LYRICA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Lyrica, and when can generic versions of Lyrica launch?
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-one 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.
Summary for LYRICA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 101 |
Clinical Trials: | 157 |
Patent Applications: | 4,098 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Henry Ford Health System | Phase 4 |
An-Najah National University | Phase 2/Phase 3 |
Mylan Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for LYRICA
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-007 | Dec 30, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-001 | Oct 11, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-008 | Dec 30, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>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 | 021446-001 | Dec 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-006 | Dec 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-008 | Dec 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | Dec 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-005 | Dec 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 | |
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 | |
Accord Healthcare S.L.U. | Pregabalin Accord | pregabalin | EMEA/H/C/004024 EpilepsyPregabalin 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 | |
>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 |
---|---|---|---|
Mexico | 9102241 | ANALOGOS DE GABA Y DE ACIDO L-GLUTAMICO PARA TRATAMIENTO CONTRA ATAQUES. | ⤷ Try a Trial |
Poland | 189872 | ⤷ Try a Trial | |
Japan | 3856816 | ⤷ Try a Trial | |
Norway | 325822 | ⤷ Try a Trial | |
China | 1223574 | ⤷ Try a Trial | |
Japan | H07508288 | ⤷ Try a Trial | |
Hungary | 222339 | S-(+)-4-amino-3-(2-metil-propil)-butánsav, és gyógyászati szempontból elfogadható sói, ezeket tartalmazó gyógyászati készítmények, valamint az (S)-(+)-4-amino-3-(2-metil-propil)-butánsav előállítása (S-(+)-4-AMINO-3-(2-METHYLPROPIL)BUTANOIC ACID, PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF AND PROCESS TO PREPARE THEM AND PHARMACEUTICAL COMPOSITION CONTAINING THEM) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LYRICA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0641330 | C00641330/01 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
0641330 | SPC/GB04/034 | United Kingdom | ⤷ Try a Trial | 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/ |
0641330 | 300164 | Netherlands | ⤷ Try a Trial | 300164, 20130518, EXPIRES: 20180517 |
0641330 | SPC016/2004 | Ireland | ⤷ Try a Trial | SPC016/2004: 20050803, EXPIRES: 20180517 |
0641330 | 2004C/022 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708 |
0641330 | C300164 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706 |
0641330 | CA 2004 00036 | Denmark | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |