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, Amneal, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Inforlife, Kindos, Mylan Labs Ltd, Navinta Llc, Rising, and Somerset Theraps Llc, and is included in sixteen NDAs. There are three 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 ten drug master file entries for ropivacaine hydrochloride. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ropivacaine hydrochloride

International Patents:	76
US Patents:	3
Tradenames:	2
Applicants:	13
NDAs:	16
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	189
Clinical Trials:	865
Patent Applications:	370
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
McMaster University	Phase 4
Ziekenhuis Oost-Limburg	N/A
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2

See all ropivacaine hydrochloride clinical trials

Generic filers with tentative approvals for ROPIVACAINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Subscribe	⤷ Subscribe	100MG/20ML (5MG/ML)	SOLUTION;INJECTION
⤷ Subscribe	⤷ Subscribe	40MG/20ML (2MG/ML)	SOLUTION;INJECTION
⤷ Subscribe	⤷ Subscribe	400MG/200ML (2MG/ML)	SOLUTION;INJECTION

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 ropivacaine hydrochloride

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for ropivacaine hydrochloride

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

Paragraph IV (Patent) Challenges for ROPIVACAINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAROPIN	Injection	ropivacaine hydrochloride	2 mg/mL, 200 mL	020533	1	2015-09-03
NAROPIN	Injection	ropivacaine hydrochloride	2 mg/mL, 100 mL	020533	1	2015-01-30
NAROPIN	Injection	ropivacaine hydrochloride	2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials	020533	1	2006-11-13

US Patents and Regulatory Information for ropivacaine hydrochloride

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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
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996	AP	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-008	Sep 24, 1996	AP	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	AP	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Inforlife	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	206166-003	Jun 11, 2018	AP	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998	AP	RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Hikma	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	214074-001	Jul 20, 2020	AP	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-006	Sep 24, 1996	AP	RX	Yes	No	7,857,802	⤷ Subscribe	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 ropivacaine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-006	Sep 24, 1996	8,118,802	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996	5,670,524	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-003	May 1, 1998	4,695,576	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-004	Sep 24, 1996	4,695,576	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	4,870,086	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	4,695,576	⤷ Subscribe
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-007	Sep 24, 1996	8,118,802	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ropivacaine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Canada	2487551	RACCORD POUR EMBALLAGES CONTENANT DES LIQUIDES MEDICINAUX ETEMBALLAGE POUR LIQUIDES MEDICINAUX (CONNECTOR FOR PACKAGING CONTAINING MEDICAL FLUIDS AND PACKAGING FOR MEDICAL FLUIDS)	⤷ Subscribe
Brazil	PI0311342	conector para embalagens que contêm líquidos medicinais	⤷ Subscribe
Hong Kong	1089080	CONNECTOR FOR MEDICAL LIQUID-CONTAINING PACKAGES AND MEDICAL LIQUID- CONTAINING PACKAGES	⤷ Subscribe
Brazil	PI0415438	conector para pacotes contendo lìquido médico e pacote para lìquidos médicos	⤷ Subscribe
China	100398084		⤷ Subscribe
Brazil	0311342	Conector para embalagens que contêm lìquidos medicinais e embalagem para lìquidos medicinais	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2005037362		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ropivacaine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0239710	SPC/GB96/051	United Kingdom	⤷ Subscribe	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
0239710	96C0042	Belgium	⤷ Subscribe	PRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.