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Last Updated: August 9, 2020

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ROWASA Drug Profile

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When do Rowasa patents expire, and when can generic versions of Rowasa launch?

Rowasa is a drug marketed by Mylan Speciality Lp and Meda Pharms and is included in two NDAs.

The generic ingredient in ROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

US ANDA Litigation and Generic Entry Outlook for Rowasa

A generic version of ROWASA was approved as mesalamine by PERRIGO ISRAEL on September 17th, 2004.

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Drug patent expirations by year for ROWASA
Drug Prices for ROWASA

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Recent Clinical Trials for ROWASA

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SponsorPhase
Colitis & Crohn's Foundation (India)Phase 3
Dayanand Medical College and HospitalPhase 3
Teva Pharmaceuticals USAPhase 1

See all ROWASA clinical trials

Pharmacology for ROWASA
Drug ClassAminosalicylate

US Patents and Regulatory Information for ROWASA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Meda Pharms ROWASA mesalamine SUPPOSITORY;RECTAL 019919-001 Dec 18, 1990 DISCN Yes No   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

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Dow
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Johnson and Johnson
Medtronic
Mallinckrodt

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