IBUPROFEN LYSINE - Generic Drug Details
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What are the generic drug sources for ibuprofen lysine and what is the scope of freedom to operate?
Ibuprofen lysine
is the generic ingredient in two branded drugs marketed by Xgen Pharms and Recordati Rare, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for ibuprofen lysine. Three suppliers are listed for this compound.
Summary for IBUPROFEN LYSINE
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 59 |
Clinical Trials: | 5 |
Patent Applications: | 381 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IBUPROFEN LYSINE |
What excipients (inactive ingredients) are in IBUPROFEN LYSINE? | IBUPROFEN LYSINE excipients list |
DailyMed Link: | IBUPROFEN LYSINE at DailyMed |
Recent Clinical Trials for IBUPROFEN LYSINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Oxford Pharmascience Ltd | Phase 1 |
Reckitt Benckiser Healthcare (UK) Limited | Phase 1 |
Simbec Research | Phase 1 |
Pharmacology for IBUPROFEN LYSINE
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for IBUPROFEN LYSINE
Paragraph IV (Patent) Challenges for IBUPROFEN LYSINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NEOPROFEN | Injection | ibuprofen lysine | 10 mg/mL, 2 mL vials | 021903 | 1 | 2010-10-01 |
US Patents and Regulatory Information for IBUPROFEN LYSINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Xgen Pharms | IBUPROFEN LYSINE | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 202402-001 | Mar 30, 2016 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903-001 | Apr 13, 2006 | AP | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | |
>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 LYSINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903-001 | Apr 13, 2006 | ⤷ Subscribe | ⤷ Subscribe |
Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903-001 | Apr 13, 2006 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
IBUPROFEN LYSINE Market Analysis and Financial Projection Experimental
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