Ropivacaine hydrochloride - Generic Drug Details

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What are the generic 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, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Inforlife, Navinta Llc, Rising, and Somerset Theraps Llc, and is included in twelve 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 ten drug master file entries for ropivacaine hydrochloride. Thirteen suppliers are listed for this compound.

Summary for ropivacaine hydrochloride

International Patents:	76
US Patents:	4
Tradenames:	2
Applicants:	11
NDAs:	12
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	185
Clinical Trials:	816
Patent Applications:	6,982
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
Assiut University	Phase 4
Peking University First Hospital	Phase 2
Beijing Friendship Hospital	N/A

See all ropivacaine hydrochloride clinical trials

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
Navinta Llc	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	078601-002	Jul 17, 2014	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	090194-003	Sep 23, 2014	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Somerset Theraps Llc	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	SOLUTION;INJECTION	207636-004	Jun 15, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-002	Sep 24, 1996	AP	RX	Yes	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 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	020533-004	Sep 24, 1996	⤷ Sign Up	⤷ Sign Up
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	⤷ Sign Up	⤷ Sign Up
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-001	May 1, 1998	⤷ Sign Up	⤷ Sign Up
Fresenius Kabi Usa	NAROPIN	ropivacaine hydrochloride	SOLUTION;INJECTION	020533-005	Sep 24, 1996	⤷ Sign Up	⤷ Sign Up
>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
European Patent Office	2301622	Connecteur pour des emballages contenant des fluides médicaux et emballage pour fluides médicaux (Connector for packaging containing medical fluids and packaging for medical fluids)	⤷ Sign Up
China	1867375	Connector for medical liquid-containing packages and medical liquid-containing packages	⤷ Sign Up
Norway	339635		⤷ Sign Up
Japan	4533887		⤷ Sign Up
>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	⤷ Sign Up	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	⤷ Sign Up	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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