TERIPARATIDE - Generic Drug Details
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What are the generic sources for teriparatide and what is the scope of freedom to operate?
Teriparatide
is the generic ingredient in four branded drugs marketed by Alvogen, Lilly, Almaject, Apotex, Teva Pharms Usa, and Sanofi Aventis Us, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Teriparatide has thirty-seven patent family members in twenty-five countries.
There are four drug master file entries for teriparatide. Five suppliers are listed for this compound.
Summary for TERIPARATIDE
International Patents: | 37 |
US Patents: | 1 |
Tradenames: | 4 |
Applicants: | 6 |
NDAs: | 6 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 28 |
Clinical Trials: | 151 |
Drug Prices: | Drug price trends for TERIPARATIDE |
What excipients (inactive ingredients) are in TERIPARATIDE? | TERIPARATIDE excipients list |
DailyMed Link: | TERIPARATIDE at DailyMed |
Recent Clinical Trials for TERIPARATIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Universidade Federal Fluminense | Phase 4 |
Universidad de Valparaiso | Phase 4 |
Peking Union Medical College Hospital | N/A |
Pharmacology for TERIPARATIDE
Drug Class | Parathyroid Hormone Analog |
Anatomical Therapeutic Chemical (ATC) Classes for TERIPARATIDE
Paragraph IV (Patent) Challenges for TERIPARATIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FORTEO | Injection | teriparatide | 250 mcg/mL, 2.4 mL prefilled Pen | 021318 | 1 | 2015-07-27 |
US Patents and Regulatory Information for TERIPARATIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Teva Pharms Usa | TERIPARATIDE | teriparatide | SOLUTION;SUBCUTANEOUS | 208569-001 | Nov 16, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Almaject | TERIPARATIDE | teriparatide | SOLUTION;SUBCUTANEOUS | 218771-001 | Jun 4, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ 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 TERIPARATIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TERIPARATIDE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
STADA Arzneimittel AG | Movymia | teriparatide | EMEA/H/C/004368 Movymia is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Authorised | no | yes | no | 2017-01-11 | |
Eli Lilly Nederland B.V. | Forsteo | teriparatide | EMEA/H/C/000425 Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Authorised | no | no | no | 2003-06-10 | |
Gedeon Richter Plc. | Terrosa | teriparatide | EMEA/H/C/003916 Terrosa is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Authorised | no | yes | no | 2017-01-04 | |
EuroGenerics Holdings B.V. | Qutavina | teriparatide | EMEA/H/C/005388 Qutavina is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
Withdrawn | no | yes | no | 2020-08-27 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TERIPARATIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2007530241 | ⤷ Sign Up | |
Hungary | E045180 | ⤷ Sign Up | |
Australia | 2005231731 | Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose | ⤷ Sign Up |
Eurasian Patent Organization | 200601801 | УСТРОЙСТВО ДЛЯ ДОЗИРОВАНИЯ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ С ПРУЖИННЫМ БЛОКИРУЮЩИМ УСТРОЙСТВОМ, ПРИВОДИМЫМ В ДЕЙСТВИЕ ПРИ ВВЕДЕНИИ ПОСЛЕДНЕЙ ДОЗЫ | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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