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Milnacipran hydrochloride - Generic Drug Details

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Milnacipran hydrochloride is the generic ingredient in two branded drugs marketed by Cypress Bioscience, Liberty Pharma Inc, and Amneal Pharms, and is included in three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-one patent family members in twenty-five countries.

There are nineteen drug master file entries for milnacipran hydrochloride. Eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: milnacipran hydrochloride

Tradenames:2
Patents:4
Applicants:3
NDAs:3
Drug Master File Entries: see list19
Suppliers / Packaging: see list8

Pharmacology for Ingredient: milnacipran hydrochloride

Tentative approvals for MILNACIPRAN HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL12.5MG
<disabled><disabled>TABLET;ORAL25MG
<disabled><disabled>TABLET;ORAL50MG

Clinical Trials for: milnacipran hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
MILNACIPRAN HYDROCHLORIDE
milnacipran hydrochloride
TABLET;ORAL205081-004Apr 22, 2016RXNo<disabled><disabled>
Cypress Bioscience
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-004Jan 14, 2009RXNo6,992,110<disabled> <disabled>
Cypress Bioscience
SAVELLA
milnacipran hydrochloride
TABLET;ORAL022256-002Jan 14, 2009RXNo6,992,110<disabled> <disabled>
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Non-Orange Book Patents for Generic Ingredient: milnacipran 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
7,915,246Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain<disabled in preview>
6,635,675 Method of treating chronic fatigue syndrome<disabled in preview>
7,820,643Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: milnacipran hydrochloride

Country Document Number Estimated Expiration
Ukraine94721<disabled in preview>
Norway20081951<disabled in preview>
Costa Rica9882<disabled in preview>
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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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