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-nine 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:	189
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
Mardi Gomberg -Maitland	Phase 2

See all treprostinil clinical trials

Generic filers with tentative approvals for TREPROSTINIL

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	0.4MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
⤷ Sign Up	⤷ Sign Up	0.2MG/ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
⤷ Sign Up	⤷ Sign Up	0.1MG/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	203496-001	Dec 20, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic Global	TREPROSTINIL	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	211574-003	Feb 11, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-002	May 23, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-007	Sep 28, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
United Therap	TYVASO DPI	treprostinil	POWDER;INHALATION	214324-003	May 23, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ 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;INTRAVENOUS, SUBCUTANEOUS	021272-008	Sep 28, 2023	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-003	May 21, 2002	⤷ Sign Up	⤷ Sign Up
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-007	Sep 28, 2023	⤷ Sign Up	⤷ Sign Up
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009	⤷ 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
South Korea	101306384		⤷ Sign Up
China	108578372	微晶二酮哌嗪组合物以及方法 (Microcrystalline diketopiperazine compositions and methods)	⤷ Sign Up
Spain	2562669		⤷ Sign Up
South Korea	20170081292	레모둘린?의 활성 성분인 트레프로스티닐의 개선된 제조 방법 (? AN IMPROVED PROCESS TO PREPARE TREPROSTINIL THE ACTIVE INGREDIENT IN REMODULIN?)	⤷ Sign Up
China	1917866	Use of treprostinil to treat and prevent ischemic lesions	⤷ Sign Up
Japan	2019112450	結晶性ジケトピペラジン組成物 (CRYSTALLINE DIKETOPIPERAZINE COMPOSITIONS)	⤷ Sign Up
Mexico	2015013017	COMPOSICIONES DE DICETOPIPERAZINA MICROCRISTALINA Y METODOS. (MICROCRYSTALLINE DIKETOPIPERAZINE COMPOSITIONS AND METHODS.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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