SAVELLA Drug Patent Profile
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Which patents cover Savella, and when can generic versions of Savella launch?
Savella is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has thirty-three patent family members in twenty-three 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 four 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.
There are five tentative approvals for the generic drug (milnacipran hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for SAVELLA
International Patents: | 33 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Clinical Trials: | 27 |
Patent Applications: | 367 |
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 |
Research Foundation for Mental Hygiene, Inc. | N/A |
Pharmacology for SAVELLA
Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
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 one US patents.
Patents protecting SAVELLA
Milnacipran for the long-term treatment of fibromyalgia syndrome
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF FIBROMYALGIA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-001 | Jan 14, 2009 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-003 | Jan 14, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SAVELLA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-001 | Jan 14, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-001 | Jan 14, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
China | 1671368 | ⤷ Sign Up | |
European Patent Office | 1928446 | MILNACIPRAN POUR LE TRAITEMENT A LONG TERME DU SYNDROME DE LA FIBROMYALGIE (MILNACIPRAN FOR THE LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME) | ⤷ Sign Up |
Japan | 2015134811 | 線維筋痛症候群の長期治療のためのミルナシプラン (MILNACIPRAN FOR LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME) | ⤷ Sign Up |
Nicaragua | 200800099 | MILNACIPAN PARA EL TRATAMIENTO A LARGO PLAZO DEL SÍNDROME DE FIBROMALGIA | ⤷ Sign Up |
Russian Federation | 2008112192 | МИЛНАЦИПРАН В КАЧЕСТВЕ СРЕДСТВА ДЛЯ ПРОДОЛЖИТЕЛЬНОГО ЛЕЧЕНИЯ СИНДРОМА ФИБРОМИАЛГИИ | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |