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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 Pfizer, Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Celltrion, Cipla, Cspc Ouyi, Dr Reddys, Hetero Labs Ltd Iii, Hikal, Invagen Pharms, MSN, Mylan, Rising, Sciegen Pharms Inc, Shuangcheng, Sun Pharm, and Teva Pharms, and is included in twenty-four 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. Thirty-four suppliers are listed for this compound. There are twelve tentative approvals for this compound.
Summary for pregabalin
International Patents: | 37 |
US Patents: | 3 |
Tradenames: | 3 |
Applicants: | 19 |
NDAs: | 24 |
Drug Master File Entries: | 41 |
Suppliers / Packagers: | 34 |
Bulk Api Vendors: | 90 |
Clinical Trials: | 445 |
Patent Applications: | 6,927 |
Formulation / Manufacturing: | see details |
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 |
---|---|
CAMC Health System | Phase 4 |
Emory University | Phase 4 |
Alexandria University | Phase 2 |
Generic filers with tentative approvals for PREGABALIN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 200MG | CAPSULE;ORAL |
Start Trial | Start Trial | 150MG | CAPSULE;ORAL |
Start Trial | Start Trial | 100MG | 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
Paragraph IV (Patent) Challenges for PREGABALIN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
LYRICA CR | TABLET, EXTENDED RELEASE;ORAL | pregabalin | 209501 | 2018-02-02 |
LYRICA CR | TABLET, EXTENDED RELEASE;ORAL | pregabalin | 209501 | 2018-01-29 |
LYRICA | SOLUTION;ORAL | pregabalin | 022488 | 2010-05-19 |
LYRICA | CAPSULE;ORAL | pregabalin | 021446 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikal | PREGABALIN | pregabalin | CAPSULE;ORAL | 213423-001 | Mar 23, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Alkem Labs Ltd | PREGABALIN | pregabalin | CAPSULE;ORAL | 207799-004 | Jul 19, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-003 | Dec 30, 2004 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-003 | Dec 30, 2004 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-005 | Dec 30, 2004 | AB | RX | Yes | No | Start Trial | Start Trial | Start 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 pregabalin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-003 | Dec 30, 2004 | Start Trial | Start Trial |
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | Start Trial | Start Trial |
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | Start Trial | Start Trial |
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | Dec 30, 2004 | Start Trial | Start Trial |
Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-006 | Dec 30, 2004 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pregabalin
Country | Patent Number | Estimated Expiration |
---|---|---|
Denmark | 1945186 | Start Trial |
Eurasian Patent Organization | 200800931 | Start Trial |
Japan | 2009514847 | Start Trial |
Hong Kong | 1126394 | Start Trial |
Montenegro | 00482 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for pregabalin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0641330 | 27/2004 | Austria | Start Trial | 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,C0934061 | Lithuania | Start Trial | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725 |
0641330 | SPC/GB04/034 | United Kingdom | Start 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 | 2004C/022 | Belgium | Start Trial | PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708 |
0641330 | CR 2004 00036 | Denmark | Start Trial | 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 |