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PRALATREXATE

ANDA

PRALATREXATE | A206183 | DR REDDYS LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: FOLOTYN(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ALLOS THERAPEUTICS, INC. et al v. DR. REDDY'S LABORATORIES, INC. et al 1:2014cv04273 3 patentsANDA 206183pralatrexate	D.N.J.	2014-07-07	Terminated 2014-08-05	—

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

API Supply Chain3 active DMFs

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

HETERO LABS LTDPRALATREXATE

DMF 272322013

TAPI NL BVPRALATREXATE

DMF 272982013

GLAND PHARMA LTDPRALATREXATE

DMF 426312025

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

Products (2)

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#001 — 20MG/ML (20MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Mar 10, 2025

No patent or exclusivity listings for this strength.

#002 — 40MG/2ML (20MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Mar 10, 2025