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AVINZA

NDA

MORPHINE SULFATE | N021260 | KING PHARMACEUTICALS LLC

6 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Morphine Sulfate (J2270) (2023)

Total Spending

$45K

Total Claims

6,007

Beneficiaries

3,441

ASP Price

—

Spending Trend

$45K(2023)→$1K(2023)

HCPCS: J2270 — Injection, morphine sulfate, up to 10 mg

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

API Supply Chain3 active DMFs5 inactive

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

SPECGX LLCMORPHINE SULFATE

DMF 58571985

NORAMCO LLCMORPHINE SULFATE

DMF 69671987

VERANOVA LPMORPHINE SULFATE USP

DMF 215882008

PENICK CORPInactiveMORPHINE SULFATE

DMF 66801986

MACFARLAN SMITH LTDInactiveMORPHINE SULFATE

DMF 83281989

MALLINCKRODT INCInactiveMORPHINE SULFATE INJECTION USP

DMF 115291995

ELAN PHARMA LTDInactiveMORPHINE SULFATE

DMF 128081997

SIEGFRIED USA LLCInactiveMORPHINE SULFATE USP

DMF 196932006

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jul 6, 2015	SUPPL -24	View Letter (PDF)
Aug 20, 2014	SUPPL -23	View Letter (PDF)
Apr 17, 2014	SUPPL -22	View Letter (PDF)
May 8, 2013	SUPPL -17	View Letter (PDF)
Apr 16, 2013	SUPPL -18	View Letter (PDF)
Jul 11, 2012	SUPPL -16	View Letter (PDF)
Jul 11, 2012	SUPPL -15	View Letter (PDF)
Dec 23, 2008	SUPPL -13	View Letter (PDF)
Oct 25, 2005	SUPPL -6	View Letter (PDF)
Mar 20, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 30MG

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 20, 2002

No patent or exclusivity listings for this strength.

#002 — 60MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 20, 2002

#003 — 90MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 20, 2002

#004 — 120MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 20, 2002

#005 — 45MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Dec 18, 2008

#006 — 75MG

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Dec 18, 2008