Pregabalin - Generic Drug Details
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What are the generic drug sources for pregabalin and what is the scope of freedom to operate?
Pregabalin
is the generic ingredient in three branded drugs marketed by Upjohn, Acme Labs, 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, Hetero Labs Ltd Iii, Invagen Pharms, Lupin Ltd, MSN, Norvium Bioscience, Prinston Inc, Rising, Rk Pharma, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Teva Pharms, Yiling, Zydus Pharms, Anda Repository, Alvogen, Epic Pharma Llc, and Rubicon, and is included in forty-eight 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-six suppliers are listed for this compound. There are eight tentative approvals for this compound.
Summary for pregabalin
| International Patents: | 37 |
| US Patents: | 3 |
| Tradenames: | 3 |
| Applicants: | 33 |
| NDAs: | 48 |
| Drug Master File Entries: | 41 |
| Finished Product Suppliers / Packagers: | 56 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 526 |
| Patent Applications: | 5,897 |
| 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 |
Recent Clinical Trials for pregabalin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Milan | Phase 2 |
| KU Leuven | Phase 2 |
| Jules Bordet Institute | Phase 2 |
Generic filers with tentative approvals for PREGABALIN
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
Anatomical Therapeutic Chemical (ATC) Classes for pregabalin
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rising | PREGABALIN | pregabalin | CAPSULE;ORAL | 210432-002 | Jul 19, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Creekwood Pharms | PREGABALIN | pregabalin | CAPSULE;ORAL | 213423-001 | Mar 23, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | PREGABALIN | pregabalin | CAPSULE;ORAL | 091157-004 | Nov 29, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msn | PREGABALIN | pregabalin | CAPSULE;ORAL | 209357-005 | Jul 19, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | PREGABALIN | pregabalin | CAPSULE;ORAL | 207799-003 | Jul 19, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Adaptis | PREGABALIN | pregabalin | CAPSULE;ORAL | 216197-001 | Jul 18, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 pregabalin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-005 | Dec 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-008 | Dec 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-007 | Dec 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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/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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for pregabalin
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2009514847 | ⤷ Sign Up | |
| Morocco | 30135 | COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE | ⤷ Sign Up |
| Poland | 1945186 | ⤷ Sign Up | |
| Taiwan | I330080 | ⤷ Sign Up | |
| Canada | 2628200 | COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSINGCONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT) | ⤷ Sign Up |
| Costa Rica | 9950 | COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for pregabalin
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0934061 | PA2004017,C0934061 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725 |
| 0641330 | 2004C/022 | Belgium | ⤷ Sign Up | PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708 |
| 0641330 | 27/2004 | Austria | ⤷ Sign Up | PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706 |
| 0934061 | PA2004017 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS) |
| 0641330 | C300164 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706 |
| 0641330 | CR 2004 00036 | Denmark | ⤷ Sign Up | PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
