Milnacipran hydrochloride - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for milnacipran hydrochloride and what is the scope of patent protection?
Milnacipran hydrochloride
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Uspharma Windlas, and Abbvie, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Milnacipran hydrochloride has thirty-three patent family members in twenty-three countries.
There are twenty-six drug master file entries for milnacipran hydrochloride. Three suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for milnacipran hydrochloride
International Patents: | 33 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 187 |
Clinical Trials: | 56 |
Patent Applications: | 654 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for milnacipran hydrochloride |
What excipients (inactive ingredients) are in milnacipran hydrochloride? | milnacipran hydrochloride excipients list |
DailyMed Link: | milnacipran hydrochloride at DailyMed |
Recent Clinical Trials for milnacipran hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mansoura University | N/A |
Yousra Hisham Abdel Fattah | N/A |
Allergan | Phase 4 |
Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 100MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 50MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 25MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for milnacipran hydrochloride
Drug Class | Serotonin and Norepinephrine Reuptake Inhibitor |
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for milnacipran hydrochloride
Paragraph IV (Patent) Challenges for MILNACIPRAN HYDROCHLORIDE
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 milnacipran hydrochloride
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 | 022256-003 | Jan 14, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Uspharma Windlas | MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205071-004 | Jan 27, 2016 | DISCN | No | No | ⤷ 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 milnacipran hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-002 | 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 | 022256-001 | Jan 14, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for milnacipran hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 228904 | שימוש במילנקיפרן, או מלח מתאים פרמצבטי, בהכנת תרופה לטיפול בפיברומילג'יה (Use of milnacipran or a pharmaceutically acceptable salt thereof in the preparation of a medicament for treating fibromyalgia) | ⤷ Sign Up |
Japan | 2012193216 | MILNACIPRAN FOR LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME | ⤷ Sign Up |
Tunisia | SN08129 | MILNACIPRAN FOR THE LONG-TERM TREATMENT OF FIBROMYALGIA SYNDROME | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.