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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Accenture
Novartis
Merck
Baxter
Boehringer Ingelheim
Dow
Medtronic
McKesson

Generated: January 19, 2018

DrugPatentWatch Database Preview

Levomilnacipran hydrochloride - Generic Drug Details

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What are the generic drug sources for levomilnacipran hydrochloride and what is the scope of levomilnacipran hydrochloride freedom to operate?

Levomilnacipran hydrochloride
is the generic ingredient in one branded drug marketed by Forest Labs Inc and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Levomilnacipran hydrochloride has fifty-four patent family members in twenty-seven countries.

There are nine drug master file entries for levomilnacipran hydrochloride. Two suppliers are listed for this compound.
Summary for levomilnacipran hydrochloride
Pharmacology for levomilnacipran hydrochloride

US Patents and Regulatory Information for levomilnacipran hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-004 Jul 25, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-001 Jul 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-004 Jul 25, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-002 Jul 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-003 Jul 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-003 Jul 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Inc FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168-003 Jul 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for levomilnacipran hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,259,403 Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide ➤ Subscribe
7,005,452 Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug ➤ Subscribe
7,074,833 Use of the (1S,2R) enantiomer of milnacipran for the preparation of a drug ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for levomilnacipran hydrochloride

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Serving leading biopharmaceutical companies globally:

Queensland Health
Julphar
Fuji
Cerilliant
UBS
Novartis
Cipla
Farmers Insurance
Colorcon

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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