Assyro AI

FDA Orange Book · active-ingredient family

Methyltestosterone

Methyltestosterone is approved as 2 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:METANDREN · NDA 003240

2

Brand (NDA)

34

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
METANDREN×4NOVARTISNDA 003240—Approved Prior to Jan 1, 1982
ORETON METHYL×2SCHERINGNDA 003158—Approved Prior to Jan 1, 1982

Generic (ANDA) products (34)

ProductApplicantApplicationTEApproved
METHYLTESTOSTERONENOVITIUM PHARMAANDA 215270ABFeb 18, 2022
METHYLTESTOSTERONEIMPAX LABS INCANDA 204851ABSep 21, 2015
METHYLTESTOSTERONELANNETTANDA 087111—Jan 27, 1983
VIRILONCHARTWELLANDA 087750—Nov 24, 1982
METHYLTESTOSTERONELANNETTANDA 087092—Nov 05, 1982
METHYLTESTOSTERONEHEATHERANDA 084967—Approved Prior to Jan 1, 1982
TESTREDRLDBAUSCHANDA 083976—Approved Prior to Jan 1, 1982
ANDROID 5VALEANT PHARM INTLANDA 087222—Approved Prior to Jan 1, 1982
ORETONSCHERINGANDA 080281—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEIMPAX LABSANDA 084287—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONE×2LILLYANDA 080256—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEPUREPAC PHARMANDA 080308—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONE×3PUREPAC PHARMANDA 080475—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEPVT FORMANDA 083836—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONETABLICAPSANDA 085125—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEUSL PHARMAANDA 080271—Approved Prior to Jan 1, 1982
ANDROID 10VALEANT PHARMS NORTHANDA 086450—Approved Prior to Jan 1, 1982
ANDROID 25BAUSCHANDA 087147—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEIMPAX LABSANDA 080767BPApproved Prior to Jan 1, 1982
METHYLTESTOSTERONEIMPAX LABSANDA 084310—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEINWOOD LABSANDA 080839—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEINWOOD LABSANDA 080973—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEKV PHARMANDA 084312—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEPARKE DAVISANDA 084244—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEPARKE DAVISANDA 084241—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEPUREPAC PHARMANDA 080309—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEPUREPAC PHARMANDA 080310—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONE×3PVT FORMANDA 080214—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONETABLICAPSANDA 080313—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONETABLICAPSANDA 085270—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEWATSON LABSANDA 080933—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEWATSON LABSANDA 080931—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONE×2WEST WARDANDA 084331—Approved Prior to Jan 1, 1982
METHYLTESTOSTERONEWEST WARDANDA 084642—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Methyltestosterone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo