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Last Updated: June 14, 2025

Pregabalin - Generic Drug Details


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What are the generic sources for pregabalin and what is the scope of patent protection?

Pregabalin is the generic ingredient in three branded drugs marketed by Upjohn, Actavis Elizabeth, Adaptis, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Eskayef, Hetero Labs Ltd Iii, Hlthcare, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Norvium Bioscience, Prinston Inc, Renata, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Teva Pharms, Torrent, Yiling, Zydus Pharms, Anda Repository, Alvogen, Epic Pharma Llc, Hq Pharma, and Rubicon, and is included in fifty-two NDAs. There are three patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pregabalin has thirty-seven patent family members in thirty-three countries.

There are forty-one drug master file entries for pregabalin. Fifty-three suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for pregabalin

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Drug Sales Revenue Trends for pregabalin

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Recent Clinical Trials for pregabalin

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

SponsorPhase
Jules Bordet InstitutePhase 2
University of MilanPhase 2
KU LeuvenPhase 2

See all pregabalin clinical trials

Generic filers with tentative approvals for PREGABALIN
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free300MGCAPSULE;ORAL
⤷  Try for Free⤷  Try for Free225MGCAPSULE;ORAL
⤷  Try for Free⤷  Try for Free200MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for pregabalin
Paragraph IV (Patent) Challenges for PREGABALIN
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
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 pregabalin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex PREGABALIN pregabalin CAPSULE;ORAL 211685-008 Jul 7, 2021 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Amneal Pharms Co PREGABALIN pregabalin CAPSULE;ORAL 209743-005 Jul 19, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alembic PREGABALIN pregabalin CAPSULE;ORAL 203459-003 Jul 19, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for pregabalin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 5,563,175 ⤷  Try for Free
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 5,563,175 ⤷  Try for Free
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-003 Dec 30, 2004 5,563,175 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for pregabalin

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for pregabalin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 2004C/022 Belgium ⤷  Try for Free PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0641330 27/2004 Austria ⤷  Try for Free 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 SPC/GB04/034 United Kingdom ⤷  Try for Free 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/
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory of Pregabalin

Introduction to Pregabalin

Pregabalin, an anticonvulsant and anxiolytic drug, is widely used for the management of various neurological and psychiatric conditions, including neuropathic pain, epilepsy, fibromyalgia, and generalized anxiety disorder. Understanding the market dynamics and financial trajectory of pregabalin is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth

The global pregabalin market has been experiencing steady growth, driven by several key factors. As of 2022, the market size was valued at $1.6 billion and is projected to reach $2.2 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3% from 2023 to 2032[1][3].

Key Drivers of Market Growth

Increasing Prevalence of Neurological Conditions

The rise in the number of cases of epilepsy, neuropathic pain, and anxiety disorders is a significant driver of the pregabalin market. According to the World Health Organization (WHO), epilepsy affects over 50 million individuals worldwide, with a substantial portion of these individuals not receiving the necessary therapy, especially in low-income countries[1].

Generic Approvals and Cost-Effectiveness

The surge in approvals of generic pregabalin products has increased accessibility and affordability, particularly in developing and underdeveloped economies. Generic pregabalin offers a cost-effective alternative, boosting market expansion in these regions[1][3].

Advancements in Healthcare Infrastructure

Regions like Asia-Pacific are witnessing rapid developments in healthcare infrastructure, which includes increased investments in research and development (R&D) and the presence of domestic market players. These factors are expected to drive the market growth in these regions[1][3].

Regional Market Insights

North America

North America dominated the global pregabalin market in terms of revenue in 2022, thanks to its advanced healthcare infrastructure, substantial investments in R&D, and the presence of major industry players. However, the region's growth rate is expected to be outpaced by other regions in the coming years[1][4].

Asia-Pacific

Asia-Pacific is anticipated to register the fastest CAGR during the forecast period. This growth is attributed to the rising patient population suffering from epilepsy, neuropathic pain, and other conditions, along with significant investments in healthcare and R&D activities. Countries such as China, India, and Southeast Asian nations are driving this growth[1][3].

Competitive Analysis

The pregabalin market is highly competitive, with several key players operating globally. The market has seen significant growth driven by the rise in target population and the growing pharmaceutical industry. The increase in prevalence of neuropathic pain, epilepsy, and anxiety, coupled with the rise in generic approvals of pregabalin products, has driven demand across the globe[1][3].

Product Development and Innovation

Unique Formulations

Efforts to develop unique formulations of pregabalin are providing new opportunities for market participants. These innovative approaches aim to produce products with higher efficacies, further boosting market expansion[1].

Contract Manufacturing

The rise in contract manufacturing organizations, especially in the Asia-Pacific region, offers great opportunities for new entrants and existing players to expand their market presence[1].

Pharmacological and Clinical Aspects

Mechanism of Action

Pregabalin is known for its rapid absorption and high bioavailability, regardless of the dose. It crosses the blood-brain barrier via System L transporters and is primarily excreted unchanged in the urine[2].

Adverse Effects

Common adverse effects associated with pregabalin include vertigo, dizziness, balance disorder, and somnolence. Despite these side effects, pregabalin remains a crucial treatment option for various neurological conditions[2].

Financial Trajectory

The financial trajectory of the pregabalin market is promising, with steady growth expected over the next decade. Here are some key financial projections:

  • Market Size: Expected to reach $2.2 billion by 2032 from $1.6 billion in 2022[1].
  • CAGR: Projected to grow at a CAGR of 3% from 2023 to 2032[1].
  • Regional Growth: Asia-Pacific is expected to grow at the fastest pace, while North America will continue to hold a significant market share[1][3].

Challenges and Opportunities

Challenges

Despite the growth, the pregabalin market faces challenges such as the high prevalence of untreated epilepsy in low-income countries and the potential for adverse effects associated with the drug[1][2].

Opportunities

The market offers several opportunities, including the development of generic products, advancements in healthcare infrastructure, and the rise of contract manufacturing organizations. These factors are expected to drive market expansion and provide new business prospects for key industry players[1][3].

Key Takeaways

  • The global pregabalin market is driven by the increasing prevalence of neurological conditions and the rise in generic approvals.
  • Asia-Pacific is expected to register the fastest growth rate due to advancements in healthcare infrastructure and R&D activities.
  • North America continues to dominate the market but is expected to be outpaced by Asia-Pacific in the coming years.
  • Innovative product development and contract manufacturing are key opportunities for market growth.

Frequently Asked Questions

Q: What are the primary applications of pregabalin? A: Pregabalin is primarily used for the management of neuropathic pain, epilepsy, fibromyalgia, and generalized anxiety disorder[2][4].

Q: Which region dominates the global pregabalin market? A: North America currently dominates the global pregabalin market, but Asia-Pacific is expected to grow at the fastest rate during the forecast period[1][3].

Q: What is the projected market size of pregabalin by 2032? A: The global pregabalin market is projected to reach $2.2 billion by 2032[1].

Q: What are the key drivers of the pregabalin market growth? A: The key drivers include the increasing prevalence of neurological conditions, rise in generic approvals, and advancements in healthcare infrastructure[1][3].

Q: What are the common adverse effects associated with pregabalin? A: Common adverse effects include vertigo, dizziness, balance disorder, and somnolence[2].

Sources:

  1. Allied Market Research - Pregabalin Market Size, Segments Analysis | Forecast - 2032
  2. DrugBank - Pregabalin: Uses, Interactions, Mechanism of Action
  3. Spherical Insights - Global Pregabalin Market Size, Share, Forecast 2023 to 2033
  4. Maximize Market Research - Pregabalin Market: Industry Analysis and Forecast (2024-2030)
Last updated: 2024-12-16

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