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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Cerilliant
Express Scripts
Covington
Federal Trade Commission
Chubb
Harvard Business School
Chinese Patent Office
Cantor Fitzgerald
UBS

Generated: January 20, 2018

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Darifenacin hydrobromide - Generic Drug Details

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What are the generic sources for darifenacin hydrobromide and what is the scope of darifenacin hydrobromide patent protection?

Darifenacin hydrobromide
is the generic ingredient in three branded drugs marketed by Macleods Pharms Ltd, Anchen Pharms, Aurobindo Pharma Ltd, Cipla Ltd, Jubilant Generics, Torrent Pharms Ltd, and Apil, and is included in seven NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Darifenacin hydrobromide has forty-eight patent family members in thirty-one countries.

There are nineteen drug master file entries for darifenacin hydrobromide. Eleven suppliers are listed for this compound.
Summary for darifenacin hydrobromide
Pharmacology for darifenacin hydrobromide

US Patents and Regulatory Information for darifenacin hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant Generics DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 205550-002 Oct 12, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cipla Ltd DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207664-002 Sep 1, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Anchen Pharms DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 091190-001 Mar 13, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Torrent Pharms Ltd DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 205209-002 Nov 17, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Cipla Ltd DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207664-001 Sep 1, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Macleods Pharms Ltd DARIFENACIN darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207302-002 Jul 28, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma Ltd DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 206743-002 Sep 19, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma Ltd DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 206743-001 Sep 19, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Torrent Pharms Ltd DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 205209-001 Nov 17, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for darifenacin hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ➤ Subscribe ➤ Subscribe
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ➤ Subscribe ➤ Subscribe
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ➤ Subscribe ➤ Subscribe
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for darifenacin hydrobromide

Country Document Number Estimated Expiration
Japan 3403203 ➤ Subscribe
Norway 314783 ➤ Subscribe
Czech Republic 294024 ➤ Subscribe
Brazil 9610153 ➤ Subscribe
China 1195984 ➤ Subscribe
Australia 6927596 ➤ Subscribe
Poland 185604 ➤ Subscribe
Japan H10511112 ➤ Subscribe
Spain 2188782 ➤ Subscribe
Cyprus 2585 ➤ Subscribe
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for darifenacin hydrobromide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00191 Netherlands ➤ Subscribe PRODUCT NAME: DARIFENACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROBROMIDE; REGISTRATION NO/DATE: EU1/04/294/001 - 012, 20041022
C/GB05/022 United Kingdom ➤ Subscribe PRODUCT NAME: DARIFENACIN HYDROBROMIDE; REGISTERED: UK EU/1/04/294/001 20041022; UK EU/1/04/294/002 20041022; UK EU/1/04/294/003 20041022; UK EU/1/04/294/004 20041022; UK EU/1/04/294/005 20041022; UK EU/1/04/294/006 20041022; UK EU/1/04/294/007 20041022; UK EU/1/04/294/008 20041022; UK EU/1/04/294/009 20041022; UK EU/1/04/294/010 20041022; UK EU/1/04/294/011 20041022; UK EU/1/04/294/012 20041022
0190 Netherlands ➤ Subscribe 300190, 20160821, EXPIRES: 20191021
C0017 France ➤ Subscribe PRODUCT NAME: DARIFENACINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI CI; REGISTRATION NO/DATE IN FRANCE: EU/1/04/294/001 DU 20041022; REGISTRATION NO/DATE AT EEC: EU/01/04/294/001-012 DU 20041022
163 Luxembourg ➤ Subscribe 91163, EXPIRES: 20191022
/2005 Austria ➤ Subscribe PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001- EU/1/04/294/012 20041022
0850059/01 Switzerland ➤ Subscribe FORMER OWNER: NOVARTIS AG, CH
C012/2005 Ireland ➤ Subscribe SPC012/2005, 20060725, EXPIRES: 20191021
/2005 Austria ➤ Subscribe PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH ANNEHEMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001 - EU/1/04/294/012 20041022
2005 00020 Denmark ➤ Subscribe
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Cipla
Mallinckrodt
Federal Trade Commission
Medtronic
AstraZeneca
Healthtrust
Fuji
McKesson
McKinsey

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