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® Litigation and Generic Entry Outlook for Savella
A generic version of SAVELLA was approved as milnacipran hydrochloride by HETERO LABS LTD V on October 3rd, 2024.
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Questions you can ask:
- What is the 5 year forecast for SAVELLA?
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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: | 405 |
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 |
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 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-003 | Jan 14, 2009 | AB | 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 | 022256-002 | Jan 14, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | Jan 14, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-003 | Jan 14, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-003 | 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 |
---|---|---|---|
Russian Federation | 2437661 | МИЛНАЦИПРАН В КАЧЕСТВЕ СРЕДСТВА ДЛЯ ПРОДОЛЖИТЕЛЬНОГО ЛЕЧЕНИЯ СИНДРОМА ФИБРОМИАЛГИИ (MILNACIPRAN AS MEDICATION FOR CONTINUOUS TREATMENT OF FIBROMYALGIA SYNDROME) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2004009069 | ⤷ Sign Up | |
European Patent Office | 2682114 | Milnacipran pour le traitement a long terme du syndrome de la fibromyalgie (Milnacipran for the long-term treatment of fibromyalgia syndrome) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2007038620 | ⤷ Sign Up | |
Japan | 6014702 | ⤷ Sign Up | |
Nicaragua | 200800099 | MILNACIPAN PARA EL TRATAMIENTO A LARGO PLAZO DEL SÍNDROME DE FIBROMALGIA | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |