MYLAN Company Profile
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What is the competitive landscape for MYLAN, and what generic alternatives to MYLAN drugs are available?
MYLAN has four hundred and fifteen approved drugs.
There are forty-two US patents protecting MYLAN drugs. There are forty-three tentative approvals on MYLAN drugs.
There are two hundred and fifty-two patent family members on MYLAN drugs in forty-one countries and nine hundred and twenty supplementary protection certificates in eighteen countries.
Summary for MYLAN
| International Patents: | 252 |
| US Patents: | 42 |
| Tradenames: | 338 |
| Ingredients: | 311 |
| NDAs: | 415 |
| Patent Litigation for MYLAN: | See patent lawsuits for MYLAN |
| PTAB Cases with MYLAN as petitioner: | See PTAB cases with MYLAN as petitioner |
Drugs and US Patents for MYLAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | METAPROTERENOL SULFATE | metaproterenol sulfate | SOLUTION;INHALATION | 070804-001 | Aug 17, 1987 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Mylan | LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 091590-002 | Oct 6, 2010 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
| Mylan Labs Ltd | NALOXONE HYDROCHLORIDE | naloxone hydrochloride | INJECTABLE;INJECTION | 213843-001 | Jun 9, 2022 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Mylan Institutional | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 090270-001 | Jun 9, 2009 | AP | RX | No | Yes | ⤷ Subscribe | ⤷ Subscribe | ||||
| Mylan | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 201275-001 | Dec 6, 2021 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Mylan | PREDNISONE | prednisone | TABLET;ORAL | 080292-001 | Approved Prior to Jan 1, 1982 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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 MYLAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-004 | Nov 19, 1996 | 5,474,535 | ⤷ Subscribe |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-001 | Nov 19, 1996 | 5,773,020 | ⤷ Subscribe |
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 7,368,102 | ⤷ Subscribe |
| Mylan Speciality Lp | TOBI | tobramycin | SOLUTION;INHALATION | 050753-001 | Dec 22, 1997 | 5,508,269 | ⤷ Subscribe |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-004 | Nov 19, 1996 | 5,242,391 | ⤷ Subscribe |
| Mylan Speciality Lp | GASTROCROM | cromolyn sodium | CONCENTRATE;ORAL | 020479-001 | Feb 29, 1996 | 4,515,805 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for MYLAN drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
| ➤ Subscribe | Inhalation Solution | 300 mg/5 mL | ➤ Subscribe | 2009-06-29 |
| ➤ Subscribe | Nasal Spray | 137 mcg/50 mcg per spray | ➤ Subscribe | 2014-06-13 |
| ➤ Subscribe | CapsulesInhalation Solution | 0.02 mg/2 mL | ➤ Subscribe | 2009-01-21 |
| ➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
| ➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
| ➤ Subscribe | for Injection | 1 mg/vial, 2 mg/vial and 5 mg/vial | ➤ Subscribe | 2013-12-27 |
| ➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
| ➤ Subscribe | Nasal Spray | 205.5 mcg/spray | ➤ Subscribe | 2011-12-15 |
| ➤ Subscribe | Sublingual Tablets | 5 mg and 10 mg | ➤ Subscribe | 2010-04-29 |
International Patents for MYLAN Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2072051 | ⤷ Subscribe |
| European Patent Office | 1519731 | ⤷ Subscribe |
| Hungary | E028698 | ⤷ Subscribe |
| Morocco | 27285 | ⤷ Subscribe |
| South Korea | 20130027004 | ⤷ Subscribe |
| Brazil | 122014030158 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MYLAN Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2435024 | C02435024/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021 |
| 2498758 | 2020C/509 | Belgium | ⤷ Subscribe | PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113 |
| 1613288 | 2011/027 | Ireland | ⤷ Subscribe | PRODUCT NAME: GILENYA-FINGOLIMOD; NAT REGISTRATION NO/DATE: EU/1/11/677/001 20110317; FIRST REGISTRATION NO/DATE: EU/1/11/677/002 17/03/2011 IRELAND EU/1/11/677/003 17/03/2011 IRELAND EU/1/11/677/004 20110317 |
| 0663916 | 122004000033 | Germany | ⤷ Subscribe | PRODUCT NAME: EVEROLIMUS; NAT. REGISTRATION NO/DATE: 58387.00.00 58387.00.01 58387.01.00 58387.01.01 58387.02.00 58387.03.00 20040204 FIRST REGISTRATION: SCHWEDEN 18690 18691 18692 18693 18694 18695 20030718 |
| 2861072 | 2024C/512 | Belgium | ⤷ Subscribe | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406 |
| 1467728 | CA 2016 00022 | Denmark | ⤷ Subscribe | PRODUCT NAME: SACUBITRIL/VALSARTAN, HERUNDER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 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.
