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RELPAX Drug Profile

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Relpax is a drug marketed by Pfizer Ireland and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-seven patent family members in forty-six countries.

The generic ingredient in RELPAX is eletriptan hydrobromide. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the eletriptan hydrobromide profile page.

Summary for Tradename: RELPAX

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list5
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Ireland
RELPAX
eletriptan hydrobromide
TABLET;ORAL021016-001Dec 26, 2002RXNo5,545,644► subscribeYY ► subscribe
Pfizer Ireland
RELPAX
eletriptan hydrobromide
TABLET;ORAL021016-002Dec 26, 2002RXYes6,110,940► subscribe ► subscribe
Pfizer Ireland
RELPAX
eletriptan hydrobromide
TABLET;ORAL021016-001Dec 26, 2002RXNo6,110,940► subscribe ► subscribe
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Paragraph IV activity for: RELPAX

Drugname Dosage Strength RLD Submissiondate
eletriptan hydrobromideTablets20 mg and 40 mgRelpax3/29/2010

Non-Orange Book Patents for Tradename: RELPAX

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
5,559,129 Indole derivatives► subscribe
6,380,226 Salts of an anti-migraine indole derivatives► subscribe
5,607,951 Indole derivatives► 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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International Patent Family for Tradename: RELPAX

Country Document Number Estimated Expiration
Brazil9406435► subscribe
Canada2198599► subscribe
Yugoslavia49287► 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 Certificates for Tradename: RELPAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2001Austria► subscribePRODUCT NAME: ELETRIPTAN UND DIE PHARMAZEUTISCH VERTRAEGLICHEN SALZE DAVON, EINSCHLIESSLICH DES HYDROBROMIDS; NAT. REGISTRATION NO/DATE: 1-24155 20010801; FIRST REGISTRATION: LI 55218 01, 55218 02 20001214
C0013France► subscribePRODUCT NAME: ELETRIPTAN HYDROBROMIDE; NAT. REGISTRATION NO/DATE: NL 26625 20011105; FIRST REGISTRATION: LI - IKS 55218 20001214
C/GB01/023United Kingdom► subscribePRODUCT NAME: ELETRIPTAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE HYDROBROMIDE SALT; REGISTERED: CH 55218 01 20001214; CH 52218 02 20001214; CH 52218 03 20001214; UK PL 00057/0452 20010212; UK PL 00057/0453 20010212; UK PL 00057/0454 20010212
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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 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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