Viewing data from:

MORPHABOND ER

NDA

MORPHINE SULFATE | N206544 | OHEMO LIFE SCIENCES INC

4 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

Today

7955619

Aug. 12, 2028

10314788

Aug. 12, 2028

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
OHEMO LIFE SCIENCES, INC. v. TEVA PHARMACEUTICALS USA, INC. et al 2:2019cv10464 1 patentANDA 212900morphine sulfate	D.N.J.	2019-04-19	Terminated 2020-08-24	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

11 letters from Drugs@FDA

Date	Submission	Document
Oct 8, 2019	SUPPL -12	View Letter (PDF)
Feb 4, 2019	SUPPL -9	View Letter (PDF)
Oct 1, 2018	SUPPL -10	View Letter (PDF)
Oct 1, 2018	SUPPL -8	View Letter (PDF)
Jun 4, 2018	SUPPL -7	View Letter (PDF)
May 31, 2017	SUPPL -6	View Letter (PDF)
Dec 21, 2016	SUPPL -5	View Letter (PDF)
Dec 21, 2016	SUPPL -2	View Letter (PDF)
Oct 3, 2016	SUPPL -4	View Letter (PDF)
Apr 22, 2016	SUPPL -1	View Letter (PDF)
Oct 9, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 15MG

RLD

2 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 2, 2015

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7955619	Aug 12, 2028	—	—	Yes	—	—
10314788	Aug 12, 2028	—	—	Yes	—	—

#002 — 30MG

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 2, 2015

#003 — 60MG

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 2, 2015

#004 — 100MG

RLD

2 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 2, 2015