IBUPROFEN - Generic Drug Details
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What are the generic drug sources for ibuprofen and what is the scope of freedom to operate?
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, Aptapharma Inc, Arise, P And L, Padagis Us, Pai Holdings Pharm, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, 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, Leiner, LNK, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Sun Pharm Industries, Sunshine, Superpharm, Teva, Ultratab Labs Inc, Vintage Pharms, 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-six 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-four suppliers are listed for this compound.
Summary for IBUPROFEN
International Patents: | 65 |
US Patents: | 12 |
Tradenames: | 44 |
Applicants: | 74 |
NDAs: | 226 |
Drug Master File Entries: | 64 |
Finished Product Suppliers / Packagers: | 234 |
Raw Ingredient (Bulk) Api Vendors: | 207 |
Clinical Trials: | 842 |
Patent Applications: | 4,417 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Mclean Hospital | Phase 4 |
United States Department of Defense | Phase 4 |
University of Miami | Phase 2 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbott | IBUPROFEN | ibuprofen | TABLET;ORAL | 071264-001 | Jul 25, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-003 | Jan 25, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Forest Labs | COMBUNOX | ibuprofen; oxycodone hydrochloride | TABLET;ORAL | 021378-001 | Nov 26, 2004 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Northstar Hlthcare | IBUPROFEN | ibuprofen | TABLET;ORAL | 078132-003 | Sep 10, 2007 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
J And J Consumer Inc | SINE-AID IB | ibuprofen; pseudoephedrine hydrochloride | TABLET;ORAL | 019899-001 | Dec 31, 1992 | 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 |
Expired US Patents for IBUPROFEN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Haleon Us Holdings | CHILDREN'S ADVIL | ibuprofen | SUSPENSION;ORAL | 019833-002 | Sep 19, 1989 | ⤷ Try a Trial | ⤷ Try a Trial |
Haleon Us Holdings | CHILDREN'S ADVIL | ibuprofen | SUSPENSION;ORAL | 020589-001 | Jun 27, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Mcneil Ped | MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020135-002 | Nov 16, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Bionpharma | MIDOL LIQUID GELS | ibuprofen | CAPSULE;ORAL | 021472-001 | Oct 18, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
South Korea | 20180063901 | 정맥 내 투여용 이부프로펜의 투여 (ADMINISTRATION OF INTRAVENOUS IBUPROFEN) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2011008347 | ⤷ Try a Trial | |
China | 1988893 | Pharmaceutical suspension composition | ⤷ Try a Trial |
Brazil | PI0925034 | Composição farmacêutica intravenosa e respectivos usos. | ⤷ Try a Trial |
China | 106890137 | 可注射布洛芬制剂 (INJECTABLE IBUPROFEN FORMULATION) | ⤷ Try a Trial |
>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 | ⤷ Try a Trial | 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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