SAVELLA Drug Patent Profile
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When do Savella patents expire, and what generic alternatives are available?
Savella is a drug marketed by Allergan and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has forty-nine patent family members in twenty-seven countries.
The generic ingredient in SAVELLA is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Savella
Savella was eligible for patent challenges on January 14, 2013.
There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for SAVELLA
International Patents: | 49 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 27 |
Patent Applications: | 391 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SAVELLA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SAVELLA |
What excipients (inactive ingredients) are in SAVELLA? | SAVELLA excipients list |
DailyMed Link: | SAVELLA at DailyMed |



Recent Clinical Trials for SAVELLA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Ottawa | Phase 4 |
Allergan | Phase 4 |
New York State Psychiatric Institute | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for SAVELLA
Paragraph IV (Patent) Challenges for SAVELLA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SAVELLA | Tablets | milnacipran hydrochloride | 12.5 mg, 25 mg, 50 mg, and 100 mg | 022256 | 8 | 2013-01-14 |
US Patents and Regulatory Information for SAVELLA
SAVELLA is protected by two US patents.
Patents protecting SAVELLA
Methods of treating fibromyalgia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF FIBROMYALGIA (FM)
Milnacipran for the long-term treatment of fibromyalgia syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF FIBROMYALGIA
Expired US Patents for SAVELLA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-001 | Jan 14, 2009 | See Plans and Pricing | See Plans and Pricing |
Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | See Plans and Pricing | See Plans and Pricing |
Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | See Plans and Pricing | See Plans and Pricing |
Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | See Plans and Pricing | See Plans and Pricing |
Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | See Plans and Pricing | See Plans and Pricing |
Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-003 | Jan 14, 2009 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SAVELLA
See the table below for patents covering SAVELLA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2395462 | See Plans and Pricing | |
Canada | 2493490 | See Plans and Pricing | |
Japan | 2012193216 | MILNACIPRAN FOR LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME | See Plans and Pricing |
Singapore | 10201807899P | MILNACIPRAN FOR THE LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME | See Plans and Pricing |
Costa Rica | 9882 | MILNACIPRAN PARA EL TRATAMIENTO A LARGO PLAZO DEL SINDROME DE FIBROMIALGIA | See Plans and Pricing |
Mexico | PA05000566 | TRATAMIENTO DE DEPRESION SECUNDARIA AL DOLOR (DSP). (TREATMENT OF DEPRESSION SECONDARY TO PAIN (DSP).) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |