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Serving leading biopharmaceutical companies globally:

Colorcon
Queensland Health
US Department of Justice
Daiichi Sankyo
Cantor Fitzgerald
Healthtrust
Dow
Argus Health
Express Scripts
McKesson

Generated: January 16, 2018

DrugPatentWatch Database Preview

Remodulin Drug Profile

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When do Remodulin patents expire, and when can generic versions of Remodulin launch?

Remodulin is a drug marketed by United Therap and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-nine patent family members in eleven countries.

The generic ingredient in REMODULIN is treprostinil. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
Summary for Remodulin
International Patents:69
US Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 19
Clinical Trials: 23
Patent Applications: 153
Drug Prices:see details
DailyMed Link:Remodulin at DailyMed
Drug patent expirations by year for Remodulin
Pharmacology for Remodulin
Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation

US Patents and Regulatory Information for Remodulin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Remodulin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for REMODULIN
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial ➤ Subscribe 12/7/2012
➤ Subscribe Injection 10 mg/mL, 20 mL vial ➤ Subscribe 12/2/2011

Non-Orange Book US Patents for Remodulin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,748,657 Process to prepare treprostinil ➤ Subscribe
7,544,713 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
9,624,156 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives ➤ Subscribe
8,536,363 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
8,410,169 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
8,232,316 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
8,765,813 Use of treprostinil to treat and prevent ischemic lesions ➤ Subscribe
8,252,839 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
9,050,311 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for Remodulin

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Accenture
Baxter
AstraZeneca
Express Scripts
US Department of Justice
McKinsey
Harvard Business School
Citi

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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