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Milnacipran hydrochloride - Generic Drug Details
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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 Allergan, and is included in three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Milnacipran hydrochloride has forty-nine patent family members in twenty-seven countries.
There are twenty-eight drug master file entries for milnacipran hydrochloride. Five suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for milnacipran hydrochloride
| International Patents: | 49 |
| US Patents: | 4 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 28 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 131 |
| Clinical Trials: | 54 |
| Patent Applications: | 512 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for milnacipran hydrochloride |
| DailyMed Link: | milnacipran hydrochloride at DailyMed |
Recent Clinical Trials for milnacipran hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yousra Hisham Abdel Fattah | N/A |
| Allergan | Phase 4 |
| University of Ottawa | Phase 4 |
Generic filers with tentative approvals for MILNACIPRAN HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 25MG | TABLET;ORAL |
| Start Trial | Start Trial | 12.5MG | TABLET;ORAL |
| Start Trial | Start Trial | 100MG | 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 |
Paragraph IV (Patent) Challenges for MILNACIPRAN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SAVELLA | TABLET;ORAL | milnacipran hydrochloride | 022256 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-003 | Jan 14, 2009 | RX | Yes | Yes | 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 | ||||
| Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | Jan 14, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Amneal Pharms | MILNACIPRAN HYDROCHLORIDE | milnacipran hydrochloride | TABLET;ORAL | 205081-002 | Apr 22, 2016 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Allergan | SAVELLA | milnacipran hydrochloride | TABLET;ORAL | 022256-004 | 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 | 022256-004 | Jan 14, 2009 | RX | Yes | No | 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 milnacipran hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Nicaragua | 200800099 | Start Trial |
| Portugal | 2322225 | Start Trial |
| Tunisia | SN08129 | Start Trial |
| Australia | 2003268020 | Start Trial |
| Japan | 2012193216 | Start Trial |
| New Zealand | 567271 | Start Trial |
| New Zealand | 593199 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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.
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