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METANDREN

NDA

METHYLTESTOSTERONE | N003240 | NOVARTIS PHARMACEUTICALS CORP

4 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

No ANDA patent litigation cases (NOS 835) matched from PACER

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.

ASPEN OSS BVMETHYLTESTOSTERONE

DMF 38611980

FARMABIOS SPAMETHYLTESTOSTERONE (MICRONIZED)

DMF 255932011

NOVITIUM PHARMA LLCMETHYLTESTOSTERONE USP

DMF 343732019

KV PHARMACEUTICAL COInactiveMETHYLTESTOSTERONE

DMF 23101974

ROUSSELL UCLAFInactiveMETHYLTESTOSTERONE USP

DMF 37751980

SCHERING AGInactiveMETHYLTESTOSTERONE

DMF 47041982

SYNTEX USA INCInactiveMETHYLTESTOSTERONE

DMF 66791986

HENAN QUANXIN MEDICAL CHEMICAL TECHNOLOGY CO LTDInactiveMETHYLTESTOSTERONE USP

DMF 188042005

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

Products (4)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;BUCCAL, SUBLINGUAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 25MG

0 patents0 exclusivities▾

TABLET;BUCCAL, SUBLINGUAL | Approved: Approved Prior to Jan 1, 1982

#004 — 5MG

0 patents0 exclusivities▾

TABLET;BUCCAL, SUBLINGUAL | Approved: Approved Prior to Jan 1, 1982

#005 — 10MG

0 patents0 exclusivities▾

TABLET;BUCCAL, SUBLINGUAL | Approved: Approved Prior to Jan 1, 1982