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Last Updated: February 10, 2025

LYRICA CR Drug Patent Profile


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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-four 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 19th, 2019.

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Summary for LYRICA CR
International Patents:37
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 102
Clinical Trials: 161
Patent Applications: 3,989
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
Drug patent expirations by year for LYRICA CR
Drug Prices for LYRICA CR

See drug prices for LYRICA CR

Recent Clinical Trials for LYRICA CR

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

SponsorPhase
University of MiamiPhase 4
Henry Ford Health SystemPhase 4
An-Najah National UniversityPhase 2/Phase 3

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 ⤷  Free Trial Y ⤷  Free Trial
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 AB RX Yes Yes 9,144,559*PED ⤷  Free Trial Y ⤷  Free Trial
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 AB RX Yes No 9,144,559*PED ⤷  Free Trial Y ⤷  Free Trial
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 AB RX Yes Yes 10,022,447*PED ⤷  Free Trial Y ⤷  Free Trial
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 AB RX Yes No 10,022,447*PED ⤷  Free Trial Y ⤷  Free Trial
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 AB RX Yes No 8,945,620*PED ⤷  Free Trial Y ⤷  Free Trial
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 AB RX Yes No 8,945,620*PED ⤷  Free Trial Y ⤷  Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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/004277
Neuropathic 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/003900
Neuropathic 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/003962
EpilepsyPregabalin 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/003880
Neuropathic 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/000546
Neuropathic 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/004070
EpilepsyPregabalin 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/004024
EpilepsyPregabalin 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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:

Argentina

Patent: 8175
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷  Free Trial

Australia

Patent: 06310217
Patent: Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent
Estimated Expiration: ⤷  Free Trial

Brazil

Patent: 0618211
Patent: composição farmacêutica contendo pregabalina e uso do referido composto
Estimated Expiration: ⤷  Free Trial

Canada

Patent: 28200
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSINGCONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷  Free Trial

China

Patent: 1330907
Patent: Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent
Estimated Expiration: ⤷  Free Trial

Costa Rica

Patent: 50
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷  Free Trial

Cyprus

Patent: 15009
Estimated Expiration: ⤷  Free Trial

Denmark

Patent: 45186
Estimated Expiration: ⤷  Free Trial

Dominican Republic

Patent: 006000241
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷  Free Trial

Ecuador

Patent: 088422
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷  Free Trial

Eurasian Patent Organization

Patent: 2377
Patent: ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷  Free Trial

Patent: 0800931
Patent: ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ
Estimated Expiration: ⤷  Free Trial

European Patent Office

Patent: 45186
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES ORALES ADAPTEES A UNE SEULE PRISE PAR JOUR, CONTENANT LA PREGABALINE, UN AGENT MATRICIEL AINSI QU'UN AGENT GONFLANT (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷  Free Trial

Guatemala

Patent: 0600474
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷  Free Trial

Hong Kong

Patent: 26394
Patent: SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT
Estimated Expiration: ⤷  Free Trial

Israel

Patent: 0827
Patent: PHARMACEUTICAL COMPOSITION COMPRISING PREGABALIN AND THE USE OF THE PHARMACEUTICAL COMPOSITION IN THE MANUFACTURE OF A MEDICAMENT
Estimated Expiration: ⤷  Free Trial

Japan

Patent: 34610
Estimated Expiration: ⤷  Free Trial

Patent: 09514847
Estimated Expiration: ⤷  Free Trial

Montenegro

Patent: 482
Patent: ČVRSTE FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE PREGABALIN SREDSTVO ZA FORMIRANJE MATRIKSA I SREDSTVO ZA BUBRENJE (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷  Free Trial

Morocco

Patent: 135
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE
Estimated Expiration: ⤷  Free Trial

Netherlands

Patent: 00281
Patent: Vaste farmaceutische samenstellingen die pregabaline bevatten.
Estimated Expiration: ⤷  Free Trial

New Zealand

Patent: 7414
Patent: Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent
Estimated Expiration: ⤷  Free Trial

Norway

Patent: 081816
Estimated Expiration: ⤷  Free Trial

Peru

Patent: 070693
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷  Free Trial

Poland

Patent: 45186
Estimated Expiration: ⤷  Free Trial

Portugal

Patent: 45186
Estimated Expiration: ⤷  Free Trial

Serbia

Patent: 080181
Patent: ČVRSTE FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE PREGABALIN SREDSTVO ZA FORMIRANJE MATRIKSA I SREDSTVO ZA BUBRENJE (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷  Free Trial

Slovenia

Patent: 45186
Estimated Expiration: ⤷  Free Trial

South Africa

Patent: 0803115
Patent: Solid pharmaceutical compositions containing pregabalin
Estimated Expiration: ⤷  Free Trial

South Korea

Patent: 1012533
Estimated Expiration: ⤷  Free Trial

Patent: 080059427
Patent: SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT
Estimated Expiration: ⤷  Free Trial

Spain

Patent: 49231
Estimated Expiration: ⤷  Free Trial

Taiwan

Patent: 30080
Estimated Expiration: ⤷  Free Trial

Patent: 0803831
Patent: Solid pharmaceutical compositions containing pregabalin
Estimated Expiration: ⤷  Free Trial

Tunisia

Patent: 08194
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE
Estimated Expiration: ⤷  Free Trial

Uruguay

Patent: 890
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷  Free Trial

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
Israel 190827 PHARMACEUTICAL COMPOSITION COMPRISING PREGABALIN AND THE USE OF THE PHARMACEUTICAL COMPOSITION IN THE MANUFACTURE OF A MEDICAMENT ⤷  Free Trial
Hungary 9702482 ⤷  Free Trial
Dominican Republic P2006000241 COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA ⤷  Free Trial
Hong Kong 1021134 ⤷  Free Trial
Japan 3856816 ⤷  Free Trial
Israel 126999 PHARMACEUTICAL COMPOSITIONS CONTAINING ISOBUTYLGABA AND ITS DERIVATIVES FOR USE IN THE TREATMENT OF PAIN ⤷  Free Trial
Norway 2008018 ⤷  Free Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LYRICA CR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 SPC016/2004 Ireland ⤷  Free Trial SPC016/2004: 20050803, EXPIRES: 20180517
0641330 91112 Luxembourg ⤷  Free Trial 91112, EXPIRES: 20180518
0641330 CR 2004 00036 Denmark ⤷  Free Trial PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0641330 27/2004 Austria ⤷  Free Trial 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 2004C/022 Belgium ⤷  Free Trial PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0641330 C00641330/01 Switzerland ⤷  Free Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0934061 PA2004017 Lithuania ⤷  Free Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for LYRICA CR (Pregabalin)

Introduction

LYRICA CR, the extended-release formulation of pregabalin, is a significant player in the pharmaceutical market, particularly in the treatment of neuropathic pain conditions. Here, we delve into the market dynamics and financial trajectory of LYRICA CR, exploring its approval, market performance, and future projections.

FDA Approval and Clinical Significance

LYRICA CR was approved by the U.S. FDA in October 2017 for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and postherpetic neuralgia (PHN)[1].

  • The approval was based on a randomized placebo-controlled clinical trial involving 801 patients with PHN, which demonstrated that 73.6% of patients in the LYRICA CR group achieved at least 50% improvement in pain intensity compared to 54.6% in the placebo group.

Market Performance

Initial Success and Peak Sales

LYRICA, the brand name for pregabalin, has had a robust market presence since its initial approval. In its first full year on the market in 2006, LYRICA generated sales of about $1.2 billion[3].

  • The drug's success was a boon for Northwestern University, which held the patents and copyrights for the drug, earning significant licensing income.

Impact of Patent Expiry

The financial performance of LYRICA CR has been influenced by the loss of exclusivity for the original LYRICA formulation. In July 2019, Pfizer lost U.S. exclusivity for LYRICA, leading to a decline in revenues for the Upjohn segment of Pfizer[2].

  • This decline was reflected in Pfizer's financial results, with Upjohn revenues decreasing by 16% operationally in 2019, primarily due to the loss of exclusivity for LYRICA in the U.S.

Financial Trajectory

Revenue Trends

The revenue from LYRICA has been a significant contributor to Pfizer's overall financial performance. However, with the loss of exclusivity, the revenue has seen a decline.

  • In 2019, the cost of sales as a percentage of revenues increased partly due to lower LYRICA revenues in developed markets[2].

Segment Performance

Pfizer's Biopharma segment, which includes newer and more innovative drugs, has shown strong growth, offsetting some of the decline from the Upjohn segment.

  • Despite the decline in Upjohn revenues, Pfizer's overall financial results for 2019 were positive, with the Biopharma segment driving operational revenue growth of 8%[2].

Global Pregabalin Market Outlook

Market Size and Growth

The global pregabalin market, which includes LYRICA CR, was valued at $1.6 billion in 2022 and is projected to reach $2.2 billion by 2032, growing at a CAGR of 3% from 2023 to 2032[4].

  • The growth is driven by the increasing prevalence of neuropathic pain, epilepsy, and anxiety, as well as the rise in generic approvals of pregabalin products.

Regional Dynamics

North America dominated the global pregabalin market in terms of revenue in 2022, driven by advanced healthcare infrastructure and substantial investments in R&D. However, the Asia-Pacific region is expected to register the fastest CAGR during the forecast period due to rising healthcare expenditures and technological advancements[4].

Distribution Channels

The drug stores and retail pharmacies segment dominated the market share in terms of revenue in 2022, while the online providers segment is anticipated to grow at the fastest CAGR during the forecast period[4].

Competitive Landscape

Generic Competition

The approval of generic pregabalin products has increased competition in the market. Despite this, LYRICA CR's extended-release formulation offers a convenience of once-daily dosing, which can be a differentiator in the market[1].

Pricing Strategies

Pfizer has faced criticism for price increases, including a 9.4% price hike for LYRICA in January 2016 and another increase in June 2017[5].

  • These pricing strategies have been a subject of debate, with some advocating for more affordable access to essential medications.

Future Projections

Market Expansion

The pregabalin market is expected to grow significantly, driven by the increasing target population suffering from neuropathic pain, epilepsy, and anxiety. Key strategies adopted by market players, such as product launches and expansions into developing and underdeveloped countries, will further boost the market[4].

Technological Advancements

Rapid technological advancements and increased healthcare investments in regions like China, India, and Southeast Asia are expected to contribute to the market's expansion[4].

Key Takeaways

  • FDA Approval: LYRICA CR was approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.
  • Market Performance: The drug's success was significant, but revenues declined after the loss of exclusivity for the original LYRICA formulation.
  • Financial Trajectory: Pfizer's overall financial performance has been impacted by the decline in Upjohn revenues, but the Biopharma segment has shown strong growth.
  • Global Market Outlook: The global pregabalin market is projected to grow at a CAGR of 3% from 2023 to 2032, driven by increasing prevalence of target conditions and generic approvals.
  • Regional Dynamics: North America currently dominates the market, but Asia-Pacific is expected to grow at the fastest CAGR.

FAQs

What is LYRICA CR used for?

LYRICA CR is used for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and postherpetic neuralgia (PHN)[1].

How has the loss of exclusivity affected LYRICA CR's revenue?

The loss of exclusivity for the original LYRICA formulation in July 2019 led to a significant decline in revenues for Pfizer's Upjohn segment[2].

What is the projected growth rate of the global pregabalin market?

The global pregabalin market is projected to grow at a CAGR of 3% from 2023 to 2032[4].

Which region is expected to grow the fastest in the pregabalin market?

The Asia-Pacific region is expected to register the fastest CAGR during the forecast period due to rising healthcare expenditures and technological advancements[4].

How has the approval of generic pregabalin products impacted the market?

The approval of generic pregabalin products has increased competition but also driven the demand for pregabalin across the globe, particularly in developing and underdeveloped countries[4].

Sources

  1. Pfizer Inc. - U.S. FDA Approves LYRICA® CR (pregabalin) Extended-Release Tablets CV[1].
  2. Pfizer Inc. - Pfizer Reports Fourth-Quarter and Full-Year 2019 Results[2].
  3. Daily Northwestern - As Lyrica profits dry up, Northwestern seeks another 'blockbuster' drug[3].
  4. Allied Market Research - Pregabalin Market Size, Segments Analysis | Forecast - 2032[4].
  5. National Prescription Coverage Coalition - Act Now - Block Lyrica CR[5].

More… ↓

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