Viewing data from:

BUTRANS

NDA

BUPRENORPHINE | N021306 | KNOA PHARMA LLC

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) FDA-2014-P-0205 Purdue Pharma LP filed this citizen petition requesting that the FDA exercise its authority under Section 505(o) of the Federal Food, Drug and Cosmetic Act to impose safety labeling changes on immediate-release opioid analgesics parallel to those mandated for extended-release and long-acting opioid	Other	2014-02-25	Partially Denied	Purdue Pharma LP (Kleinfeld

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Butrans (2023)

Total Spending

$23.2M

Total Claims

30,688

Beneficiaries

6,514

Avg Cost/Unit

$185.67

Spending Trend

$43.8M(2019)→$36.9M(2020)→$28.0M(2021)→$24.8M(2022)→$23.2M(2023)

YoY Change:+5.1%

5yr CAGR:+7.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Sublocade (Q9992) (2023)

Total Spending

$1.0M

Total Claims

645

Beneficiaries

201

ASP Price

—

Spending Trend

$1.0M(2023)→$1.0M(2023)

HCPCS: Q9992 — Injection, buprenorphine extended-release (sublocade), greater than 100 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain12 active DMFs3 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

INDIVIOR UK LTDBUPRENORPHINE HCI

DMF 124121997

NORAMCO LLCBUPRENORPHINE BASE (R371605) DRUG SUBSTANCE

DMF 236842010

SPECGX LLCBUPRENORPHINE BASE EP, CODE 3205

DMF 249282012

SIEGFRIED LTDBUPRENORPHINE

DMF 260522012

MACFARLAN SMITH LTD A JOHNSON MATTHEY COBUPRENORPHINE

DMF 264482012

AREVIPHARMA GMBHBUPRENORPHINE

DMF 275472013

TAPI NL BVBUPRENORPHINE

DMF 280752014

SIEGFRIED USA LLCBUPRENORPHINE

DMF 290912015

NORAMCO LLCBUPRENORPHINE HYDROCHLORIDE, USP

DMF 298852016

NORAMCO LLCBUPRENORPHINE

DMF 307622016

SUN PHARMACEUTICAL INDUSTRIES LTDBUPRENORPHINE BASE

DMF 330972019

CHR OLESEN SYNTHESIS ASBUPRENORPHINE HCl USP

DMF 359882021

DIOSYNTH BVInactiveBUPRENORPHINE

DMF 85421990

TASMANIAN ALKALOIDS PTY LTDInactiveBUPRENORPHINE BASE

DMF 118601996

TASMANIAN ALKALOIDS PROPRIETARY LTDInactiveBUPRENORPHINE BASE DRUG SUBSTANCE

DMF 151262000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Jun 23, 2026	SUPPL -45	View Letter (PDF)
Dec 31, 2025	SUPPL -44	View Letter (PDF)
Nov 4, 2024	SUPPL -42	View Letter (PDF)
Dec 19, 2023	SUPPL -41	View Letter (PDF)
Jun 21, 2022	SUPPL -39	View Letter (PDF)
Mar 5, 2021	SUPPL -37	View Letter (PDF)
Oct 8, 2019	SUPPL -35	View Letter (PDF)
Oct 1, 2018	SUPPL -32	View Letter (PDF)
Oct 1, 2018	SUPPL -34	View Letter (PDF)
Oct 18, 2017	SUPPL -27	View Letter (PDF)
Aug 21, 2017	SUPPL -31	View Letter (PDF)
Dec 20, 2016	SUPPL -24	View Letter (PDF)
Oct 4, 2016	SUPPL -26	View Letter (PDF)
Apr 22, 2016	SUPPL -23	View Letter (PDF)
Jul 6, 2015	SUPPL -22	View Letter (PDF)
Aug 20, 2014	SUPPL -20	View Letter (PDF)
Jul 1, 2014	SUPPL -19	View Letter (PDF)
Jul 1, 2014	SUPPL -15	View Letter (PDF)
Apr 17, 2014	SUPPL -18	View Letter (PDF)
Jul 29, 2013	SUPPL -16	View Letter (PDF)
Apr 16, 2013	SUPPL -12	View Letter (PDF)
Jul 11, 2012	SUPPL -8	View Letter (PDF)
Jul 7, 2011	SUPPL -3	View Letter (PDF)
Jul 7, 2011	SUPPL -1	View Letter (PDF)
Jul 2, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 5MCG/HR

RLDAB

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Jun 30, 2010

No patent or exclusivity listings for this strength.

#002 — 10MCG/HR

RLDAB

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Jun 30, 2010

#003 — 20MCG/HR

RLDAB

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Jun 30, 2010

#004 — 15MCG/HR

RLDAB

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Jul 25, 2013

#005 — 7.5MCG/HR

RLDAB

0 patents0 exclusivities▾

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Jun 30, 2014

Change History (10)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

KNOA Pharma LLC replaced Purdue Pharma LP as the listed applicant for Butrans (buprenorphine) NDA 021306.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC

MODIFIEDApplicant7/1/2026

KNOA PHARMA acquired ownership of the BUTRANS (buprenorphine) NDA from Purdue Pharma LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant Full Name7/1/2026

KNOA PHARMA LLC acquired the NDA for BUTRANS (buprenorphine) transdermal patch from Purdue Pharma LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC

MODIFIEDApplicant7/1/2026

KNOA Pharma acquired NDA 021306 for Butrans (buprenorphine) transdermal patch from Purdue Pharma LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant Full Name7/1/2026

KNOA Pharma LLC became the listed applicant for Butrans (buprenorphine transdermal patch, NDA 021306) following a change in ownership or application control from Purdue Pharma LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC

MODIFIEDApplicant Full Name7/1/2026

KNOA PHARMA LLC became the listed applicant for BUTRANS (buprenorphine) NDA 021306, replacing PURDUE PHARMA LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC

MODIFIEDApplicant7/1/2026

KNOA Pharma replaced Purdue Pharma LP as the applicant for BUTRANS (buprenorphine) NDA 021306.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant Full Name7/1/2026

Applicant for BUTRANS (buprenorphine) transdermal patch, NDA 021306, changed from Purdue Pharma LP to KNOA Pharma LLC.

Old: PURDUE PHARMA LP

New: KNOA PHARMA LLC

MODIFIEDApplicant7/1/2026

KNOA Pharma acquired NDA 021306 for BUTRANS (buprenorphine) transdermal patch from Purdue Pharma LP.

Old: PURDUE PHARMA LP

New: KNOA PHARMA

MODIFIEDApplicant7/1/2026

BUTRANS (buprenorphine) NDA 021306 applicant changed from Purdue Pharma LP to KNOA Pharma.

Old: PURDUE PHARMA LP

New: KNOA PHARMA