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Generated: December 18, 2017

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Eletriptan hydrobromide - Generic Drug Details

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What are the generic drug sources for eletriptan hydrobromide and what is the scope of eletriptan hydrobromide freedom to operate?

Eletriptan hydrobromide
is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Mylan Pharms Inc, Teva Pharms Usa, Zydus Pharms Usa Inc, and Pfizer Ireland, and is included in five NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Eletriptan hydrobromide has one hundred and fifty patent family members in forty-six countries and four supplementary protection certificates in four countries.

There are twelve drug master file entries for eletriptan hydrobromide. Eleven suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for eletriptan hydrobromide

Tentative approvals for ELETRIPTAN HYDROBROMIDE

Applicant Application No. Strength Dosage Form
u► Subscribe20MGTABLET; ORAL
u► Subscribe40MGTABLET; ORAL
u► SubscribeEQ 40MG BASETABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer IrelandRELPAXeletriptan hydrobromideTABLET;ORAL021016-001Dec 26, 2002ABRXYesNo► Subscribe► SubscribeYY► Subscribe
Mylan Pharms IncELETRIPTAN HYDROBROMIDEeletriptan hydrobromideTABLET;ORAL205152-001Aug 11, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncELETRIPTAN HYDROBROMIDEeletriptan hydrobromideTABLET;ORAL205152-002Aug 11, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Pfizer IrelandRELPAXeletriptan hydrobromideTABLET;ORAL021016-002Dec 26, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Pfizer IrelandRELPAXeletriptan hydrobromideTABLET;ORAL021016-002Dec 26, 2002ABRXYesYes► Subscribe► SubscribeYY► Subscribe
Pfizer IrelandRELPAXeletriptan hydrobromideTABLET;ORAL021016-001Dec 26, 2002ABRXYesNo► Subscribe► Subscribe► Subscribe
Teva Pharms UsaELETRIPTAN HYDROBROMIDEeletriptan hydrobromideTABLET;ORAL202040-002Jun 27, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Ajanta Pharma LtdELETRIPTAN HYDROBROMIDEeletriptan hydrobromideTABLET;ORAL205186-002Aug 29, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncELETRIPTAN HYDROBROMIDEeletriptan hydrobromideTABLET;ORAL206409-001Jun 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms UsaELETRIPTAN HYDROBROMIDEeletriptan hydrobromideTABLET;ORAL202040-001Jun 27, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: eletriptan hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer IrelandRELPAXeletriptan hydrobromideTABLET;ORAL021016-002Dec 26, 2002► Subscribe► Subscribe
Pfizer IrelandRELPAXeletriptan hydrobromideTABLET;ORAL021016-001Dec 26, 2002► Subscribe► Subscribe
Pfizer IrelandRELPAXeletriptan hydrobromideTABLET;ORAL021016-002Dec 26, 2002► Subscribe► Subscribe
Pfizer IrelandRELPAXeletriptan hydrobromideTABLET;ORAL021016-001Dec 26, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: eletriptan hydrobromide

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
5,607,951 Indole derivatives► Subscribe
6,380,226 Salts of an anti-migraine indole derivatives► Subscribe
5,578,612 Indole derivatives► Subscribe
5,559,246 Indole derivatives► Subscribe
5,559,129 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 Ingredient: eletriptan hydrobromide

Country Document Number Estimated Expiration
Greece3026475► Subscribe
Hungary9503089► Subscribe
Spain2112650► Subscribe
Portugal99218► Subscribe
Iceland1850► Subscribe
Australia8950491► Subscribe
World Intellectual Property Organization (WIPO)9206973► Subscribe
Japan2904588► Subscribe
JapanH08504829► Subscribe
Yugoslavia165391► 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: ELETRIPTAN HYDROBROMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0013France► SubscribePRODUCT NAME: ELETRIPTAN HYDROBROMIDE; NAT. REGISTRATION NO/DATE: NL 26625 20011105; FIRST REGISTRATION: LI - IKS 55218 20001214
/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
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
0592438/01Switzerland► SubscribeFORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Deloitte
McKinsey
US Department of Justice
Chubb
Chinese Patent Office
QuintilesIMS
Express Scripts
UBS
Merck

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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