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Moodys
Baxter
Queensland Health
McKesson
US Army
Julphar
Mallinckrodt
Express Scripts
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Generated: September 24, 2018

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ACTOPLUS MET Drug Profile

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When do Actoplus Met patents expire, and what generic alternatives are available?

Actoplus Met is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are thirteen patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in ACTOPLUS MET is metformin hydrochloride; pioglitazone hydrochloride. There are forty-eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.

US Patents and Regulatory Information for ACTOPLUS MET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-001 Aug 29, 2005 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 ACTOPLUS MET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-002 Aug 29, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-001 Aug 29, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-001 Aug 29, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ACTOPLUS MET
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 15 mg/1000 mg and 30 mg/1000 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 15 mg/500 mg and 15 mg/850 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for ACTOPLUS MET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012022 Lithuania ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1506211/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
77; 5006-2008 Slovakia ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Baxter
Queensland Health
McKesson
US Army
Julphar
Mallinckrodt
Express Scripts
Cerilliant

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