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REMODULIN Drug Profile
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 eight patents protecting this drug and two Paragraph IV challenges.
This drug has fifty-seven patent family members in nine countries.
The generic ingredient in REMODULIN is treprostinil. There are eighteen 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: | 57 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 44 |
| Clinical Trials: | 24 |
| Patent Applications: | 428 |
| Drug Prices: | Drug price information for REMODULIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REMODULIN |
| DailyMed Link: | REMODULIN at DailyMed |
Pharmacology for REMODULIN
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
Synonyms for REMODULIN
| ((1R,2R,3aS,9aS)-2-hydroxy-1-((3S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cylopent(b)naphthalen-5-yl)oxy)acetate |
| ({(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl}oxy)acetic acid |
| (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy- 1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl] oxy]acetic acid |
| [[(1R,2R,3aS,9aS)-2-Hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphtalen-5-yl]oxy]acetic acid |
| [[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(S)-3-hydroxyoctyl]-1H-benzo[f]indene-5-yl]oxy]acetic acid |
| [[(1R,2R,3aS,9aS)-2,3,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid |
| [1R-[1|A(S*),2|A,3a|A,9a|A]]-[[2,3,3a,4,9,9a-| section signexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz[f]inden-5-yl]oxy]acetic Acid |
| 15 AU81 |
| 15AU |
| 15AU81 |
| 2-(((1R,2R,3aS,9aS)-2-hydroxy-1-((S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl)oxy)acetic acid |
| 2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-5-yl]oxy]acetic acid |
| 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic Acid |
| 2-[[(2R,3R,3aS,9aS)-2-hydroxy-3-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-8-yl]oxy]acetic acid |
| 2-{[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H,2H,3H,3aH,4H,9H,9aH-cyclopenta[b]naphthalen-5-yl]oxy}acetic acid |
| 2025AH |
| 289480-64-4 |
| 289480-64-4 (Sodium salt) |
| 81846-19-7 |
| AC1OCF2J |
| Acetic acid, (((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)- |
| Acetic acid, ((2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, (1R-(1alpha(S*),2beta,3aalpha,9aalpha))- |
| AKOS027470173 |
| BRD-K19706299-001-01-4 |
| BW 15AU |
| C23H33O5.Na |
| CHEBI:50861 |
| CHEMBL1237119 |
| CS-7872 |
| CTK8G3571 |
| D01WUA |
| D06213 |
| DB00374 |
| EX-A1414 |
| GTPL5820 |
| HMS3648G07 |
| HY-100441 |
| LRX 15 |
| LRX-15 |
| MolPort-027-720-928 |
| Orenitram |
| PAJMKGZZBBTTOY-ZFORQUDYSA-N |
| Remodulin (TN) |
| RP17714 |
| RUM6K67ESG |
| SCHEMBL4349618 |
| SR-01000946210 |
| SR-01000946210-1 |
| treprost |
| Treprostinil |
| Treprostinil (JAN/USAN/INN) |
| Treprostinil (USAN/INN) |
| Treprostinil [USAN:INN] |
| Treprostinil pound>>UT-15 |
| Treprostinil sodium |
| treprostinilo |
| treprostinilum |
| Tresprostinil |
| Trevyent |
| Tyvaso |
| U 62840 |
| U-62,840 |
| UNII-RUM6K67ESG |
| Uniprost |
| UT-15 |
| Viveta |
| Y0243 |
| ZINC3800475 |
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 | 208276-003 | Jul 30, 2018 | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ 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 | 208276-004 | Jul 30, 2018 | RX | No | 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 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 | ➤ Sign Up | ➤ Sign Up |
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-003 | May 21, 2002 | ➤ Sign Up | ➤ Sign Up |
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-003 | May 21, 2002 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for REMODULIN
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Injection | 10 mg/mL, 20 mL vial | ➤ Subscribe | ➤ Sign Up |
International Patents for REMODULIN
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 101161889 | ➤ Sign Up |
| European Patent Office | 2200650 | ➤ Sign Up |
| Japan | 2014114317 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
