IBUPROFEN Drug Patent Profile
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When do Ibuprofen patents expire, and when can generic versions of Ibuprofen launch?
Ibuprofen is a drug marketed by Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, P And L Dev Llc, Sofgen Pharms, Strides Pharma, Guardian Drug, L Perrigo Co, Tris Pharma Inc, Actavis Mid Atlantic, Akorn, Aptapharma Inc, Arise, P And L, Padagis Us, Taro, Perrigo, Abbott, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, J And J Consumer Inc, Lederle, Leiner, LNK, Mcneil, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Pliva, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Sun Pharm Industries, Sunshine, Superpharm, Teva, Ultratab Labs Inc, Vintage Pharms, Watson Labs, Yichang Humanwell, Dr Reddys Labs Ltd, Teva Pharms Usa, and Xgen Pharms. and is included in one hundred and seventy-one NDAs.
The generic ingredient in IBUPROFEN is ibuprofen sodium. There are sixty-four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibuprofen sodium profile page.
Summary for IBUPROFEN
Recent Clinical Trials for IBUPROFEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hackensack Meridian Health | Early Phase 1 |
| Guangzhou Kangqi Medical Technology Co., LTD | Phase 1 |
| Novo Nordisk A/S | Phase 1 |
Pharmacology for IBUPROFEN
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for IBUPROFEN
Anatomical Therapeutic Chemical (ATC) Classes for IBUPROFEN
Paragraph IV (Patent) Challenges for IBUPROFEN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PEDIATRIC ADVIL | Oral Suspension | ibuprofen | 50 mg/1.25 mL | 020812 | 1 | 2007-06-29 |
US Patents and Regulatory Information for IBUPROFEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Granules | IBUPROFEN | ibuprofen | TABLET;ORAL | 091625-003 | Sep 15, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Merro Pharm | IBUPROFEN | ibuprofen | TABLET;ORAL | 070985-001 | Oct 2, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amneal Pharms Ny | IBUPROFEN | ibuprofen | TABLET;ORAL | 078558-002 | Jun 18, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alkem Labs Ltd | IBUPROFEN | ibuprofen | TABLET;ORAL | 214699-001 | Sep 13, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Vintage Pharms | IBUPROFEN | ibuprofen | TABLET;ORAL | 071229-001 | Apr 1, 1987 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for IBUPROFEN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare Diseases | Pedea | ibuprofen | EMEA/H/C/000549 Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age. |
Authorised | no | no | no | 2004-07-28 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
