Mylan Company Profile
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What is the competitive landscape for MYLAN, and when can generic versions of MYLAN drugs launch?
MYLAN has seven hundred and seven approved drugs.
There are forty-five US patents protecting MYLAN drugs. There are forty-three tentative approvals on MYLAN drugs.
There are three hundred and three patent family members on MYLAN drugs in forty-two countries and one thousand one hundred and forty-six supplementary protection certificates in eighteen countries.
Summary for Mylan
| International Patents: | 303 |
| US Patents: | 45 |
| Tradenames: | 503 |
| Ingredients: | 456 |
| NDAs: | 707 |
| 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 | CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 078702-004 | May 3, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan Asi | AZITHROMYCIN | azithromycin | INJECTABLE;INJECTION | 065506-001 | Mar 24, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mylan | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 090413-003 | Dec 8, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mylan | AMOXICILLIN | amoxicillin | FOR SUSPENSION;ORAL | 062090-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Mylan Institutional | EPIRUBICIN HYDROCHLORIDE | epirubicin hydrochloride | INJECTABLE;INJECTION | 065371-001 | Nov 28, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| >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 | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 7,097,827 | ⤷ Sign Up |
| Mylan Speciality Lp | AEROSPAN HFA | flunisolide | AEROSOL, METERED;INHALATION | 021247-001 | Jan 27, 2006 | 5,980,867 | ⤷ Sign Up |
| Mylan Speciality Lp | DEMADEX | torsemide | TABLET;ORAL | 020136-004 | Aug 23, 1993 | RE30633 | ⤷ Sign Up |
| Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-003 | Nov 19, 1996 | 4,801,587 | ⤷ Sign Up |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-002 | Jul 12, 1996 | 5,866,591*PED | ⤷ Sign Up |
| >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 | 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 | Delayed-release Tablets | 20 mg | ➤ Subscribe | 2015-06-03 |
| ➤ Subscribe | Inhalation Solution | 0.021% and 0.042% | ➤ Subscribe | 2005-10-19 |
| ➤ Subscribe | Inhalation Solution | 300 mg/5 mL | ➤ Subscribe | 2009-06-29 |
| ➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
| ➤ Subscribe | Nasal Spray | 205.5 mcg/spray | ➤ Subscribe | 2011-12-15 |
| ➤ Subscribe | Nasal Spray | 137 mcg/50 mcg per spray | ➤ Subscribe | 2014-06-13 |
| ➤ Subscribe | Topical Foam | 0.05% | ➤ Subscribe | 2005-06-27 |
| ➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
| ➤ Subscribe | Foam | 2% | ➤ Subscribe | 2009-07-30 |
| ➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
| ➤ Subscribe | for Injection | 1 mg/vial, 2 mg/vial and 5 mg/vial | ➤ Subscribe | 2013-12-27 |
| ➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
| ➤ Subscribe | Sublingual Tablets | 5 mg and 10 mg | ➤ Subscribe | 2010-04-29 |
| ➤ Subscribe | Nasal Spray | 0.125 mg base/spray | ➤ Subscribe | 2005-11-14 |
| ➤ Subscribe | Ophthalmic Solution | 0.05% | ➤ Subscribe | 2006-12-13 |
| ➤ Subscribe | Foam | 0.12% | ➤ Subscribe | 2007-08-10 |
| ➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
International Patents for Mylan Drugs
Supplementary Protection Certificates for Mylan Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0770388 | 9/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
| 2822954 | LUC00083 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
| 0984957 | SPC/GB11/013 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 0296749 | 09C0055 | France | ⤷ Sign Up | PRODUCT NAME: ANASTROZOLE, EVENTUELLEMENT SOUS LA FORME D’UN SEL D’ADDITION ACCEPTABLE EN MEDECINE PHARMACEUTIQUE; REGISTRATION NO/DATE IN FRANCE: NL 21126 DU 19961227; REGISTRATION NO/DATE AT EEC: 12619/0106 DU 19950811 |
| 1419152 | C 2012 016 | Romania | ⤷ Sign Up | PRODUCT NAME: COMBINATIE DE RILPIVIRINA SI TOATE FORMELE ECHIVALENTETERAPEUTIC ALE ACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREARILPIVIRINEI CU ACIDUL CLORHIDRIC, SI TENOFOVIR, IN PARTICULAR FUMARAT DE TENOFOVIRDISOPROXIL; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001, EU/1/11/737/002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001, EU/1/11/737/002; DATE OF FIRST AUTHORISATION IN EEA: 20111128 |
| >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.
