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PREGABALIN Drug Profile
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When do Pregabalin patents expire, and when can generic versions of Pregabalin launch?
Pregabalin is a drug marketed by 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-one NDAs.
The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pregabalin
A generic version of PREGABALIN was approved as pregabalin by ALEMBIC PHARMS LTD on July 19th, 2019.
Summary for PREGABALIN
| US Patents: | 0 |
| Applicants: | 18 |
| NDAs: | 21 |
| Suppliers / Packagers: | 26 |
| Bulk Api Vendors: | 90 |
| Clinical Trials: | 445 |
| Patent Applications: | 3,947 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
See drug prices for PREGABALIN
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 |
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 | 213423-006 | Mar 23, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Rising | PREGABALIN | pregabalin | CAPSULE;ORAL | 210432-003 | Jul 19, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Cipla | PREGABALIN | pregabalin | CAPSULE;ORAL | 212280-005 | Jan 10, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal Pharms Co | PREGABALIN | pregabalin | CAPSULE;ORAL | 209743-008 | Jul 19, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Msn | PREGABALIN | pregabalin | CAPSULE;ORAL | 209357-004 | Jul 19, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sciegen Pharms Inc | PREGABALIN | pregabalin | CAPSULE;ORAL | 208677-008 | Jul 19, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Cspc Ouyi | PREGABALIN | pregabalin | CAPSULE;ORAL | 210585-005 | Dec 26, 2019 | AB | RX | No | 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 |
