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PRANDIN

NDA

REPAGLINIDE | N020741 | GEMINI LABORATORIES LLC

3 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Novo Nordisk Inc. et al v. Paddock Laboratories, Inc. 0:2010cv02199 1 patentrepaglinide	MND	2010-05-28	Terminated 2011-08-30	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies NCT07340190	Phase 1	Recruiting	Novartis Pharmaceuticals	24	2026-06-12 → 2028-04-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain11 active DMFs5 inactive

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

DR REDDYS LABORATORIES LTDREPAGLINIDE

DMF 172452004

SUN PHARMACEUTICAL INDUSTRIES LTDREPAGLINIDE USP

DMF 178252004

USV PRIVATE LTDREPAGLINIDE USP

DMF 183292005

BIOCON LTDREPAGLINIDE

DMF 184822005

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGREPAGLINIDE

DMF 196202006

MACLEODS PHARMACEUTICALS LTDREPAGLINIDE

DMF 222342008

APITORIA PHARMA PRIVATE LTDREPAGLINIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 230682009

JUBILANT PHARMOVA LTDREPAGLINIDE USP

DMF 245192011

TORRENT PHARMACEUTICALS LTDREPAGLINIDE

DMF 256632012

CHROMO LABORATORIES INDIA PRIVATE LTDREPAGLINIDE USP

DMF 263962012

TIANJIN PHARMACEUTICAL HOLDINGS GENCOM PHARMACY CO LTDREPAGLINIDE

DMF 299222015

CHEMWERTH INCInactiveREPAGLINIDE USP

DMF 180032005

RANBAXY LABORATORIES LTDInactiveREPAGLINIDE USP

DMF 190102005

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDInactiveREPAGLINIDE

DMF 209992007

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveREPAGLINIDE

DMF 211492007

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDInactiveREPAGLINIDE

DMF 288382014

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Feb 13, 2019	SUPPL -44	View Letter (PDF)
Feb 9, 2017	SUPPL -42	View Letter (PDF)
Feb 9, 2017	SUPPL -41	View Letter (PDF)
Mar 5, 2012	SUPPL -40	View Letter (PDF)
Aug 3, 2010	SUPPL -38	View Letter (PDF)
Jun 16, 2009	SUPPL -35	View Letter (PDF)
Jul 15, 2008	SUPPL -34	View Letter (PDF)
Jun 28, 2006	SUPPL -30	View Letter (PDF)
Feb 11, 2005	SUPPL -22	View Letter (PDF)
Oct 17, 2003	SUPPL -19	View Letter (PDF)
Aug 29, 2003	SUPPL -18	View Letter (PDF)
Oct 21, 2002	SUPPL -13	View Letter (PDF)
Jan 18, 2002	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 22, 1997

No patent or exclusivity listings for this strength.

#002 — 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 22, 1997

#003 — 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 22, 1997