PREGABALIN - Generic Drug Details

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, 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-three 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-five suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for PREGABALIN

International Patents:	37
US Patents:	3
Tradenames:	3
Applicants:	38
NDAs:	53
Drug Master File Entries:	41
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	577
Patent Applications:	6,942
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
McMaster University	PHASE4
Eurofarma Laboratorios S.A.	PHASE3
Tanta University	NA

See all PREGABALIN clinical trials

Generic filers with tentative approvals for PREGABALIN

Applicant	Application No.	Strength	Dosage Form
		300MG	CAPSULE;ORAL
		225MG	CAPSULE;ORAL
		200MG	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
Msn	PREGABALIN	pregabalin	CAPSULE;ORAL	209357-008	Jul 19, 2019	AB	RX	No	No
Jubilant Generics	PREGABALIN	pregabalin	CAPSULE;ORAL	209530-003	May 20, 2025	AB	RX	No	No
Apotex	PREGABALIN	pregabalin	CAPSULE;ORAL	211685-006	Jul 7, 2021		DISCN	No	No
Somerset Theraps Llc	PREGABALIN	pregabalin	CAPSULE;ORAL	210585-003	Dec 26, 2019	AB	RX	No	No
Anda Repository	PREGABALIN	pregabalin	SOLUTION;ORAL	212604-001	Feb 18, 2022	AA	RX	No	No
Hetero Labs Ltd Iii	PREGABALIN	pregabalin	CAPSULE;ORAL	206912-007	Oct 8, 2019	AB	RX	No	No
Sciegen Pharms	PREGABALIN	pregabalin	TABLET, EXTENDED RELEASE;ORAL	215675-002	Sep 14, 2022		DISCN	No	No

Expired US Patents for PREGABALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010	5,563,175
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004	5,563,175
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004	5,563,175
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004	5,563,175
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004	5,563,175
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004	5,563,175
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-002	Dec 30, 2004	5,563,175

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
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 PREGABALIN

Country	Patent Number	Title	Estimated Expiration
Taiwan	200803831	Solid pharmaceutical compositions containing pregabalin
Ecuador	SP088422	COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Serbia	20080181	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)
Dominican Republic	P2006000241	COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Montenegro	00482	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)
Norway	20081816
Japan	4334610

Supplementary Protection Certificates for PREGABALIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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/
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0934061	PA2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0641330	CR 2004 00036	Denmark		PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0641330	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0641330	2004C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708

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.