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 Glaxosmithkline, 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, Bayer, Cumberland Pharms, J And J Consumer Inc, Guardian Drug, L Perrigo Co, Tris Pharma Inc, Mcneil, Moberg Pharma North, Perrigo, Abbott, Actavis Mid Atlantic, Akorn, Aptapharma Inc, Arise, P And L, Padagis Us, Taro, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, 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 NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ibuprofen has sixty-four patent family members in nineteen countries.
There are sixty-four drug master file entries for ibuprofen. Two hundred and seven suppliers are listed for this compound.
Summary for ibuprofen
International Patents: | 64 |
US Patents: | 11 |
Tradenames: | 44 |
Applicants: | 72 |
NDAs: | 220 |
Drug Master File Entries: | 64 |
Finished Product Suppliers / Packagers: | 207 |
Raw Ingredient (Bulk) Api Vendors: | 184 |
Clinical Trials: | 791 |
Patent Applications: | 5,980 |
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 |
---|---|
Eurofarma Laboratorios S.A. | Phase 3 |
Ottawa Hospital Research Institute | Early Phase 1 |
Kyongbo Pharmaceutical | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | ADVIL MIGRAINE LIQUI-GELS | ibuprofen | CAPSULE;ORAL | 020402-002 | Mar 16, 2000 | OTC | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Vintage Pharms | IBUPROFEN | ibuprofen | TABLET;ORAL | 071229-001 | Apr 1, 1987 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Ohm | IBUPROFEN | ibuprofen | TABLET;ORAL | 071163-001 | Jul 15, 1986 | OTC | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Aurobindo Pharma Ltd | IBUPROFEN | ibuprofen | TABLET;ORAL | 213794-003 | May 8, 2020 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Alkem Labs Ltd | IBUPROFEN | ibuprofen | TABLET;ORAL | 214699-003 | Sep 13, 2021 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | CHILDREN'S MOTRIN | ibuprofen | SUSPENSION;ORAL | 020516-001 | Jun 16, 1995 | See Plans and Pricing | See Plans and Pricing |
Mcneil Consumer | MOTRIN | ibuprofen | SUSPENSION;ORAL | 019842-001 | Sep 19, 1989 | See Plans and Pricing | See Plans and Pricing |
J And J Consumer Inc | CHILDREN'S MOTRIN | ibuprofen | SUSPENSION/DROPS;ORAL | 020603-001 | Jun 10, 1996 | See Plans and Pricing | See Plans and Pricing |
Mcneil Ped | MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020135-002 | Nov 16, 1994 | See Plans and Pricing | See Plans and Pricing |
Bionpharma Inc | MIDOL LIQUID GELS | ibuprofen | CAPSULE;ORAL | 021472-001 | Oct 18, 2002 | See Plans and Pricing | See Plans and Pricing |
>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 | 101864559 | See Plans and Pricing | |
South Korea | 20170091775 | 정맥 내 투여용 이부프로펜의 투여 (ADMINISTRATION OF INTRAVENOUS IBUPROFEN) | See Plans and Pricing |
South Korea | 20120138229 | TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN | See Plans and Pricing |
Australia | 2009350474 | Treating critically ill patients with intravenous ibuprofen | See Plans and Pricing |
Australia | 2010224063 | Administration of intravenous ibuprofen | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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