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Lisinopril - Generic Drug Details
What are the generic drug sources for lisinopril and what is the scope of freedom to operate?
Lisinopril
is the generic ingredient in four branded drugs marketed by Silvergate Pharms, Accord Hlthcare, Apotex Inc, Aurobindo, Casi Pharms Inc, Heritage Pharma, Hikma Intl Pharms, Invagen Pharms, Lupin, Mylan, Prinston Inc, Sandoz, Sun Pharm Inds Ltd, Teva, Watson Labs, Wockhardt, Merck, and Alvogen, and is included in twenty-one NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lisinopril has six patent family members in six countries.
There are twenty-one drug master file entries for lisinopril. Fifty-one suppliers are listed for this compound.
Summary for lisinopril
| International Patents: | 6 |
| US Patents: | 5 |
| Tradenames: | 4 |
| Applicants: | 18 |
| NDAs: | 21 |
| Drug Master File Entries: | 21 |
| Suppliers / Packagers: | 51 |
| Bulk Api Vendors: | 66 |
| Clinical Trials: | 98 |
| Patent Applications: | 6,510 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for lisinopril |
| Drug Sales Revenues: | Drug sales revenues for lisinopril |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lisinopril |
| DailyMed Link: | lisinopril at DailyMed |
Recent Clinical Trials for lisinopril
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited | Phase 1 |
| Chinese University of Hong Kong | Phase 1 |
| University of Leeds | Phase 2 |
Recent Litigation for lisinopril
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Apotex, Inc. v. Mylan Pharmaceuticals, Inc. | 2012-04-20 |
| Apotex, Inc. v. UCB, Inc. | 2012-04-20 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| KVK-Tech, Inc. | 2017-07-10 |
Pharmacology for lisinopril
| Drug Class | Angiotensin Converting Enzyme Inhibitor |
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for lisinopril
Synonyms for lisinopril
| (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-phenyl-propyl]amino]hexanoyl]proline;hydrate |
| (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-phenyl-propyl]amino]hexanoyl]pyrrolidine-2-carboxylic acid |
| (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]-1-oxohexyl]-2-pyrrolidinecarboxylic acid |
| (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]-1-oxohexyl]-2-pyrrolidinecarboxylic acid;hydrate |
| (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]hexanoyl]pyrrolidine-2-carboxylic acid;hydrate |
| (2S)-1-[(2S)-6-amino-2-[[(2S)-1-hydroxy-1-oxo-4-phenylbutan-2-yl]amino]hexanoyl]pyrrolidine-2-carboxylic acid |
| (2S)-1-[(2S)-6-amino-2-{[(1S)-1-carboxy-3-phenylpropyl]amino}hexanoyl]pyrrolidine-2-carboxylic acid |
| (2S)-1-[(2S)-6-azanyl-2-[[(2S)-1-oxidanyl-1-oxidanylidene-4-phenyl-butan-2-yl]amino]hexanoyl]pyrrolidine-2-carboxylic acid |
| (2S)-1-[(2S)-6-azanyl-2-[[(2S)-1-oxidanyl-1-oxidanylidene-4-phenyl-butan-2-yl]amino]hexanoyl]pyrrolidine-2-carboxylic acid;hydrate |
| (S)-1-((S)-6-Amino-2-(((S)-1-carboxy-3-phenylpropyl)amino)hexanoyl)pyrrolidine-2-carboxylic acid |
| (S)-1-((S)-6-amino-2-((S)-1-carboxy-3-phenylpropylamino)hexanoyl)pyrrolidine-2-carboxylic acid |
| (S)-1-(N(2)-(1-carboxy-3-phenylpropyl)-L-lysyl)-L-proline |
| (S)-1-(N(sup 2)-(1-Carboxy-3-phenylpropyl)-L-lysyl)-L-proline |
| (S)-1-(N2-(1-Carboxy-3-phenylpropyl)-L-lysyl)-L-proline |
| (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline |
| (S)-1-[N2-(1-Carboxy-3-phenylpropyl)-lysyl-proline dihydrate |
| [N2-[(S)-1-CARBOXY-3-PHENYLPROPYL]-L-LYSYL-L-PROLINE |
| 1-(N2-(1-Carboxy-3-phenylpropyl)-L-lysyl)-L-proline |
| 1-[Nalpha-[(S)-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline |
| 1835AH |
| 2517AH |
| 54256-EP2270011A1 |
| 54256-EP2272834A1 |
| 54256-EP2277879A1 |
| 54256-EP2287165A2 |
| 54256-EP2287166A2 |
| 54256-EP2292228A1 |
| 54256-EP2292620A2 |
| 54256-EP2298742A1 |
| 54256-EP2298776A1 |
| 54256-EP2298779A1 |
| 54256-EP2301923A1 |
| 54256-EP2301929A1 |
| 54256-EP2301931A1 |
| 54256-EP2301935A1 |
| 54256-EP2305648A1 |
| 54256-EP2305674A1 |
| 54256-EP2308562A2 |
| 547L983 |
| 76547-98-3 |
| 77726-95-5 |
| 7Q3P4BS2FD |
| 83915-83-7 |
| 83915-83-7 (Parent) |
| A838743 |
| AB00052250_14 |
| AB00052250_15 |
| AB00052250-13 |
| AB04852 |
| AC1NSFPF |
| Acerbon |
| Acercomp |
| AK322582 |
| AKOS015836369 |
| AKOS015894970 |
| Alapril |
| Amicor |
| AN-36890 |
| BCP9000856 |
| BDBM50367879 |
| BDBM66979 |
| BIDD:GT0755 |
| BPBio1_000290 |
| BRD-K67966701-335-03-5 |
| BRN 4276619 |
| BSPBio_000262 |
| C21H31N3O5 |
| Carace |
| CCG-39190 |
| CCRIS 3568 |
| CHEBI:43755 |
| CHEMBL1237 |
| cid_22887897 |
| Cipral |
| Cipril |
| Coric |
| CPD000544473 |
| CS-2443 |
| CTK5F1429 |
| D08131 |
| DB00722 |
| Diroton |
| DivK1c_001037 |
| DL-434 |
| Doneka |
| DTXSID6040537 |
| EINECS 278-488-1 |
| FT-0627878 |
| GTPL6360 |
| Hipril |
| HMS1921B14 |
| HMS2090O14 |
| HMS2092L21 |
| HMS2850N20 |
| HMS503O15 |
| HSDB 6852 |
| HY-18206 |
| I06-1895 |
| ICI-209K |
| IDI1_001037 |
| Inhibril |
| Inopril |
| Irumed |
| KBio1_001037 |
| KBio2_000977 |
| KBio2_003545 |
| KBio2_006113 |
| KBio3_002002 |
| KBioGR_001599 |
| KBioSS_000977 |
| KM1776 |
| KS-00000GHQ |
| KSC651I2T |
| L-Proline, 1-(N(sup 2)-(1-carboxy-3-phenylpropyl)-L-lysyl)-, (S)- |
| L-Proline, 1-(N2-(1-carboxy-3-phenylpropyl)-L-lysyl)- |
| L-Proline, 1-(N2-(1-carboxy-3-phenylpropyl)-L-lysyl)-, (S)- |
| L-Proline, N2-((1S)-1-carboxy-3-phenylpropyl)-L-lysyl- |
| L0220 |
| Laaven |
| Linopril |
| Linvas |
| Lipril |
| Lisinal |
| Lisinopril (anhydrous) |
| Lisinopril (INN) |
| Lisinopril (Zestril) |
| Lisinopril [INN] |
| Lisinopril anhydrous |
| Lisinoprilum |
| Lisinoprilum [Latin] |
| Lisipril |
| Lisitec |
| Lisopril |
| Lisoril |
| Lispril |
| Listril |
| Lizinopril |
| Lizonoton |
| Longes |
| Loril |
| LPR |
| LS-118899 |
| Lysinopril |
| lysinopryl |
| MCULE-7813362088 |
| MFCD01698825 |
| MK 521 |
| MK 522 |
| MK-521 |
| MLS001306436 |
| MLS001306481 |
| MLS002154258 |
| MolPort-002-507-428 |
| N-(1(S)-Carboxy-3-phenylpropyl)-L-lysyl-L-proline |
| N-[N2 -(1(S)-carboxy-3-phenylpropyl)-L-lysyl]-L-proline |
| N-[N2 (1(S)-carboxy-3-phenylpropyl)-L-lysyl]-L-proline |
| N(2)-[(1S)-1-carboxy-3-phenylpropyl]-L-lysyl-L-proline |
| N~2~-[(1S)-1-carboxy-3-phenylpropyl]-L-lysyl-L-proline |
| N2-((S)-1-Carboxy-3-phenylpropyl)-L-lysyl-L-proline |
| N2-[(1S)-1-carboxy-3-phenylpropyl]-L-lysyl-L-proline |
| Nanopril |
| NCGC00179623-01 |
| NINDS_001037 |
| Noperten |
| Novatec |
| NSC-751176 |
| NSC-758151 |
| NSC751176 |
| NSC758151 |
| Optimon |
| Pharmakon1600-01501217 |
| Presiten |
| Prestwick0_000301 |
| Prestwick1_000301 |
| Prestwick2_000301 |
| Prestwick3_000301 |
| Prinil |
| Prinivil |
| Prinvil |
| Qbrelis |
| RLAWWYSOJDYHDC-BZSNNMDCSA-N |
| s2076 |
| SAM002589993 |
| SBI-0051692.P002 |
| SC-18165 |
| SCHEMBL15680 |
| Sinopril |
| Sinopryl |
| Skopryl |
| SMR000544473 |
| SMR001233519 |
| SPBio_001351 |
| SPBio_002481 |
| Spectrum_000497 |
| SPECTRUM1501217 |
| Spectrum2_001456 |
| Spectrum3_000941 |
| Spectrum4_001040 |
| Spectrum5_000995 |
| SR-05000001786 |
| SR-05000001786-1 |
| Tensopril |
| Tensyn |
| Tersif |
| TL8005499 |
| UNII-7Q3P4BS2FD |
| Vitopril |
| Vivatec |
| Z2786051707 |
| Zestril |
| Zestril (TN) |
| ZINC3812863 |
US Patents and Regulatory Information for lisinopril
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alvogen | ZESTRIL | lisinopril | TABLET;ORAL | 019777-001 | May 19, 1988 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Invagen Pharms | LISINOPRIL | lisinopril | TABLET;ORAL | 203508-004 | Oct 29, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Alvogen | ZESTRIL | lisinopril | TABLET;ORAL | 019777-003 | May 19, 1988 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Casi Pharms Inc | LISINOPRIL | lisinopril | TABLET;ORAL | 075994-003 | Jul 1, 2002 | AB | 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 lisinopril
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck | PRINIVIL | lisinopril | TABLET;ORAL | 019558-004 | Oct 25, 1988 | Start Trial | Start Trial |
| Merck | PRINIVIL | lisinopril | TABLET;ORAL | 019558-006 | Jan 28, 1994 | Start Trial | Start Trial |
| Alvogen | ZESTRIL | lisinopril | TABLET;ORAL | 019777-002 | May 19, 1988 | Start Trial | Start Trial |
| Alvogen | ZESTRIL | lisinopril | TABLET;ORAL | 019777-003 | May 19, 1988 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lisinopril
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 108472252 | Start Trial |
| South Korea | 20180069907 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2017075368 | Start Trial |
| European Patent Office | 3368012 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.