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PREGABALIN Drug Profile
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» See Plans and PricingWhen do Pregabalin patents expire, and when can generic versions of Pregabalin launch?
Pregabalin is a drug marketed by 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 NDAs.
The generic ingredient in PREGABALIN is pregabalin. There are forty-one drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
US ANDA 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
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Recent Clinical Trials for PREGABALIN
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| Sponsor | Phase |
|---|---|
| Our Lady of the Lake Hospital | N/A |
| Louisiana State University Health Sciences Center in New Orleans | N/A |
| Ontario Institute for Cancer Research | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Invagen Pharms | PREGABALIN | pregabalin | CAPSULE;ORAL | 211384-006 | Jul 19, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sciegen Pharms Inc | PREGABALIN | pregabalin | CAPSULE;ORAL | 208677-003 | 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 | |||
| Cipla | PREGABALIN | pregabalin | CAPSULE;ORAL | 212280-004 | Jan 10, 2020 | 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 |
