Ibuprofen - Generic Drug Details
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What are the generic sources for ibuprofen and what is the scope of patent protection?
Ibuprofen
is the generic ingredient in forty-four branded drugs marketed by Haleon Us Holdings, Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, P And L Dev Llc, Patheon Softgels, Sofgen Pharms, Strides Pharma, Bayer, Cumberland Pharms, J And J Consumer Inc, Guardian Drug, L Perrigo Co, Taro, Tris Pharma Inc, Mcneil, Moberg Pharma North, Perrigo, Abbott, Actavis Mid Atlantic, Annora Pharma, Arise, P And L, Padagis Us, Pai Holdings Pharm, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Adaptis, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Endo Operations, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, Leiner, LNK, Merro Pharm, Northstar Hlthcare, Norvium Bioscience, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Sun Pharm Industries, Sunshine, Superpharm, Teva, Ultratab Labs Inc, Watson Labs, Yichang Humanwell, Bristol Myers, Xgen Pharms, Recordati Rare, Forest Labs, Actavis Elizabeth, Barr Labs Inc, and Dr Reddys Labs Ltd, and is included in two hundred and twenty-seven NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ibuprofen has sixty-five patent family members in nineteen countries.
There are sixty-four drug master file entries for ibuprofen. Two hundred and thirty-nine suppliers are listed for this compound.
Summary for ibuprofen
International Patents: | 65 |
US Patents: | 12 |
Tradenames: | 44 |
Applicants: | 75 |
NDAs: | 227 |
Drug Master File Entries: | 64 |
Finished Product Suppliers / Packagers: | 239 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 865 |
Drug Prices: | Drug price trends for ibuprofen |
Drug Sales Revenues: | Drug sales revenues for ibuprofen |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ibuprofen |
What excipients (inactive ingredients) are in ibuprofen? | ibuprofen excipients list |
DailyMed Link: | ibuprofen at DailyMed |
Recent Clinical Trials for ibuprofen
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Michigan | Phase 1/Phase 2 |
California Table Grape Commission | Phase 1/Phase 2 |
University of Nove de Julho | N/A |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Perrigo | IBUPROFEN | ibuprofen | TABLET;ORAL | 072098-001 | Dec 8, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ultratab Labs Inc | IBUPROFEN | ibuprofen | TABLET;ORAL | 209076-001 | Jan 6, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo Pharma Ltd | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | ibuprofen; pseudoephedrine hydrochloride | TABLET;ORAL | 213565-001 | Mar 10, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Halsey | IBUPROFEN | ibuprofen | TABLET;ORAL | 071030-001 | Mar 23, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Halsey | IBUPROFEN | ibuprofen | TABLET;ORAL | 071027-001 | Sep 29, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 ibuprofen
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mcneil Ped | MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020135-001 | Nov 16, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Mcneil Ped | MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020135-001 | Nov 16, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Haleon Us Holdings | CHILDREN'S ADVIL | ibuprofen | SUSPENSION;ORAL | 019833-002 | Sep 19, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Mcneil Ped | MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020135-002 | Nov 16, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Bionpharma | MIDOL LIQUID GELS | ibuprofen | CAPSULE;ORAL | 021472-001 | Oct 18, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for ibuprofen
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 102413687 | Administration of intravenous ibuprofen | ⤷ Sign Up |
Malaysia | 174442 | TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2010105129 | ⤷ Sign Up | |
South Korea | 20120089444 | TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN | ⤷ Sign Up |
Portugal | 2825039 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ibuprofen
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1781277 | PA2024501 | Lithuania | ⤷ Sign Up | PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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