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 Actavis Labs Ut Inc, Mylan Technologies, Padagis Us, Rhodes Pharms, Riconpharma Llc, Zydus Pharms, and Baxter Hlthcare Corp, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-one drug master file entries for scopolamine. Ten suppliers are listed for this compound.
Summary for SCOPOLAMINE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 7 |
| Drug Master File Entries: | 21 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 41 |
| Clinical Trials: | 80 |
| Patent Applications: | 6,648 |
| Drug Prices: | Drug price trends for SCOPOLAMINE |
| What excipients (inactive ingredients) are in SCOPOLAMINE? | SCOPOLAMINE excipients list |
| DailyMed Link: | SCOPOLAMINE at DailyMed |
Recent Clinical Trials for SCOPOLAMINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen Scientific Affairs, LLC | Phase 1 |
| Yale University | Phase 1 |
| Dartmouth-Hitchcock Medical Center | Phase 1 |
Pharmacology for SCOPOLAMINE
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for SCOPOLAMINE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rhodes Pharms | SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 215329-001 | May 6, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 217893-001 | Aug 29, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Technologies | SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 203753-001 | Jun 19, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Padagis Us | SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 078830-001 | Jan 30, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Labs Ut Inc | SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 208769-001 | Jan 10, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Baxter Hlthcare Corp | TRANSDERM SCOP | scopolamine | SYSTEM;TRANSDERMAL | 017874-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Riconpharma Llc | SCOPOLAMINE | scopolamine | SYSTEM;TRANSDERMAL | 212342-001 | Nov 24, 2020 | AB | RX | 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 SCOPOLAMINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | TRANSDERM SCOP | scopolamine | SYSTEM;TRANSDERMAL | 017874-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare Corp | TRANSDERM SCOP | scopolamine | SYSTEM;TRANSDERMAL | 017874-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Baxter Hlthcare Corp | TRANSDERM SCOP | scopolamine | SYSTEM;TRANSDERMAL | 017874-001 | 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.
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