LYRICA CR Drug Patent Profile

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-five 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 19^th, 2019.

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

See drug prices for LYRICA CR

Recent Clinical Trials for LYRICA CR

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

Sponsor	Phase
University of Miami	Phase 4
Henry Ford Health System	Phase 4
An-Najah National University	Phase 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				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017	AB	RX	Yes	No	10,022,447*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017	AB	RX	Yes	No	8,945,620*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017	AB	RX	Yes	No	9,144,559*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017	AB	RX	Yes	Yes	9,144,559*PED				Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017	AB	RX	Yes	Yes	10,022,447*PED				Y

EU/EMA Drug Approvals for LYRICA CR

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

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

Australia

Brazil

Canada

China

Costa Rica

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Israel

Japan

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Uruguay

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
Croatia	P970387
European Patent Office	1945186	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)
Hong Kong	1126394	SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT
South Africa	200803115	Solid pharmaceutical compositions containing pregabalin
Spain	2200184
World Intellectual Property Organization (WIPO)	9209560

Supplementary Protection Certificates for LYRICA CR

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	C00641330/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0641330	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0641330	CA 2004 00036	Denmark
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330	SPC016/2004	Ireland		SPC016/2004: 20050803, EXPIRES: 20180517

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].