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Ropivacaine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ropivacaine hydrochloride?

Ropivacaine hydrochloride is the generic ingredient in two branded drugs marketed by Navinta Llc, Aurobindo Pharma Ltd, Sagent Strides, Fresenius Kabi Usa, Akorn Inc, and Hospira, and is included in six NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ropivacaine hydrochloride has sixty-four patent family members in twenty countries.

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

Summary for Generic Name: ropivacaine hydrochloride

Tradenames:2
Patents:5
Applicants:6
NDAs:6
Drug Master File Entries: see list13
Suppliers / Packagers: see list8
Bulk Api Vendors: see list93
Clinical Trials: see list1,149
Patent Applications: see list4,691
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ropivacaine hydrochloride at DailyMed

Pharmacology for Ingredient: ropivacaine hydrochloride

Ingredient-typeAmides
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-010Jan 4, 2011RXYesNo► Subscribe► Subscribe
Akorn Inc
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
INJECTABLE;INJECTION203955-001Apr 11, 2016RXNoNo► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-003May 1, 1998RXYesNo► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-011Sep 24, 1996RXYesYes► Subscribe► Subscribe
Sagent Strides
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
SOLUTION;INJECTION090318-002Sep 23, 2014RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ropivacaine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 19965,834,489► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 19965,834,489► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-001May 1, 19984,695,576► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 19964,870,086► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 19964,695,576► Subscribe
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International Patent Family for Ingredient: ropivacaine hydrochloride

Country Document Number Estimated Expiration
Slovenia1507502► Subscribe
Germany10223560► Subscribe
Australia2003208752► Subscribe
Slovenia1605891► Subscribe
Spain2343456► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ROPIVACAINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0042Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915
C/GB96/051United Kingdom► SubscribePRODUCT 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
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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 verifification 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.

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