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SAVELLA Drug 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 four 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. Four suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
US ANDA Litigation and 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.
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: | 49 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 109 |
| Clinical Trials: | 21 |
| Patent Applications: | 318 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SAVELLA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SAVELLA |
| 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 |
| Spencer Dorn, MD, MPH | Phase 2 |
Pharmacology for SAVELLA
| Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Paragraph IV (Patent) Challenges for SAVELLA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SAVELLA | TABLET;ORAL | milnacipran hydrochloride | 022256 | 2013-01-14 |
US Patents and Regulatory Information for SAVELLA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-001 | Jan 14, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-001 | Jan 14, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-003 | Jan 14, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SAVELLA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 593199 | Start Trial |
| Japan | 2012193216 | Start Trial |
| New Zealand | 567271 | Start Trial |
| Japan | 2015134811 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
