When do the BLISOVI FE 1.5/30 patents expire, and when will generic BLISOVI FE 1.5/30 be available?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	BLISOVI FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	201585-001	Nov 18, 2015	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: August 14, 2026

BLISOVI FE 1.5/30 is a mature generic combined oral contraceptive containing norethindrone acetate 1.5 mg, ethinyl estradiol 30 mcg, and ferrous fumarate tablets. Lupin Pharmaceuticals markets the product in the United States. Its commercial outlook is driven by prescription volume, payer formulary placement, pharmacy-channel availability, and generic pricing rather than patent protection. Product-level revenue is not separately disclosed by Lupin, so the financial trajectory is best assessed through market structure, generic competition, and Lupin’s broader U.S. generics performance.[1][2]

What is BLISOVI FE 1.5/30 and who manufactures it?

BLISOVI FE 1.5/30 is a prescription oral contraceptive with 21 active tablets and seven ferrous fumarate tablets. The active hormonal ingredients are norethindrone acetate and ethinyl estradiol. The ferrous fumarate tablets are nonhormonal and are intended to maintain the daily tablet-taking schedule.

Item	Detail
Product	BLISOVI FE 1.5/30
Active ingredients	Norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg
Supplemental tablets	Ferrous fumarate
Dosage form	Oral tablet
Therapeutic category	Combined hormonal contraceptive
U.S. marketer	Lupin Pharmaceuticals, Inc.
Regulatory pathway	Abbreviated New Drug Application, or ANDA
Prescription status	Prescription-only
Reference product class	Norethindrone acetate and ethinyl estradiol oral contraceptive
Primary commercial channel	Retail pharmacy and pharmacy benefit plans

DailyMed identifies the product as a hormonal contraceptive and provides the prescribing information, contraindications, warnings, dosing schedule, and packaging information.[1]

BLISOVI FE 1.5/30 is one strength within the BLISOVI franchise. Other products in the franchise include lower-dose formulations such as BLISOVI FE 1/20 and 24-day regimens. The products compete within a crowded market of generic norethindrone and ethinyl estradiol contraceptives.

How large is the market for BLISOVI FE 1.5/30?

The U.S. market for oral contraceptives is large, established, and heavily genericized. BLISOVI FE 1.5/30 occupies a mature segment rather than a growth category based on product innovation.

Demand is supported by:

Continued use of oral contraception in the United States.
High generic substitution rates.
Broad retail pharmacy distribution.
Coverage through commercial insurance and public programs.
Prescriber familiarity with norethindrone acetate and ethinyl estradiol.
Use of 28-day packaging, which supports routine adherence.

Demand is constrained by competition from other combined oral contraceptives, progestin-only pills, long-acting reversible contraceptives, transdermal systems, vaginal rings, emergency contraception, and branded products with differentiated delivery systems.

The commercial market is less sensitive to clinical differentiation than to availability and reimbursement. Most products in the category have similar active ingredients, and pharmacies frequently substitute among therapeutically equivalent products when payer contracts and inventory permit.

How does BLISOVI FE 1.5/30 compare with competing contraceptives?

Product type	Examples	Competitive advantage	Main pressure on BLISOVI FE 1.5/30
Same active ingredients	Generic norethindrone acetate/ethinyl estradiol	Direct therapeutic substitution	Price and supply competition
Lower-dose formulation	Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg	Lower estrogen exposure for selected patients	Prescriber preference and patient tolerability
24-day regimen	24 active tablets plus placebo or iron tablets	Different withdrawal-bleed schedule	Regimen preference
Progestin-only pill	Norethindrone or newer progestins	Avoids estrogen-related risks	Alternative for patients with estrogen contraindications
Long-acting contraception	Intrauterine devices and implants	High efficacy and low adherence burden	Substitution in contraceptive planning
Branded oral contraceptive	Branded combination products	Brand recognition and formulation positioning	Higher marketing and reimbursement differentiation

BLISOVI FE 1.5/30 has no obvious delivery-system advantage. Its principal commercial attributes are established dosing, generic pricing, and availability.

What is the financial trajectory of BLISOVI FE 1.5/30?

Lupin does not publicly report BLISOVI FE 1.5/30 revenue as a standalone product. The company reports consolidated and segment-level financial results, including U.S. generics performance, but does not provide audited product-level sales, gross margin, prescription volume, or market share for this contraceptive.[2]

The likely financial trajectory has four stages:

Initial generic launch and distribution expansion.
Price erosion as additional ANDA suppliers enter.
Mature, volume-based sales with limited pricing power.
Potential revenue volatility from shortages, discontinuations, payer exclusions, or manufacturing interruptions.

For a mature oral contraceptive, revenue normally depends more on retained prescriptions and supply continuity than on list-price increases. Gross profit can decline even when prescription volume remains stable because pharmacy benefit managers and wholesalers negotiate lower acquisition prices.

What financial metrics matter most?

The most important indicators for BLISOVI FE 1.5/30 are:

Monthly U.S. prescriptions.
Retail and mail-order dispensing volume.
Number of active generic suppliers.
Wholesale acquisition price and average selling price.
Formulary tier placement.
Pharmacy stocking rates.
Back-order frequency and shortage notices.
Lupin’s U.S. generics revenue trend.
Product discontinuation or supply-change notices.
Net revenue per prescription after rebates and discounts.

A product with stable prescriptions can still experience falling revenue if competing suppliers reduce prices. Conversely, temporary supply disruption among competitors can improve volume and pricing for an incumbent supplier.

When does BLISOVI FE 1.5/30 lose exclusivity?

BLISOVI FE 1.5/30 does not have a meaningful remaining product-exclusivity period comparable to a newly approved branded medicine. The underlying active ingredients have been used in oral contraceptives for decades, and the product is marketed through the generic ANDA pathway.

The relevant exclusivity has already been displaced by generic competition. There is no public basis to treat BLISOVI FE 1.5/30 as a patent-protected, single-source product.

Exclusivity category	BLISOVI FE 1.5/30 assessment
New chemical entity exclusivity	Not applicable
Orphan-drug exclusivity	Not applicable
Biologic exclusivity	Not applicable
New-product exclusivity	Not the principal commercial protection
Generic 180-day exclusivity	No current product-level exclusivity should be assumed without an Orange Book review of the relevant ANDA
Patent-based exclusivity	No meaningful blocking estate apparent from the mature generic product profile

The FDA Orange Book identifies approved drug products, therapeutic equivalence information, patent listings for applicable products, and certain exclusivity data.[3] For this product class, the commercial question is not when a branded patent expires. It is how many generic suppliers remain active and whether Lupin retains adequate supply and payer access.

What patents protect BLISOVI FE 1.5/30?

No major product patent estate is publicly associated with BLISOVI FE 1.5/30 as a mature generic contraceptive. The active ingredients and basic oral-tablet use are old technologies. Any historical patents related to norethindrone, ethinyl estradiol, oral contraceptive combinations, tablet composition, or packaging would generally have expired or become commercially irrelevant.

Potential IP categories include:

Historical composition-of-matter patents covering the hormones.
Formulation patents covering tablet excipients or release characteristics.
Manufacturing patents covering granulation, compression, coating, or packaging.
Trademark rights in the BLISOVI name.
Regulatory and commercial know-how involving quality control and supply.

These categories do not create the same barrier as a live, Orange Book-listed patent covering a new chemical entity. The product’s competitive defense is operational rather than patent-based.

Are formulation patents important for BLISOVI FE 1.5/30?

Formulation patents could matter if a supplier developed a genuinely differentiated dosage form, controlled-release profile, or proprietary excipient system. BLISOVI FE 1.5/30 is a conventional oral tablet, and public labeling does not indicate a technically differentiated delivery system.[1]

The ferrous fumarate tablets provide a regimen component, not a high-value delivery technology. Competitors can generally develop equivalent products through standard pharmaceutical formulation and ANDA procedures, subject to FDA requirements for quality, bioequivalence, manufacturing controls, and labeling.

Are there Paragraph IV challenges involving BLISOVI FE 1.5/30?

Paragraph IV litigation is generally associated with an ANDA applicant certifying that a listed patent is invalid, unenforceable, or not infringed. That mechanism is most relevant when a branded reference product has active Orange Book-listed patents.

BLISOVI FE 1.5/30 is itself a generic product. Publicly available product information does not establish an active, commercially significant Paragraph IV dispute specifically directed at the BLISOVI FE 1.5/30 marketed product.

The relevant litigation risks are more likely to involve:

Patent disputes over a branded reference contraceptive.
ANDA litigation between generic companies.
Trademark disputes over product names.
Manufacturing or supply-contract disputes.
Product-liability claims based on class-wide contraceptive risks.

A current FDA Orange Book review and federal court docket search would be required to establish any newly filed case. No active litigation should be inferred solely from the existence of generic competition.

What is the FDA regulatory status of BLISOVI FE 1.5/30?

BLISOVI FE 1.5/30 is an FDA-regulated prescription drug marketed under an ANDA-based generic framework. Its labeling includes the standard safety profile for combined hormonal contraceptives, including risks associated with estrogen-containing products.

Key regulatory issues include:

Contraindications in patients with certain thrombotic, cardiovascular, hepatic, or migraine-related risks.
Warnings regarding smoking and age.
Drug interactions that can reduce contraceptive effectiveness.
Bioequivalence and content-uniformity requirements.
Current good manufacturing practice compliance.
Accurate labeling and packaging.
Postmarket adverse-event reporting.

The product is not a biologic and has no biosimilar exposure. Biosimilars do not compete with small-molecule oral contraceptives. The relevant substitutes are other generics and non-biologic contraceptive methods.

Which companies challenge BLISOVI FE 1.5/30 commercially?

Competition comes from manufacturers of therapeutically equivalent norethindrone acetate and ethinyl estradiol tablets, as well as suppliers of alternative contraceptive regimens. The competitive field can include large generic companies, specialty pharmaceutical manufacturers, contract manufacturers, and private-label suppliers.

The most important competitors are not necessarily those with the strongest brands. They are the companies able to:

Maintain uninterrupted supply.
Offer competitive wholesale pricing.
Secure favorable pharmacy benefit coverage.
Keep the product active across major wholesalers.
Respond to demand shifts and manufacturing shortages.
Supply multiple strengths and package configurations.

Lupin’s scale in U.S. generics gives it distribution and manufacturing advantages, but it also operates in categories where price competition can be severe.[2]

What generic entry risks exist for BLISOVI FE 1.5/30?

Generic entry risk is already embedded in the product’s business model. The main risks are incremental rather than transformational.

Price erosion

Additional suppliers can lower average selling prices and compress gross margins. Contraceptive tablets are relatively standardized, which reduces the ability to preserve premium pricing.

Substitution by lower-dose products

Patients and prescribers may move between 1.5/30 and 1/20 strengths based on tolerability, bleeding patterns, or clinical preference.

Formulary exclusion

Payers may designate another generic supplier as preferred. Pharmacy benefit managers can shift volume through rebate and pricing arrangements.

Supply disruption

A manufacturing interruption can cause lost sales and potential product substitution. The same event can also benefit Lupin if competing suppliers are unavailable.

Channel concentration

Heavy dependence on large wholesalers and national pharmacy chains increases customer bargaining power. The product’s commercial performance can weaken even if overall contraceptive demand remains stable.

How strong is the BLISOVI FE 1.5/30 patent estate?

The patent estate is weak as a commercial moat. The product has the characteristics of a mature generic:

Old active ingredients.
No apparent active new-chemical-entity protection.
No biologic exclusivity.
No known differentiated delivery system.
Multiple potential generic suppliers.
Primary dependence on manufacturing, distribution, and payer access.

Its defensibility is therefore operational. Lupin’s advantage may come from regulatory approval, validated manufacturing, customer relationships, and the ability to supply consistently. Those advantages can support share retention but do not prevent market entry.

What licensing deals affect BLISOVI FE 1.5/30?

No major product-specific licensing transaction is prominently disclosed in public company filings for BLISOVI FE 1.5/30. Lupin has used acquisitions, licensing arrangements, and portfolio transactions across its broader pharmaceutical business, but public reporting does not isolate a licensing stream for this product.[2]

Any third-party arrangements could affect economics through:

Contract manufacturing costs.
Supply rights.
Territory restrictions.
Technology-transfer obligations.
Royalty payments.
Packaging and distribution agreements.

The absence of disclosed product-level royalties supports an assessment that BLISOVI FE 1.5/30 is primarily a conventional generic commercial product rather than a royalty-bearing specialty asset.

What is the outlook for BLISOVI FE 1.5/30 revenue?

The base-case outlook is stable to declining nominal revenue, with potential volume resilience. The product is unlikely to generate material growth through price expansion or patent-backed exclusivity.

Driver	Expected effect
Stable contraceptive demand	Supports prescription volume
Generic competition	Reduces price and margin
Lupin supply reliability	Supports share retention
Payer preference changes	Can rapidly shift volume
Competitor shortages	Can temporarily improve sales
Product discontinuation risk	Creates replacement and substitution pressure
Portfolio breadth	Helps Lupin retain pharmacy relationships
Patent expiry	Limited incremental effect because the product is already generic

For investors, BLISOVI FE 1.5/30 is more relevant as part of Lupin’s U.S. generics portfolio than as an individually material revenue asset. Its value lies in recurring prescription volume, manufacturing utilization, and channel presence. The product is unlikely to alter Lupin’s consolidated financial trajectory unless it experiences a significant supply event or becomes part of a broader contraceptive portfolio expansion.

Key Takeaways

BLISOVI FE 1.5/30 is a mature generic combined oral contraceptive marketed by Lupin Pharmaceuticals.
It contains norethindrone acetate 1.5 mg, ethinyl estradiol 30 mcg, and ferrous fumarate tablets.
Product-level revenue, margin, and prescription data are not separately disclosed by Lupin.
The product has no meaningful remaining exclusivity moat based on its mature generic profile.
Competition is driven by generic pricing, payer formularies, pharmacy availability, and supply continuity.
Formulation and manufacturing IP may support operations but do not appear to create a significant barrier to generic entry.
Paragraph IV and biosimilar risks are not central to the current commercial outlook.
The likely financial trajectory is recurring volume with pricing pressure and periodic upside from competitor supply disruptions.
BLISOVI FE 1.5/30 is more important as a portfolio and channel product than as a standalone high-growth asset.

FAQs

Does BLISOVI FE 1.5/30 have a brand-name premium?

No. BLISOVI FE 1.5/30 is marketed as a generic prescription contraceptive, and its pricing is generally shaped by generic competition, payer contracts, and pharmacy purchasing arrangements.

Is BLISOVI FE 1.5/30 interchangeable with Microgestin Fe 1.5/30?

Products with the same active ingredients and strength may be therapeutically equivalent, but substitution depends on FDA therapeutic-equivalence status, state pharmacy law, payer rules, and the specific product listing.

Can BLISOVI FE 1.5/30 face a drug shortage?

Yes. Like other generic oral tablets, it can face temporary supply disruption from manufacturing, quality, raw-material, packaging, or distribution problems. A shortage involving competing suppliers can also increase demand for Lupin’s product.

Does ferrous fumarate make BLISOVI FE 1.5/30 clinically differentiated?

The ferrous fumarate tablets help maintain the 28-day dosing routine. They do not create a major proprietary delivery advantage or materially change the product’s generic competitive profile.

Is BLISOVI FE 1.5/30 exposed to biosimilar competition?

No. BLISOVI FE 1.5/30 is a small-molecule oral tablet. Its competitive exposure is to generic oral contraceptives and non-biologic contraceptive methods, not biosimilars.

References

DailyMed. (n.d.). BLISOVI FE 1.5/30: Norethindrone acetate, ethinyl estradiol, and ferrous fumarate tablet labeling. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
Lupin Limited. (2024). Annual report 2023-24. https://www.lupin.com/
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	BLISOVI FE 1.5/30 at DailyMed

BLISOVI FE 1.5/30 Drug Patent Profile

When do Blisovi Fe 1.5/30 patents expire, and what generic alternatives are available?

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Summary for BLISOVI FE 1.5/30

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