Lupin Company Profile
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What is the competitive landscape for LUPIN, and when can generic versions of LUPIN drugs launch?
LUPIN has two hundred and thirty-one approved drugs.
There are nineteen US patents protecting LUPIN drugs. There are twenty-two tentative approvals on LUPIN drugs.
There are ninety-nine patent family members on LUPIN drugs in twenty-four countries and six hundred and seventy-eight supplementary protection certificates in seventeen countries.
Summary for Lupin
| International Patents: | 99 |
| US Patents: | 19 |
| Tradenames: | 189 |
| Ingredients: | 169 |
| NDAs: | 231 |
| Patent Litigation for Lupin: | See patent lawsuits for Lupin |
| PTAB Cases with Lupin as petitioner: | See PTAB cases with Lupin as petitioner |
Drugs and US Patents for Lupin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | POTASSIUM CHLORIDE | potassium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 203002-001 | Dec 18, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE | abacavir sulfate; lamivudine; zidovudine | TABLET;ORAL | 202912-001 | Dec 5, 2013 | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Lupin Ltd | ARMODAFINIL | armodafinil | TABLET;ORAL | 200751-001 | Nov 28, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin | DRONEDARONE HYDROCHLORIDE | dronedarone hydrochloride | TABLET;ORAL | 205904-001 | Jan 31, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a 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 Lupin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | 4,800,079 | ⤷ Try a Trial |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | 5,605,674 | ⤷ Try a Trial |
| Lupin | BROVANA | arformoterol tartrate | SOLUTION;INHALATION | 021912-001 | Oct 6, 2006 | 6,866,839 | ⤷ Try a Trial |
| Lupin | BROVANA | arformoterol tartrate | SOLUTION;INHALATION | 021912-001 | Oct 6, 2006 | 6,814,953 | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for LUPIN drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
| ➤ Subscribe | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
| ➤ Subscribe | Injection | 250 mcg/0.5 mL, 1 mL PFS | ➤ Subscribe | 2012-03-30 |
| ➤ Subscribe | Inhalation Solution | Eq. 0.015 mg base/2 mL | ➤ Subscribe | 2009-10-01 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ Subscribe | for Oral Suspension | 500 mg/5 mL | ➤ Subscribe | 2014-07-22 |
International Patents for Lupin Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1572622 | ⤷ Try a Trial |
| Australia | 2018203882 | ⤷ Try a Trial |
| Japan | 2020019759 | ⤷ Try a Trial |
| China | 105288650 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Lupin Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0740668 | PA2003001 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328 |
| 1718641 | 2012/008 | Ireland | ⤷ Try a Trial | PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209 |
| 0253310 | SPC/GB95/010 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215 |
| 1948158 | 16C0018 | France | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
