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:	351
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
Simbec Research	Phase 1
Reckitt Benckiser Healthcare (UK) Limited	Phase 1

See all IBUPROFEN LYSINE clinical trials

Pharmacology for IBUPROFEN LYSINE

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for IBUPROFEN LYSINE

B05XB	Amino acids
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Xgen Pharms	IBUPROFEN LYSINE	ibuprofen lysine	INJECTABLE;INTRAVENOUS	202402-001	Mar 30, 2016	AP	RX	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

Expired US Patents for IBUPROFEN LYSINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	⤷ Sign Up	⤷ Sign Up
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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