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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, Taro, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Amneal Pharms Ny, Ani Pharms Inc, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules, Granules India, Halsey, Hec Pharm, Ivax Sub Teva Pharms, Leiner, LNK, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo Pharms Co, Perrigo R And D, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Sun Pharm Industries, 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 seventeen NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ibuprofen has sixty-two patent family members in eighteen countries.
There are sixty-four drug master file entries for ibuprofen. Two hundred and eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for IBUPROFEN
International Patents: | 62 |
US Patents: | 14 |
Tradenames: | 44 |
Applicants: | 71 |
NDAs: | 217 |
Drug Master File Entries: | 64 |
Suppliers / Packagers: | 208 |
Bulk Api Vendors: | 170 |
Clinical Trials: | 689 |
Patent Applications: | 7,220 |
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 |
DailyMed Link: | IBUPROFEN at DailyMed |
Recent Clinical Trials for IBUPROFEN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Apsen Farmaceutica S.A. | Phase 2 |
Children's Hospital of Fudan University | Phase 4 |
Fraser Health | N/A |
Generic filers with tentative approvals for IBUPROFEN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 800MG; 26.6MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for IBUPROFEN
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for IBUPROFEN
Paragraph IV (Patent) Challenges for IBUPROFEN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
INFANT'S ADVIL | SUSPENSION/DROPS;ORAL | ibuprofen | 020812 | 2007-06-29 |
PEDIATRIC ADVIL | SUSPENSION/DROPS;ORAL | ibuprofen | 020812 | 2007-06-29 |
CHILDREN'S MOTRIN | TABLET, CHEWABLE;ORAL | ibuprofen | 020601 | |
JUNIOR STRENGTH MOTRIN | TABLET, CHEWABLE;ORAL | ibuprofen | 020601 | |
CHILDREN'S MOTRIN | SUSPENSION/DROPS;ORAL | ibuprofen | 020603 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Strides Pharma | IBUPROFEN | ibuprofen | TABLET;ORAL | 206989-001 | Jun 29, 2018 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Basf | IBU | ibuprofen | TABLET;ORAL | 070099-001 | Mar 29, 1985 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Contract Pharmacal | IBUPROFEN | ibuprofen | TABLET;ORAL | 074931-001 | Jul 20, 1998 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Strides Pharma | IBUPROFEN | ibuprofen | TABLET;ORAL | 078329-001 | Feb 5, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Sofgen Pharms | IBUPROFEN | ibuprofen | CAPSULE;ORAL | 203599-001 | Sep 7, 2016 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Humanwell Puracap | IBUPROFEN | ibuprofen | CAPSULE;ORAL | 206568-001 | Jun 21, 2016 | OTC | No | No | Start Trial | Start Trial | Start Trial | ||||
Amneal Pharms | IBUPROFEN | ibuprofen | TABLET;ORAL | 079233-001 | Mar 18, 2014 | OTC | 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 |
Expired US Patents for IBUPROFEN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bionpharma Inc | MIDOL LIQUID GELS | ibuprofen | CAPSULE;ORAL | 021472-001 | Oct 18, 2002 | Start Trial | Start Trial |
Glaxosmithkline | CHILDREN'S ADVIL | ibuprofen | SUSPENSION;ORAL | 020589-001 | Jun 27, 1996 | Start Trial | Start Trial |
Mcneil Ped | MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020135-001 | Nov 16, 1994 | Start Trial | Start Trial |
J And J Consumer Inc | CHILDREN'S MOTRIN | ibuprofen | SUSPENSION;ORAL | 020516-001 | Jun 16, 1995 | Start Trial | Start Trial |
J And J Consumer Inc | CHILDREN'S MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020601-001 | Nov 15, 1996 | Start Trial | Start Trial |
Mcneil Ped | MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020135-001 | Nov 16, 1994 | Start Trial | Start Trial |
J And J Consumer Inc | JUNIOR STRENGTH MOTRIN | ibuprofen | TABLET, CHEWABLE;ORAL | 020601-003 | Nov 15, 1996 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IBUPROFEN
Country | Patent Number | Estimated Expiration |
---|---|---|
Canada | 2754922 | Start Trial |
South Africa | 200504239 | Start Trial |
Turkey | 200501948 | Start Trial |
Spain | 2694506 | Start Trial |
European Patent Office | 2453742 | Start Trial |
World Intellectual Property Organization (WIPO) | 2010105129 | Start Trial |
Canada | 2767971 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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