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REMODULIN Drug Profile
Which patents cover Remodulin, 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 sixty-two 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.
US ANDA Litigation and Generic Entry Outlook for Remodulin
A generic version of REMODULIN was approved as treprostinil by SANDOZ INC on January 28th, 2020.
Summary for REMODULIN
| International Patents: | 62 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 27 |
| Patent Applications: | 527 |
| 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 |
Recent Clinical Trials for REMODULIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| United Therapeutics | Phase 1/Phase 2 |
| University of Rhode Island | Phase 1/Phase 2 |
| Rhode Island Hospital | Phase 1/Phase 2 |
Recent Litigation for REMODULIN
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| UNITED THERAPEUTICS CORPORATION v. WATSON LABORATORIES, INC. | 2015-07-22 |
| UNITED THERAPEUTICS CORPORATION v. TEVA PHARMACEUTICALS USA, INC. | 2014-09-02 |
| UNITED THERAPEUTICS CORPORATION v. SANDOZ, INC. | 2012-03-14 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| SteadyMed Ltd. | 2015-10-02 |
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 |
| 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-((s)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1h-cyclopenta[b]naphthalen-5-yloxy)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) |
| 7JZ75N2NT6 |
| 81846-19-7 |
| 81846-19-7 (Parent) |
| AC-30205 |
| AC-30207 |
| 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, (((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, monosodium salt |
| 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 |
| AKOS030524396 |
| API0005768 |
| ARD-1550 |
| BCP10253 |
| BRD-K19706299-001-01-4 |
| BW 15AU |
| BW-15AU |
| C23H33O5.Na |
| CHEBI:50861 |
| CHEBI:50863 |
| CHEMBL1237119 |
| CS-6170 |
| CS-7872 |
| CTK8G3571 |
| D06213 |
| D08628 |
| DB00374 |
| EX-A1414 |
| EX-A1416 |
| GTPL5820 |
| HMS3648G07 |
| HY-100441 |
| HY-16504 |
| LRX 15 |
| LRX-15 |
| MolPort-027-720-928 |
| Orenitram |
| PAJMKGZZBBTTOY-ZFORQUDYSA-N |
| Remodulin (TN) |
| RP17714 |
| RUM6K67ESG |
| Rumodolin |
| SCHEMBL4349618 |
| SCHEMBL61996 |
| sodium ({(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl}oxy)acetate |
| sodium 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)acetate |
| SR-01000946210 |
| SR-01000946210-1 |
| Treprostinil |
| Treprostinil (JAN/USAN/INN) |
| Treprostinil (sodium) |
| Treprostinil [USAN:INN] |
| Treprostinil monosodium salt |
| Treprostinil pound>>UT-15 |
| Treprostinil sodium |
| treprostinilo |
| treprostinilum |
| Tresprostinil |
| Trevyent |
| Tyvaso |
| U 62840 |
| U-62,840 |
| U-62840 |
| UNII-7JZ75N2NT6 |
| UNII-RUM6K67ESG |
| Uniprost |
| UT-15 |
| Viveta |
| Y0243 |
| ZINC3800475 |
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 | 208276-003 | Jul 30, 2018 | RX | No | No | Start Trial | Start Trial | Start Trial | ||||
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-004 | May 21, 2002 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| United Therap | REMODULIN | treprostinil | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 208276-004 | Jul 30, 2018 | RX | No | No | Start Trial | Start Trial | Start Trial | ||||
| >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 | 021272-001 | May 21, 2002 | Start Trial | Start Trial |
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-003 | May 21, 2002 | Start Trial | Start Trial |
| United Therap | REMODULIN | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 021272-002 | May 21, 2002 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for REMODULIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2014114317 | Start Trial |
| South Korea | 20160048222 | Start Trial |
| China | 101827612 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
