IBUPROFEN SODIUM - Generic Drug Details
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What are the generic sources for ibuprofen sodium and what is the scope of freedom to operate?
Ibuprofen sodium
is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and Perrigo R And D, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for ibuprofen sodium. One supplier is listed for this compound.
Summary for IBUPROFEN SODIUM
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 45 |
Clinical Trials: | 39 |
Patent Applications: | 7,196 |
What excipients (inactive ingredients) are in IBUPROFEN SODIUM? | IBUPROFEN SODIUM excipients list |
DailyMed Link: | IBUPROFEN SODIUM at DailyMed |
Recent Clinical Trials for IBUPROFEN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
CMC Ambroise Paré | N/A |
Universitat Internacional de Catalunya | Phase 4 |
Ajman University | Phase 4 |
Pharmacology for IBUPROFEN SODIUM
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for IBUPROFEN SODIUM
US Patents and Regulatory Information for IBUPROFEN SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Haleon Us Holdings | ADVIL | ibuprofen sodium | TABLET;ORAL | 201803-001 | Jun 12, 2012 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Perrigo R And D | IBUPROFEN SODIUM | ibuprofen sodium | TABLET;ORAL | 206581-001 | Aug 3, 2015 | 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 |
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