MOLINDONE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for molindone hydrochloride and what is the scope of freedom to operate?
Molindone hydrochloride
is the generic ingredient in two branded drugs marketed by Chartwell Rx, Endo Pharms, and Epic Pharma Llc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for molindone hydrochloride. One supplier is listed for this compound.
Summary for MOLINDONE HYDROCHLORIDE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 4 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 75 |
| Clinical Trials: | 2 |
| Patent Applications: | 3,298 |
| What excipients (inactive ingredients) are in MOLINDONE HYDROCHLORIDE? | MOLINDONE HYDROCHLORIDE excipients list |
| DailyMed Link: | MOLINDONE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for MOLINDONE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Supernus Pharmaceuticals, Inc. | Phase 2 |
| National Institute of Mental Health (NIMH) | Phase 4 |
| University of North Carolina, Chapel Hill | Phase 4 |
Pharmacology for MOLINDONE HYDROCHLORIDE
| Drug Class | Typical Antipsychotic |
Medical Subject Heading (MeSH) Categories for MOLINDONE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for MOLINDONE HYDROCHLORIDE
US Patents and Regulatory Information for MOLINDONE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Epic Pharma Llc | MOLINDONE HYDROCHLORIDE | molindone hydrochloride | TABLET;ORAL | 090453-001 | Mar 20, 2015 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | MOBAN | molindone hydrochloride | TABLET;ORAL | 017111-008 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | MOBAN | molindone hydrochloride | TABLET;ORAL | 017111-005 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | MOBAN | molindone hydrochloride | TABLET;ORAL | 017111-007 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | MOBAN | molindone hydrochloride | CAPSULE;ORAL | 017111-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | MOBAN | molindone hydrochloride | CAPSULE;ORAL | 017111-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 MOLINDONE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Endo Pharms | MOBAN | molindone hydrochloride | CONCENTRATE;ORAL | 017938-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Chartwell Rx | MOBAN | molindone hydrochloride | TABLET;ORAL | 017111-005 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Chartwell Rx | MOBAN | molindone hydrochloride | TABLET;ORAL | 017111-006 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Chartwell Rx | MOBAN | molindone hydrochloride | TABLET;ORAL | 017111-008 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Chartwell Rx | MOBAN | molindone hydrochloride | TABLET;ORAL | 017111-007 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Chartwell Rx | MOBAN | molindone hydrochloride | TABLET;ORAL | 017111-004 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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.
ISSN: 2162-2639
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