convenience and exposure profile. Commercially, those advantages usually diminish once generic immediate-release is priced far lower and formularies neutralize brand differentiation.

Commercial comparison

• LYRICA CR vs generic immediate-release
  • Generic wins on net price and often on formulary placement.
• LYRICA CR vs LYRICA (brand immediate-release)
  • If generic immediate-release is preferred, both lose to generics; product choice becomes a brand vs class question rather than formulation.

Patient and prescriber behavior

• Extended-release may retain small share in patients already stabilized.
• New starts are more likely to move toward generics if access restrictions exist for the brand.

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What patent litigation or settlements affect LYRICA CR’s competitive timing?

Quick answer: Pregabalin’s litigation history in the broader landscape has already played out enough to enable widespread generic availability; current dynamics are mainly contracting-driven rather than litigation-limited.

How litigation translates into market outcomes

• A stay from litigation can delay some entries, but:
  • PBMs can still prefer other generic alternatives,
  • product availability and pricing can shift even without complete launch blocking.
• Settlement agreements often create time-bound launch schedules, but revenue recovery is usually limited once broad substitution begins.

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What is the biosimilar risk for LYRICA CR?

Quick answer: Biosimilar risk is not applicable to pregabalin tablets. The competitive threat is generic small-molecule substitution, not biologics.

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What formulation and method-of-use patent strategies exist for pregabalin extended-release?

Quick answer: Patent strategy in pregabalin typically includes:

• extended-release formulation patents,
• manufacturing/solid-state or composition claims,
• method-of-use claims tied to dosing regimens or indications.

Commercial relevance

Even when formulation or use patents exist, the ability to maintain revenue depends on:

• enforceable, timely exclusivity,
• payer willingness to reimburse the brand at competitive net pricing.

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What regulatory and FDA pathway issues matter for generic entry of pregabalin tablets?

Quick answer: Generic entry is typically governed by ANDA submissions for the small molecule active ingredient, with bioequivalence showing relative exposure to the reference product.

Practical entry constraints

• Bioequivalence
• Manufacturing quality
• Label alignment These determine launch feasibility and speed, not long-term brand retention once generics are numerous.

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How should investors model LYRICA CR revenue: base case, downside, and bull case?

Quick answer: Model LYRICA CR as a maturing branded CNS product with continued share erosion; net sales trend should be driven by contracting intensity, generic supply expansion, and wholesale destocking cycles.

Base case

• steady unit decline,
• net price compression,
• modest sequential volatility from inventory.

Downside

• additional PBM formulary narrowing,
• stronger rebate pressure,
• accelerated conversion of new patients to generics.

Bull case

• temporary access stabilization via contracting,
• brand retention among stabilized patients,
• slower competitive response in certain channels.

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Key Takeaways

• LYRICA CR’s market dynamics are dominated by generic pregabalin substitution and net price erosion through PBM contracting.
• The financial trajectory is consistent with a late-stage branded CNS profile: revenue contraction with persistent margin pressure.
• Exclusive differentiation tied to extended-release has reduced impact as formularies and patient behavior increasingly follow cost and access rules rather than formulation preference.
• Competitive risk is structurally ongoing through generic availability, not biologics or biosimilar pathways.

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FAQs

1. What drives net sales more for LYRICA CR, units or net price?
   Generic penetration generally makes net price and net reimbursement terms the larger driver of brand net sales decline.

2. How do PBM formulary decisions typically change pregabalin brand share?
   Formulary tier shifts to preferred generics usually cause fast pharmacy claim migration, shrinking branded volume.

3. Does wholesaler inventory destocking affect LYRICA CR quarterly results?
   Yes. Inventory cycles can create quarter-to-quarter swings even when underlying demand is stable.

4. Is extended-release pregabalin protected by a unique competitive barrier versus immediate-release generics?
   The clinical differentiation can maintain limited stabilized-patient share, but it rarely prevents continued payer-driven substitution.

5. Are there biosimilar threats to LYRICA CR?
   No. Pregabalin is a small molecule; the competitive threat is ANDA generics, not biosimilars.

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References (APA)

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. IQVIA Institute reports and drug market insights (latest available publications). IQVIA. https://www.iqvia.com/insights/the-iqvia-institute
3. U.S. FDA ANDA bioequivalence guidance for generic drug approvals. U.S. Food and Drug Administration. https://www.fda.gov/