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Scopolamine - Generic Drug Details
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What are the generic sources for scopolamine and what is the scope of freedom to operate?
Scopolamine
is the generic ingredient in two branded drugs marketed by Mylan Technologies, Perrigo Pharms Co, and Glaxosmithkline Con, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-one drug master file entries for scopolamine. Five suppliers are listed for this compound.
Summary for scopolamine
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 21 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 33 |
| Clinical Trials: | 67 |
| Patent Applications: | 4,196 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for scopolamine |
| DailyMed Link: | scopolamine at DailyMed |
Recent Clinical Trials for scopolamine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| EMS | Phase 2 |
| Peking University Hospital of Stomatology | N/A |
| Peking University First Hospital | N/A |
Pharmacology for scopolamine
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
US Patents and Regulatory Information for scopolamine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline Con | TRANSDERM SCOP | scopolamine | FILM, EXTENDED RELEASE;TRANSDERMAL | 017874-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Perrigo Pharms Co | SCOPOLAMINE | scopolamine | FILM, EXTENDED RELEASE;TRANSDERMAL | 078830-001 | Jan 30, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Technologies | SCOPOLAMINE | scopolamine | FILM, EXTENDED RELEASE;TRANSDERMAL | 203753-001 | Jun 19, 2019 | AB | RX | No | 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 |
Expired US Patents for scopolamine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Con | TRANSDERM SCOP | scopolamine | FILM, EXTENDED RELEASE;TRANSDERMAL | 017874-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Glaxosmithkline Con | TRANSDERM SCOP | scopolamine | FILM, EXTENDED RELEASE;TRANSDERMAL | 017874-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Glaxosmithkline Con | TRANSDERM SCOP | scopolamine | FILM, EXTENDED RELEASE;TRANSDERMAL | 017874-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| >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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