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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Teva
QuintilesIMS
Harvard Business School
Medtronic
Johnson and Johnson
Deloitte
McKinsey
Express Scripts

Generated: October 15, 2018

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BUNAVAIL Drug Profile

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

Bunavail is a drug marketed by Bdsi and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

US Patents and Regulatory Information for BUNAVAIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 BUNAVAIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for BUNAVAIL
Drugname Dosage Strength RLD Date
➤ Subscribe Buccal Film 2.1mg/0.3 mg and 4.2 mg/0.7 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Buccal Film 6.3 mg/1 mg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Teva
QuintilesIMS
Harvard Business School
Medtronic
Johnson and Johnson
Deloitte
McKinsey
Express Scripts

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