Generic for Remodulin: Treprostinil

Yes. The generic name for Remodulin is treprostinil. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 12 Remodulin products the Orange Book lists.

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Remodulin products in the Orange Book

Remodulin products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, intravenous, subcutaneous	0.1MG/ML	Discontinued	None	0	None
injectable, intravenous, subcutaneous	0.2MG/ML	Discontinued	None	0	None
injectable, intravenous, subcutaneous	0.4MG/ML	Marketed (Rx)	None	0	None
injectable, intravenous, subcutaneous	10MG/ML	Marketed (Rx)	AP	4	AP
injectable, intravenous, subcutaneous	1MG/ML	Marketed (Rx)	AP	4	AP
injectable, intravenous, subcutaneous	2.5MG/ML	Marketed (Rx)	AP	4	AP
injectable, intravenous, subcutaneous	20MG/ML	Discontinued	None	0	None
injectable, intravenous, subcutaneous	5MG/ML	Marketed (Rx)	AP	4	AP
solution, intravenous, subcutaneous	100MG/20ML (5MG/ML)	Discontinued	None	0	None
solution, intravenous, subcutaneous	200MG/20ML (10MG/ML)	Discontinued	None	0	None
solution, intravenous, subcutaneous	20MG/20ML (1MG/ML)	Discontinued	None	0	None
solution, intravenous, subcutaneous	50MG/20ML (2.5MG/ML)	Discontinued	None	0	None

NDA 021272, 208276, held by UNITED THERAPEUTICS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic treprostinil

Approved generic versions of Remodulin
Company	ANDA	TE code	Approved	Strengths
SANDOZ INC	203649	AP (A-rated, therapeutically equivalent)	November 30, 2017	10MG/ML, 1MG/ML, 2.5MG/ML, 5MG/ML
TEVA PHARMACEUTICALS USA	206648	AP (A-rated, therapeutically equivalent)	September 26, 2019	10MG/ML, 1MG/ML, 2.5MG/ML, 5MG/ML
DR REDDYS LABORATORIES LTD	210214	AP (A-rated, therapeutically equivalent)	May 22, 2020	10MG/ML, 1MG/ML, 2.5MG/ML, 5MG/ML
ALEMBIC GLOBAL HOLDING SA	211574	AP (A-rated, therapeutically equivalent)	February 11, 2021	10MG/ML, 1MG/ML, 2.5MG/ML, 5MG/ML

Remodulin patents

Patents listed for Remodulin
Patent	Expires	Covers	Use code	NDA
8658694	September 5, 2028	Method of use	U-1437	021272
8653137	September 5, 2028	Method of use	U-1437	021272
11723887	December 15, 2028	Drug substance	None	021272
9593066	December 15, 2028	Drug substance	None	021272
7999007	March 29, 2029	Drug product	U-1437	021272

Remodulin NDC codes

Questions

Is there a generic for Remodulin?

Yes. The generic name for Remodulin is treprostinil. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 12 Remodulin products the Orange Book lists.

What is the generic name for Remodulin?

The active ingredient in Remodulin is treprostinil, per the FDA Orange Book.

When does the Remodulin patent expire?

The last patent listed for Remodulin in the Orange Book expires March 29, 2029. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

Generic for Remodulin