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Generated: October 20, 2017
What is the patent landscape for Razadyne Er, and when can generic versions of Razadyne Er launch?
Razadyne Er is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 44 |
| Clinical Trials: see list | 8 |
| Patent Applications: see list | 361 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | RAZADYNE ER at DailyMed |
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-001 | Apr 1, 2005 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||
Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-002 | Apr 1, 2005 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||
Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-003 | Apr 1, 2005 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-001 | Apr 1, 2005 | ► Subscribe | ► Subscribe | ||||||||
Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-003 | Apr 1, 2005 | ► Subscribe | ► Subscribe | ||||||||
Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-002 | Apr 1, 2005 | ► Subscribe | ► Subscribe | ||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| galantamine hydrobromide | Extended-release Capsules | 16 mg and 24 mg | Razadyne ER | 3/11/2006 |
| galantamine hydrobromide | Extended-release Capsules | 8 mg | Razadyne ER | 3/2/2006 |
| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 0038686 | ► Subscribe | |||||||||||||
| Austria | 252386 | ► Subscribe | |||||||||||||
| Japan | 2002533396 | ► Subscribe | |||||||||||||
| Bulgaria | 105564 | ► Subscribe | |||||||||||||
| South Africa | 200105132 | ► Subscribe | |||||||||||||
| Portugal | 1140105 | ► Subscribe | |||||||||||||
| New Zealand | 511643 | ► Subscribe | |||||||||||||
| South Korea | 100437105 | ► Subscribe | |||||||||||||
| Hong Kong | 1043062 | ► Subscribe | |||||||||||||
| China | 100370990 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00140 | Netherlands | ► Subscribe | PRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225 | ||||||||||||
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Serving leading biopharmaceutical companies globally:
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 verifification 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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