Treprostinil - Generic Drug Details

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What are the generic drug sources for treprostinil and what is the scope of freedom to operate?

Treprostinil is the generic ingredient in five branded drugs marketed by United Therap, Alembic Global, Dr Reddys, Endo Operations, Sandoz, and Teva Pharms Usa, and is included in ten NDAs. There are twenty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil has one hundred and eighty-eight patent family members in twenty-two countries.

There are nineteen drug master file entries for treprostinil. Six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for treprostinil

International Patents:	188
US Patents:	29
Tradenames:	5
Applicants:	6
NDAs:	10
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	105
Patent Applications:	2,516
Drug Prices:	Drug price trends for treprostinil
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for treprostinil
What excipients (inactive ingredients) are in treprostinil?	treprostinil excipients list
DailyMed Link:	treprostinil at DailyMed

See drug prices for treprostinil

Recent Clinical Trials for treprostinil

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Insmed Incorporated	Phase 2/Phase 3
Mayo Clinic	Phase 2
Ohio State University	Phase 2

See all treprostinil clinical trials

Generic filers with tentative approvals for TREPROSTINIL

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	2.5MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS
⤷ Sign Up	⤷ Sign Up	1MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS
⤷ Sign Up	⤷ Sign Up	0.4MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for treprostinil

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for treprostinil

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for TREPROSTINIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TYVASO	Inhalation Solution	treprostinil	0.6 mg/mL, 2.9 mL ampules	022387	1	2015-04-13
REMODULIN	Injection	treprostinil	1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial	021272	1	2012-12-07
REMODULIN	Injection	treprostinil	10 mg/mL, 20 mL vial	021272	1	2011-12-02

US Patents and Regulatory Information for treprostinil

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-002	Jul 30, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for treprostinil

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-001	May 21, 2002	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-001	May 21, 2002	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-006	Sep 28, 2023	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for treprostinil

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
SciPharm Sàrl	Trepulmix	treprostinil	EMEA/H/C/005207 Treatment of adult patients with WHO Functional Class (FC) III or IV and:inoperable chronic thromboembolic pulmonary hypertension (CTEPH), orpersistent or recurrent CTEPH after surgical treatmentto improve exercise capacity.	Authorised	no	no	yes	2020-04-03
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for treprostinil

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Country	Patent Number	Title	Estimated Expiration
Canada	2710205	PROCEDE AMELIORE DE PREPARATION DE TREPROSTINIL, L'INGREDIENT ACTIF DANS LE REMODULIN (AN IMPROVED PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN)	⤷ Sign Up
Poland	2322180		⤷ Sign Up
China	101827612	Buffer solutionsha ving selective bactericidal activity against gramnegative bacteria and methods of using same	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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