LYRICA Drug Patent Profile
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When do Lyrica patents expire, and what generic alternatives are available?
Lyrica is a drug marketed by Upjohn and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in LYRICA 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
A generic version of LYRICA was approved as pregabalin by ALEMBIC on July 19th, 2019.
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Questions you can ask:
- What is the 5 year forecast for LYRICA?
- What are the global sales for LYRICA?
- What is Average Wholesale Price for LYRICA?
Summary for LYRICA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 101 |
Clinical Trials: | 161 |
Patent Applications: | 3,989 |
Drug Prices: | Drug price information for LYRICA |
Drug Sales Revenues: | Drug sales revenues for LYRICA |
What excipients (inactive ingredients) are in LYRICA? | LYRICA excipients list |
DailyMed Link: | LYRICA at DailyMed |
Recent Clinical Trials for LYRICA
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 |
Paragraph IV (Patent) Challenges for LYRICA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
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 LYRICA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | AB | RX | Yes | Yes | 8,945,620*PED | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-007 | Dec 30, 2004 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-001 | Oct 11, 2017 | AB | RX | Yes | No | 8,945,620*PED | ⤷ Subscribe | Y | ⤷ Subscribe | ||
>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 LYRICA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-007 | Dec 30, 2004 | 5,563,175 | ⤷ Subscribe |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | 5,563,175 | ⤷ Subscribe |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-006 | Dec 30, 2004 | 5,563,175 | ⤷ Subscribe |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-008 | Dec 30, 2004 | 5,563,175 | ⤷ Subscribe |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-005 | Dec 30, 2004 | 5,563,175 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LYRICA
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for LYRICA
See the table below for patents covering LYRICA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20000068015 | ⤷ Subscribe | |
Australia | 714980 | ⤷ Subscribe | |
China | 1094757 | ⤷ Subscribe | |
Hungary | T71522 | ⤷ Subscribe | |
Australia | 3602497 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LYRICA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0934061 | PA2004017,C0934061 | Lithuania | ⤷ Subscribe | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725 |
0641330 | C00641330/01 | Switzerland | ⤷ Subscribe | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
0641330 | 300164 | Netherlands | ⤷ Subscribe | 300164, 20130518, EXPIRES: 20180517 |
0641330 | 2004C/022 | Belgium | ⤷ Subscribe | PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708 |
0641330 | CA 2004 00036 | Denmark | ⤷ Subscribe | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
LYRICA Market Analysis and Financial Projection Experimental
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