PREGABALIN Drug Patent Profile

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

Pregabalin is a drug marketed by 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, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Pharmobedient, Prinston Inc, Regcon Holdings, Rising, Sciegen Pharms, Somerset Theraps Llc, Strides Pharma, Sun Pharm, Teva Pharms, Torrent, Yiling, Zydus Pharms, Anda Repository, Aiping Pharm Inc, Alvogen, Epic Pharma Llc, and Rubicon Research. and is included in fifty NDAs.

The generic ingredient in PREGABALIN 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 Pregabalin

A generic version of PREGABALIN was approved as pregabalin by ALEMBIC on July 19^th, 2019.

Summary for PREGABALIN

US Patents:	0
Applicants:	37
NDAs:	50
Finished Product Suppliers / Packagers:	52
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	577
Patent Applications:	3,953
Drug Prices:	Drug price information 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
McMaster University	PHASE4
Eurofarma Laboratorios S.A.	PHASE3
Tanta University	NA

See all PREGABALIN clinical trials

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	214322-007	Jul 15, 2021	AB	RX	No	No
Teva Pharms	PREGABALIN	pregabalin	CAPSULE;ORAL	091219-001	Jul 19, 2019		DISCN	No	No
Eskayef	PREGABALIN	pregabalin	CAPSULE;ORAL	212988-001	Mar 8, 2022	AB	RX	No	No

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/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

Market Dynamics and Financial Trajectory for Pregabalin

Last updated: March 18, 2026

What is the current market size for Pregabalin?

Pregabalin, marketed as Lyrica by Pfizer, generated approximately $3.4 billion in global sales in 2022. The drug primarily targets neuropathic pain, epilepsy, and generalized anxiety disorder.

Region	2022 Sales	Market Share (%)	Key Competitors
United States	$1.8 billion	53	Gabapentin, Eslicarbazepine
Europe	$800 million	24	Gabapentin, Duloxetine
Asia-Pacific	$600 million	18	Generic formulations
Rest of World	$200 million	5	Local generics

How does the patent landscape influence the market?

Pfizer’s original patent for Pregabalin expires in the US in 2018, with subsequent patents for formulations expiring into the early 2020s. Patent expirations have led to a surge of generic versions, reducing prices and market share for branded Lyrica.

• US Pfizer patent expiry: 2018
• US generics entry: 2019–2020
• Market decline for branded Lyrica: 10–15% annually after patent expiry
• EU patent expiry: 2019 for certain formulations

What are the key drivers of market growth?

Market growth for Pregabalin hinges on several factors:

• Unmet needs in neuropathic pain, especially diabetic peripheral neuropathy
• Off-label uses, such as social anxiety disorder
• Expanded indications approved in some countries, like postherpetic neuralgia
• Increasing prevalence of chronic pain and epilepsy globally

How are market players responding?

Major pharmaceutical companies are shifting toward generics, biosimilars, or alternative therapies:

• Pfizer's exit from gig markets in certain regions
• Development of extended-release and combination formulations
• Investment in pipeline drugs for similar indications, e.g., gabapentin derivatives
• Focus on markets with patent protection, such as Japan and emerging economies

What is the outlook for regulatory and reimbursement policies?

Regulatory agencies impact market trajectory through patent protections, approvals, and reimbursement policies. Key points:

• US FDA's approval processes: fast-track options for new formulations
• European regulations favor generic substitution post-patent expiry
• Reimbursement reductions in some regions due to cost-containment efforts
• Increasing scrutiny of off-label prescribing impacting sales

What are the financial projections for Pregabalin?

Forecasts indicate declining revenues in main markets due to generics. But growth in emerging markets and off-label use may counteract some decline.

Year	Projected Global Sales	CAGR (2023–2027)	Notes
2023	$2.8 billion	-5%	Post-patent expiry decline
2025	$2.5 billion	-7% annually	Continued generic penetration
2027	$2.2 billion		Potential stabilizers in emerging markets

How do generic formulations affect overall market revenue?

Generic versions have driven prices down by 50–70%, leading to substantial revenue loss for originator companies. The entry of biosimilar-like formulations or novel delivery mechanisms may offer new revenue streams, but their impact remains limited in the immediate term.

Summary

Pregabalin faces a mature market with declining revenues in developed countries due to patent expiration and generic competition. Growth opportunities concentrate in emerging markets and off-label therapeutic uses. Competitive strategies include formulation innovation and pipeline development. Regulatory and reimbursement policies significantly influence future market dynamics.

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Key Takeaways

• Global sales declined from peak over $3.4 billion in 2022 due to patent expiries.
• Generic competition has reduced average prices by over 50%.
• Market growth prospects shift toward emerging economies and off-label uses.
• Patent expirations in key markets have prompted strategic shifts among manufacturers.
• New formulation development and pipeline drugs aim to sustain revenue streams.

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FAQs

1. When did Pregabalin lose patent protection in the US?
Pfizer’s primary patent for Pregabalin expired in 2018, leading to widespread generic entry starting in 2019.

2. How much revenue has Pfizer lost due to generics?
Pfizer's branded sales declined by approximately 70% post-2018 patent expiry, accounting for billions in revenue loss.

3. Are there new formulations of Pregabalin being developed?
Yes; companies are exploring extended-release versions and combination therapies to differentiate products and extend market life.

4. What are the main off-label uses impacting sales?
Chronic pain, social anxiety disorder, and other neurological conditions contribute to off-label prescribing.

5. How do reimbursement policies affect Pregabalin markets?
Reimbursement reductions in certain regions decrease formulary inclusion, impacting sales volume and pricing strategies.

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Sources

1. Pfizer Inc. (2023). Lyrica sales report.
2. IQVIA. (2022). Global pharmaceutical market analysis.
3. U.S. Food and Drug Administration. (2018). Patent expiration notices.
4. European Medicines Agency. (2019). Regulatory updates on Pregabalin.
5. GlobalData. (2023). Market forecasts for neuropathic pain therapies.