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Generated: September 23, 2017

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Ropivacaine hydrochloride - Generic Drug Details

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

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 four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ropivacaine hydrochloride has sixty-five 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:4
Applicants:6
NDAs:6
Drug Master File Entries: see list13
Suppliers / Packagers: see list8
Bulk Api Vendors: see list93
Clinical Trials: see list2,642
Patent Applications: see list4,873
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 1996APRXYesNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 1996APRXYesNo► Subscribe► Subscribe► Subscribe
Navinta Llc
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
SOLUTION;INJECTION078601-003Jul 17, 2014APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-007Sep 24, 1996RXYesNo► Subscribe► SubscribeY ► Subscribe
Hospira
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
SOLUTION;INJECTION090194-006Sep 23, 2014APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-006Sep 24, 1996APRXYesNo► Subscribe► SubscribeY ► Subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-002Sep 24, 1996APRXYesNo► Subscribe► Subscribe► Subscribe
Hospira
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
SOLUTION;INJECTION090194-003Sep 23, 2014APRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
SOLUTION;INJECTION205612-006Jul 13, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
ROPIVACAINE HYDROCHLORIDE
ropivacaine hydrochloride
SOLUTION;INJECTION205612-004Jul 13, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ropivacaine hydrochloride

International Patent Family for Ingredient: ropivacaine hydrochloride

Country Document Number Estimated Expiration
Hong Kong1081430► Subscribe
China100408013► Subscribe
Germany502004008025► Subscribe
Australia2004224795► Subscribe
Spain2343456► Subscribe
Denmark1605891► Subscribe
Australia2003208752► Subscribe
Poland212919► Subscribe
Canada2542408► Subscribe
Spain2309491► 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
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
C0042Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE ROPIVACAINE MONOHYDRATE; NAT. REGISTRATION NO/DATE: 212 IS 216 F 12 19960806; FIRST REGISTRATION: SE 12319 19950915
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Chubb
Healthtrust
Harvard Business School
Merck
AstraZeneca
US Army
Teva
Baxter
Moodys

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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