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Serving 500+ biopharmaceutical companies globally:
Generated: July 24, 2017
What is the competitive landscape for ACORDA, and what generic alternatives to ACORDA drugs are available?
ACORDA has four approved drugs.| Patents: | 6 |
| Tradenames: | 3 |
| Ingredients: | 3 |
| NDAs: | 4 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Acorda | ZANAFLEX | tizanidine hydrochloride | CAPSULE;ORAL | 021447-001 | Aug 29, 2002 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Acorda | ZANAFLEX | tizanidine hydrochloride | CAPSULE;ORAL | 021447-003 | Aug 29, 2002 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
dalfampridine | Extended-release Tablets | 10 mg | AMPYRA | 1/22/2014 |
tizanidine hydrochloride | Capsules | 2 mg, 4 mg and 6 mg | ZANAFLEX | 8/10/2007 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,370,879 | Formulations and their use in the treatment of neurological diseases | ► Subscribe | |||||||||||||||||||||||||||
| 6,248,788 | Therapeutic method with capsaicin and capasicin analogs | ► Subscribe | |||||||||||||||||||||||||||
| 5,580,580 | Formulations and their use in the treatment of neurological diseases | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 2460521 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2460521 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 240439 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2377536 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2367707 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0612 | Netherlands | ► Subscribe | PRODUCT NAME: 4-AMINOPYRIDINE, DAN WEL EEN DERIVAAT DAARVAN, IN HET BIJZONDER EEN ZOUT, SOLVAAT OF PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720 | ||||||||||||||||||||||||||
| C/GB11/055 | United Kingdom | ► Subscribe | PRODUCT NAME: 4-AMINOPYRIDINE OR A SALT THEREOF; REGISTERED: UK EU/1/11/699/001 20110720; UK EU/1/11/699/002 20110720 | ||||||||||||||||||||||||||
| 2012001 | Lithuania | ► Subscribe | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720 | ||||||||||||||||||||||||||
| 90033-9 | Sweden | ► Subscribe | PRODUCT NAME: 4-AMINOPYRIDIN ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/11/699/001 20110720 | ||||||||||||||||||||||||||
| 2013000046 | Germany | ► Subscribe | PRODUCT NAME: 4-AMINOPYRIDIN ODER EIN DERIVAT DAVON, INSBESONDERE EIN SALZ, EIN SOLVAT ODER EINE PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720 | ||||||||||||||||||||||||||
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Serving 500+ 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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