Pregabalin - Generic Drug Details

What are the generic drug sources for pregabalin and what is the scope of freedom to operate?

Pregabalin is the generic ingredient in three branded drugs marketed by Upjohn, Acme Labs, 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, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Norvium Bioscience, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Teva Pharms, Yiling, Zydus Pharms, Anda Repository, Alvogen, Epic Pharma Llc, and Rubicon, and is included in forty-nine 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-one suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for pregabalin

International Patents:	37
US Patents:	3
Tradenames:	3
Applicants:	34
NDAs:	49
Drug Master File Entries:	41
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	526
Patent Applications:	5,788
Drug Prices:	Drug price trends for pregabalin
Drug Sales Revenues:	Drug sales revenues for pregabalin
What excipients (inactive ingredients) are in pregabalin?	pregabalin excipients list
DailyMed Link:	pregabalin at DailyMed

See drug prices for pregabalin

See drug sales revenues for pregabalin

Recent Clinical Trials for pregabalin

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

Sponsor	Phase
Jules Bordet Institute	Phase 2
University of Milan	Phase 2
KU Leuven	Phase 2

See all pregabalin clinical trials

Generic filers with tentative approvals for PREGABALIN

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE;ORAL
		75MG	CAPSULE;ORAL
		50MG	CAPSULE;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

Analgesics

Anti-Anxiety Agents

Anticonvulsants

Calcium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for pregabalin

N02BF	Gabapentinoids
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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
Changzhou Pharm	PREGABALIN	pregabalin	CAPSULE;ORAL	214322-008	Sep 26, 2024	AB	RX	No	No
Hetero Labs Ltd Iii	PREGABALIN	pregabalin	CAPSULE;ORAL	206912-004	Oct 8, 2019	AB	RX	No	No
Invagen Pharms	PREGABALIN	pregabalin	CAPSULE;ORAL	211384-007	Jul 19, 2019	AB	RX	No	No
Amneal Pharms Co	PREGABALIN	pregabalin	CAPSULE;ORAL	209743-008	Jul 19, 2019	AB	RX	No	No
Apotex	PREGABALIN	pregabalin	CAPSULE;ORAL	211685-005	Jul 7, 2021	AB	RX	No	No

Expired US Patents for pregabalin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-002	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004

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
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

International Patents for pregabalin

Country	Patent Number	Title	Estimated Expiration
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)
Eurasian Patent Organization	200800931	ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ
China	101330907	Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent
Slovenia	1945186
New Zealand	567414	Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent

Supplementary Protection Certificates for pregabalin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330	2004C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
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	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0934061	PA2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)

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)