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-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 | METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 209272-003 | Aug 15, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Lupin | MIBELAS 24 FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 206287-001 | May 24, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin | CEFUROXIME AXETIL | cefuroxime axetil | TABLET;ORAL | 065135-001 | Jul 25, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Pharms | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 208021-001 | Sep 20, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | QUETIAPINE FUMARATE | quetiapine fumarate | TABLET;ORAL | 201109-001 | Mar 27, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | VALSARTAN | valsartan | TABLET;ORAL | 201677-002 | Jan 5, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Lupin Ltd | LAMOTRIGINE | lamotrigine | TABLET;ORAL | 078691-002 | Jun 1, 2010 | 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 | 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 | 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 |
|---|---|---|
| Japan | 2020019759 | ⤷ Try a Trial |
| Russian Federation | 2747757 | ⤷ Try a Trial |
| Austria | 324364 | ⤷ Try a Trial |
| Australia | 2013226073 | ⤷ Try a Trial |
| China | 101959508 | ⤷ Try a Trial |
| Eurasian Patent Organization | 031355 | ⤷ Try a Trial |
| Portugal | 1671942 | ⤷ 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 |
|---|---|---|---|---|
| 3150586 | LUC00156 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925 |
| 0904081 | SPC/GB11/044 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304 |
| 0716606 | C300080 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SEVELAMER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SEVELAMER HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/99/123/001-00420000128 20000128 |
| 0641330 | 2004C/022 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708 |
| 1131065 | C300675 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 2435025 | 300995 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER GLYCOPYRRONIUYM BROMIDE, EN FORMOTEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER FORMOTEROL FUMARAAT DIHYDRAAT; REGISTRATION NO/DATE: EU/ 1/18/1339 20181220 |
| 1499331 | SPC/GB13/034 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
| >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.
