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REMODULIN Drug Profile
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When do Remodulin patents expire, and what generic alternatives are available?
Remodulin is a drug marketed by United Therap and is included in two NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.
This drug has sixty-three patent family members in nine countries.
The generic ingredient in REMODULIN is treprostinil. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Remodulin
A generic version of REMODULIN was approved as treprostinil by SANDOZ INC on November 30th, 2017.
Summary for REMODULIN
| International Patents: | 63 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 27 |
| Patent Applications: | 2,093 |
| Drug Prices: | Drug price information for REMODULIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REMODULIN |
| What excipients (inactive ingredients) are in REMODULIN? | REMODULIN excipients list |
| DailyMed Link: | REMODULIN at DailyMed |
Recent Clinical Trials for REMODULIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rhode Island Hospital | Phase 1/Phase 2 |
| United Therapeutics | Phase 1/Phase 2 |
| University of Rhode Island | Phase 1/Phase 2 |
Pharmacology for REMODULIN
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
ATC Classes for REMODULIN
Paragraph IV (Patent) Challenges for REMODULIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| REMODULIN | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | treprostinil | 021272 | 2012-12-07 |
| REMODULIN | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | treprostinil | 021272 | 2011-12-02 |
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 | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-002 | Jul 30, 2018 | RX | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-004 | May 21, 2002 | AP | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-004 | Jul 30, 2018 | RX | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-003 | Jul 30, 2018 | RX | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-004 | Jul 30, 2018 | RX | No | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-004 | May 21, 2002 | AP | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| >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 REMODULIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-004 | May 21, 2002 | Try Before You Buy | Try Before You Buy |
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-004 | May 21, 2002 | Try Before You Buy | Try Before You Buy |
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-001 | May 21, 2002 | Try Before You Buy | Try Before You Buy |
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-003 | May 21, 2002 | Try Before You Buy | Try Before You Buy |
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-002 | May 21, 2002 | Try Before You Buy | Try Before You Buy |
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-001 | May 21, 2002 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for REMODULIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5043433 | Try Before You Buy |
| Spain | 2347254 | Try Before You Buy |
| Canada | 2698721 | Try Before You Buy |
| China | 101265226 | Try Before You Buy |
| Japan | 2014114317 | Try Before You Buy |
| Canada | 2851309 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
