DrugPatentWatch Database Preview
Pregabalin - Generic Drug Details
What are the generic sources for pregabalin and what is the scope of patent protection?
Pregabalin
is the generic ingredient in three branded drugs marketed by Upjohn, Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Celltrion, Changzhou Pharm, Cipla, Cspc Ouyi, Dr Reddys, Hetero Labs Ltd Iii, Hikal, Invagen Pharms, MSN, Mylan, Rising, Sciegen Pharms Inc, Shuangcheng, Sun Pharm, Teva Pharms, Alvogen, and Alvogen Pine Brook, and is included in thirty-two 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-seven suppliers are listed for this compound. There are thirteen tentative approvals for this compound.
Summary for pregabalin
| International Patents: | 37 |
| US Patents: | 3 |
| Tradenames: | 3 |
| Applicants: | 23 |
| NDAs: | 32 |
| Drug Master File Entries: | 41 |
| Finished Product Suppliers / Packagers: | 37 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 474 |
| Patent Applications: | 7,725 |
| 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 |
|---|---|
| Beijing Tiantan Hospital | Phase 2/Phase 3 |
| Thomas Jefferson University | Phase 3 |
| Alexandria University | Phase 2 |
Generic filers with tentative approvals for PREGABALIN
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try it Free | ⤷ Try it Free | 75MG | CAPSULE;ORAL |
| ⤷ Try it Free | ⤷ Try it Free | 50MG | CAPSULE;ORAL |
| ⤷ Try it Free | ⤷ Try it Free | 25MG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msn | PREGABALIN | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 213226-002 | Apr 13, 2021 | AB | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Rising | PREGABALIN | pregabalin | CAPSULE;ORAL | 210432-006 | Jul 19, 2019 | AB | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Amneal Pharms Co | PREGABALIN | pregabalin | CAPSULE;ORAL | 209743-003 | Jul 19, 2019 | AB | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| >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 | 021446-008 | Dec 30, 2004 | ⤷ Try it Free | ⤷ Try it Free |
| Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | ⤷ Try it Free | ⤷ Try it Free |
| Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pregabalin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20080059427 | ⤷ Try it Free |
| Netherlands | 2000281 | ⤷ Try it Free |
| Ecuador | SP088422 | ⤷ Try it Free |
| >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 | ⤷ Try it Free | 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 | SPC/GB04/034 | United Kingdom | ⤷ Try it Free | 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 | ⤷ Try it Free | PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
