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Ropivacaine hydrochloride - Generic Drug Details

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What are the generic drug sources for ropivacaine hydrochloride and what is the scope of patent protection?

Ropivacaine hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Akorn, Aurobindo Pharma Ltd, Caplin, Hikma Pharms, Hospira, Inforlife, Mylan Asi, Navinta Llc, and Somerset Theraps Llc, and is included in eleven NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ropivacaine hydrochloride has seventy-six patent family members in twenty countries.

There are thirteen drug master file entries for ropivacaine hydrochloride. Eleven suppliers are listed for this compound.

Summary for ropivacaine hydrochloride

International Patents:	76
US Patents:	4
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	159
Clinical Trials:	728
Patent Applications:	6,828
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ropivacaine hydrochloride
What excipients (inactive ingredients) are in ropivacaine hydrochloride?	ropivacaine hydrochloride excipients list
DailyMed Link:	ropivacaine hydrochloride at DailyMed

Recent Clinical Trials for ropivacaine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mayo Clinic	Phase 3
Pontificia Universidade Catolica de Sao Paulo	Phase 4
Suez Canal University	N/A

See all ropivacaine hydrochloride clinical trials

Pharmacology for ropivacaine hydrochloride

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Paragraph IV (Patent) Challenges for ROPIVACAINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
NAROPIN	SOLUTION;INJECTION	ropivacaine hydrochloride	020533	2015-09-03
NAROPIN	SOLUTION;INJECTION	ropivacaine hydrochloride	020533	2015-01-30
NAROPIN	SOLUTION;INJECTION	ropivacaine hydrochloride	020533	2006-11-13

US Patents and Regulatory Information for ropivacaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Somerset Theraps Llc	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	207636-005	Jun 15, 2018	AP	RX	No	No
Somerset Theraps Llc	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	207636-001	Jun 15, 2018	AP	RX	No	No
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996	AP	RX	Yes	No

Expired US Patents for ropivacaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996

International Patents for ropivacaine hydrochloride

Country	Patent Number	Estimated Expiration
Norway	20062091
Japan	2007508081
Austria	407653

Supplementary Protection Certificates for ropivacaine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0239710	96C0042	Belgium		PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915
0239710	SPC/GB96/051	United Kingdom		PRODUCT NAME: (S)-(-)-1-PROPYL-2',6'-PIPECOLOXYLIDIDE HYDROCHLORIDE MONOHYDRATE (GENERIC NAME: ROPIVACAINE MONOHYDROCHLORIDE MONOHYDRATE); REGISTERED: SE 12319 19950915; SE 12322 19950915; SE 12323 19950915; UK 0017/0375 19960517; UK 0017/0376 19960517; UK 0017/0377 19960517; UK 0017/0378 19960517