Lupin Company Profile
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What is the competitive landscape for LUPIN, and what generic alternatives to LUPIN drugs are available?
LUPIN has two hundred and thirty-one approved drugs.
There are nineteen US patents protecting LUPIN drugs. There are twenty-three tentative approvals on LUPIN drugs.
There are ninety-nine patent family members on LUPIN drugs in twenty-four countries and six hundred and seventy-seven 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 | BRIVARACETAM | brivaracetam | TABLET;ORAL | 214918-005 | Dec 20, 2022 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Lupin | SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | TABLET;ORAL | 077670-003 | Feb 6, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | LURASIDONE HYDROCHLORIDE | lurasidone hydrochloride | TABLET;ORAL | 208031-002 | Jan 3, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Pharms | ZIPRASIDONE HYDROCHLORIDE | ziprasidone hydrochloride | CAPSULE;ORAL | 077560-004 | Mar 2, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin | LEVOTHYROXINE SODIUM | levothyroxine sodium | TABLET;ORAL | 209713-007 | Jan 18, 2019 | AB1,AB2,AB3 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | OBETICHOLIC ACID | obeticholic acid | TABLET;ORAL | 214980-002 | May 30, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-002 | Nov 30, 2004 | DISCN | 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 | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | 5,439,670 | ⤷ Try a Trial |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | 5,547,994 | ⤷ Try a Trial |
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | 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 | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | 7,101,574 | ⤷ Try a Trial |
| Lupin | BROVANA | arformoterol tartrate | SOLUTION;INHALATION | 021912-001 | Oct 6, 2006 | 7,145,036 | ⤷ Try a Trial |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | 5,225,183 | ⤷ 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 | 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 |
| ➤ 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 |
International Patents for Lupin Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 110066351 | ⤷ Try a Trial |
| Canada | 3046521 | ⤷ Try a Trial |
| South Korea | 101166955 | ⤷ Try a Trial |
| Israel | 212369 | ⤷ Try a Trial |
| Denmark | 1671942 | ⤷ Try a Trial |
| Russian Federation | 2014136206 | ⤷ Try a Trial |
| Russian Federation | 2016140391 | ⤷ 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 |
|---|---|---|---|---|
| 1663240 | 300851 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
| 1632232 | SPC/GB17/008 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623 |
| 0810209 | C300283 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DARUNAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER DARUNAVIR ETHANOLAAT; REGISTRATION NO/DATE: EU/1/06/380/001 20070212 |
| 1663240 | 2015/054 | Ireland | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 2924034 | CA 2019 00024 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126 |
| 0748320 | SPC/GB08/021 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111 |
| 0810209 | SZ 33/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: DARUNAVIR UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE |
| >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.
